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Carl D Regillo,1 Lisa M Nijm,2 Diana L Shechtman,3 Peter K Kaiser,4 Paul M Karpecki,5 Edwin H Ryan,6 Michael S Ip,7 Elizabeth Yeu,8 Terry Kim,9 Mohammad R Rafieetary,10 Eric D Donnenfeld11 1Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA; 2Warrenville Eye Care and LASIK Center, Warrenville, IL, USA; 3Eye Centers of South Florida, North Miami Beach, FL, USA; 4Cole Eye Institute, Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA; 5Kentucky College of Optometry, University of Pikeville, Pikeville, KY, USA; 6Retina Consultants of Minnesota, Edina, MN, USA; 7Doheny Eye Center UCLA, Pasadena, CA, USA; 8Virginia Eye Consultants, Norfolk, VA, USA; 9Duke University, Durham, NC, USA; 10Charles Retina Institute, Germantown, TN, USA; 11Ophthalmic Consultants of Long Island, Garden City, NY, USACorrespondence: Carl D Regillo, Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, 840 Walnut St # 1020, Philadelphia, PA, 19107, USA, Tel +1 (215) 928-3300, Email cregillo@midatlanticretina.comAbstract: Newly approved treatments for patients with geographic atrophy are changing the treatment paradigm, highlighting the need for eye care providers (ECPs) to have a set of recommendations on how to best manage GA patients. Here, we outline how to identify various stages of age-related macular degeneration including geographic atrophy (GA) by examining optimal management scenarios implicating various ECPs and reviewing treatment considerations for patients with GA. Early identification of GA will lead to optimal patient outcomes, while a standardized management scenario will reduce clinical burden among ECPs treating patients with GA.Keywords: age-related macular degeneration, patient care, retina, treatment

Eric D Donnenfeld,1 John A Hovanesian,2 Aysha G Malik,1 Aidan Wong1 1Ophthalmic Consultants of Long Island, New York, NY, USA; 2Harvard Eye Associates, Laguna Hills, CA, USACorrespondence: Eric D Donnenfeld, Ophthalmic Consultants of Long Island (OCLI), 711 Stewart Avenue, Suite 160, Garden City, New York, NY, 11530, USA, Tel +1 516-500-4200, Fax +1 516-742-0017, Email ericdonnenfeld@gmail.comPurpose: To evaluate clinical efficacy and patient preference for a dropless treatment regimen compared to conventional topical therapy in patients undergoing cataract surgery.Patients and Methods: In this prospective, contralateral eye study, patients with bilateral cataract were randomized to receive either intracanalicular dexamethasone insert, intracameral phenylephrine 1%/ketorolac 0.3%, and intracameral moxifloxacin (50 μg) (study group) or topical moxifloxacin 0.5%, ketorolac 0.5%, and prednisolone acetate 1.0% QID (control group). The second eye underwent cataract surgery 2 weeks later and was treated with the opposite treatment. All patients were evaluated at Days 1, 7, 14, 28, and 3 months. The primary outcome measure was postoperative ocular pain. Secondary outcomes included summed ocular inflammation score (SOIS; the sum of the mean anterior chamber cells and anterior flare score), the patient preference for medication protocol between the two eyes, and patient out-of-pocket cost of medications. Safety outcome measures included CDVA, intraocular pressure, central retinal thickness (CRT), and the incidence of reported AEs.Results: The proportion of patients with no pain was similar in both groups at all postoperative visits (p> 0.05). No statistically significant difference in SOIS score was observed between the two groups at any visit. A strong majority of the patients (94.7%) preferred the study eye’s dropless regimen over the control eye’s conventional topical therapy regimen. No statistically significant difference in mean intraocular pressure (IOP) was observed at any postoperative visit, except at Week 1. The mean CDVA was also similar in both groups at all postoperative visits (p> 0.05). The postoperative mean CRT was comparable between the two groups.Conclusion: A dropless treatment regimen is as effective as topical eyedrop administration. A higher proportion of patients who underwent bilateral cataract surgery preferred the dropless treatment regimen over the patient-administered eye drop regimen.Keywords: dropless cataract surgery, intracanalicular dexamethasone insert, dropless vs topical eyedrop administration, sustained-release steroid delivery, drop-free treatment regimen

Kelly K Nichols,1 Eric D Donnenfeld,2 Charis Lau,3 Annie Syntosi,4 Paul Karpecki,5 John A Hovanesian6,7 1School of Optometry, University of Alabama at Birmingham, Birmingham, AL, USA; 2New York University Medical Center, New York, NY, USA; 3Retina Global Medical Affairs, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 4Retina Global Patient Access, Novartis Pharma AG, Basel, Switzerland; 5Kentucky Eye Institute, Lexington, KY, USA; 6Harvard Eye Associates, Laguna Hills, CA, USA; 7UCLA Jules Stein Eye Institute, Los Angeles, CA, USACorrespondence: John A Hovanesian, Harvard Eye Associates, 24401 Calle de la Louisa, Suites 300-312, Laguna Hills, CA, 92653, USA, Tel +1 949-742-3937, Fax +1 844-479-0584, Email johnhova@gmail.com; jhovanesian@HarvardEye.comPurpose: To assess the frequency of patients reducing the use of artificial tears (ATs) among patients with dry eye disease (DED) following lifitegrast treatment.Patients and Methods: Two independent analyses were performed using the data from the 1-year, randomized, multicenter, Phase 3 SONATA trial and a noninterventional, real-world evidence (RWE) study conducted in patients with DED who were treated with lifitegrast in the United States and Canada. In SONATA, patients who had used ATs in the lifitegrast and placebo groups were included. The RWE study reviewed patients’ electronic medical records, prescribing patterns, and practices of physicians throughout the survey. These data were then used to compare the proportion of patients using ATs in the 6-month pre-index period versus the 12-month post-index period.Results: Of 293 patients (lifitegrast, n=195; placebo, n=98) from SONATA, 107 (lifitegrast, n=64; placebo, n=43) used ATs during the on-therapy period while 186 (lifitegrast, n=131; placebo, n=55) did not. Of those not using ATs, the proportion of patients in the lifitegrast group at any time was higher (∼ 67% [n=131]) versus placebo (∼ 56% [n=55]); this was the case at all study time-points (Days 90, 180, 270, and 360). The RWE study included 600 patient charts (US, n=550; Canada, n=50); 75.5% (n=453) reported AT use. There was ∼ 40% decrease in the proportion of patients using ATs as adjunct DED therapy to lifitegrast in the post-index period (n=273) versus those in the pre-index period (n=453).Conclusion: The findings show that the reliance on AT use can be gradually reduced with lifitegrast treatment, eventually leading to a reduction in disease burden.Keywords: dry eye disease, lifitegrast, artificial tears, SONATA, real-world evidence, chart review

John Hovanesian,1 Alice Epitropoulos,2 Eric D Donnenfeld,3 Jack T Holladay4 1Harvard Eye Associates, Laguna Hills, CA, USA; 2Ophthalmic Surgeons & Consultants of Ohio, Columbus, OH, USA; 3Ophthalmic Consultants of Long Island, Garden City, NY, USA; 4Baylor College of Medicine, Houston, TX, USACorrespondence: John HovanesianHarvard Eye Associates, 24401 Calle De La Louisa, Laguna Hills, CA 92653, USATel +1 949 951 2020Fax +1 949 951 9244Email jhovanesian@harvardeye.comPurpose: To determine the effect of lifitegrast ophthalmic solution 5% on improving the tear film, biometry/keratometry, and refractive accuracy for dry eye patients scheduled for cataract surgery.Patients and Methods: Multicenter, prospective, open-label study of 100 eyes of 100 patients undergoing cataract surgery who had a confirmed diagnosis of dry eye. Patients underwent biometry at baseline and again after a 28-day course of lifitegrast 5% BID. Primary outcome was an improvement in the accuracy of preoperative anterior corneal power measurements at predicting postoperative spherical equivalent (SE) pre- and post-lifitegrast treatment. Secondary outcomes included changes in dry eye symptoms and corneal staining.Results: The accuracy of the biometry readings for the achieved refractive SE: within 0.25 D in 47% and 50% of eyes before and after the initial lifitegrast treatment, respectively; within 0.5 D in 71% and 79% of eyes before and after the initial lifitegrast treatment; and within 0.75 D in 81% and 91% of eyes before and after the initial lifitegrast treatment (p < 0.04).Conclusion: Lifitegrast 5% significantly improved preoperative corneal surface measurement accuracy in patients with confirmed dry eye who were scheduled for cataract surgery.Keywords: cataract surgery, dry eye, lifitegrast, higher-order aberrations

Helga P Sandoval,1 Stephen Lane,2 Stephen Slade,3 Eric D Donnenfeld,4 Richard Potvin,5 Kerry D Solomon1 1Carolina Eyecare Physicians, LLC, Mt. Pleasant, SC, USA; 2Associated Eye Care, Stillwater, MN, USA; 3Slade & Baker Vision, Houston, TX, USA; 4Ophthalmic Consultants of Long Island, Long Island, NY, USA; 5Science in Vision, Bend, OR, USACorrespondence: Kerry D SolomonCarolina Eyecare Physicians, LLC, 1101 Clarity Road, Suite 100, Mt Pleasant, SC 29464, USAEmail kerry.solomon@carolinaeyecare.comPurpose: To evaluate the rotational stability of a toric extended depth of focus (EDOF) intraocular lens (IOL), using either slit lamp evaluation or image-processing software.Setting: Three clinical practices in the USA.Design: Prospective unmasked randomized clinical trial.Methods: Subjects presenting for routine cataract surgery that were interested in improved near vision received toric EDOF lenses (TECNIS Symfony® Toric) in both eyes. The measures of interest in the current analysis were the change in orientation of the IOL between 1 day, 1 month and 3 months postoperative. Orientation was measured at the microscope on the day of surgery, and with the slit lamp at all other visits. Day 1, 1-month and 3-month images of the lens orientation were captured with a slit lamp camera. Differences in orientation were recorded and analyzed.Results: A total of 150 eyes had IOL orientation data available. Image analysis showed mean absolute lens orientation changes from 1 day to 1 month and 3 months of less than 2 degrees. The percentage of lenses exhibiting rotation of ≤ 5 degrees between any measured time points was 97% or higher. Results were similar, but significantly more variable, when IOL orientation was measured at the slit lamp.Conclusion: The toric EDOF lens evaluated here demonstrated rotational stability that exceeded the prior ANSI standard. The best method to determine IOL orientation changes was through image analysis.  Keywords: TECNIS symfony toric, toric IOL, rotational stability

Helga P Sandoval,1 Stephen Lane,2 Stephen G Slade,3 Eric D Donnenfeld,4 Richard Potvin,5 Kerry D Solomon1 1Carolina Eyecare Physicians, LLC, Mt. Pleasant, SC, USA; 2Associated Eye Care, Stillwater, MN, USA; 3Slade & Baker Vision, Houston, TX, USA; 4Ophthalmic Consultants of Long Island, Long Island, NY, USA; 5Science in Vision, Akron, NY, USACorrespondence: Kerry D SolomonCarolina Eyecare Physicians, LLC, 1101 Clarity Road, Suite 100, Mt Pleasant, SC 29464, USAEmail kerry.solomon@carolinaeyecare.comPurpose: To evaluate the defocus curve and patient satisfaction after implantation of an extended depth of focus (EDOF) toric IOL when both eyes were targeted for emmetropia and when the non-dominant eye was targeted for mini monovision (− 0.50D).Methods: A prospective unmasked randomized clinical trial in three clinical practices in the USA. Subjects presenting for routine cataract surgery were assigned to one of two groups, both receiving bilateral toric EDOF lenses. One group had the non-dominant eye targeted for slight myopia (− 0.50D). Measures of interest were the postoperative defocus curve and reported patient satisfaction and visual disturbances.Results: Questionnaire and defocus curve data were available from 37 subjects in the Emmetropia group, while the mini monovision group included questionnaire data from 39 subjects and valid defocus curve data from 14 subjects. Mini monovision subjects had significantly better VA (a half line to a line better, p < 0.05), from a defocus of − 1.50 D to − 3.00 D. Reported spectacle wear and satisfaction were not significantly different between groups at any distance, but more patients in the mini monovision group reported the ability to function comfortably without glasses at near and overall (near p = 0.02, overall p < 0.01). Halos and starbursts were the two phenomena reported most often for both groups, with reported starbursts slightly more common in the mini monovision group.Conclusions: A slightly myopic correction in the non-dominant eye improved binocular near vision by 0.5 to 1.0 lines based on defocus curve data. Patients reported better functional vision, but with a slight increase in reported starbursts in the mini monovision group.Keywords: symfony, extended depth of focus, intraocular lens, cataract surgery, monovision

Eric D Donnenfeld,1 Ryan D Shojaei2 1Department of Ophthalmology, New York University, New York, NY, USA; 2Ophthalmic Consultants of Long Island, Westbury, NY, USACorrespondence: Eric D DonnenfeldOCLI, 711 Stewart Avenue, Suite 160, Garden City, NY 11530, USATel +1 516 500 4200Fax +1 516 742 0017Email ericdonnenfeld@gmail.comPurpose: To compare the effect of Omidria (phenylephrine and ketorolac 1.0%/0.3%) vs epinephrine on pain reduction and opioid usage during cataract surgery.Patients and methods: Sixty patients at a single center underwent femtosecond laser (FLACS) or conventional phacoemulsification under topical lidocaine gel anesthesia and intracameral preservative-free lidocaine 1%. Eligible participants were prospectively assigned to receive either intracameral phenylephrine and ketorolac 1.0%/0.3% or intracameral epinephrine. All patients received standardized pre- and post-operative topical therapy. Intravenous (IV) fentanyl was administered for ocular discomfort in patients who complained of intraoperative pain. Outcome measures included both pain (measured by mean visual analog scale (VAS) pain scores from 0 (no pain) to 10 (extreme pain)) and the use of IV fentanyl during surgery. A composite endpoint identified “responders” as being patients who: (1) did not require fentanyl and (2) experienced no to minimal pain (VAS score ≤ 3).Results: Forty-one patients were in the phenylephrine and ketorolac 1.0%/0.3% (study) group and 19 were in the epinephrine (control) group. Mean VAS pain scores were significantly (48.9%) lower in the study group than the control group (2.3 vs 4.5; P < 0.0001). The proportion of patients with VAS scores ≤ 3 was significantly greater in the study group (85.0%) than the control group (31.6%) (P < 0.0001). A smaller proportion of patients required intraoperative fentanyl in the study group compared to the control group (9.8% vs 42.1%; P = 0.006). For the composite endpoint, patients receiving phenylephrine and ketorolac 1.0%/0.3% were 94% less likely to require fentanyl or to have moderate-to-severe pain (pain VAS ≥ 4; OR, 0.06; 95% CI 0.02–0.24) than patients receiving epinephrine.Conclusion: Our results suggest that the routine use of intracameral phenylephrine and ketorolac 1.0%/0.3% during cataract surgery can significantly reduce patient pain as well as the need for opioids.Keywords: epinephrine, Omidria, ketorolac, phacoemulsification, FLACS

Alanna Nattis,1 Henry D Perry2,3 Eric D Rosenberg,4 Eric D Donnenfeld51Department of Ophthalmology, Lindenhurst Eye Physicians and Surgeons, P.C., Babylon, NY 11702, USA; 2Department of Ophthalmology, Nassau University Medical Center, East Meadow, NY 11554, USA; 3Department of Ophthalmology, Ophthalmic Consultants of Long Island, Rockville Centre, NY 11570, USA; 4Department of Ophthalmology, New York Medical College, Valhalla, NY 10595, USA; 5Department of Ophthalmology, Ophthalmic Consultants of Long Island, Garden City, NY 11530, USAPurpose: Bacterial burden on the eyelid margin and within meibomian glands was evaluated for influence on specific ocular surface disease (OSD) markers across the meibomian gland dysfunction (MGD) spectrum.Methods: In this prospective, observational, single-center study, 40 patients were divided into 4 equal groups of 10 that encompassed increasingly worse MGD/OSD categories. All patients answered the standard Ocular Surface Disease Index questionnaire, and underwent tear osmolarity testing (TOT), Schirmer 1, matrix metalloproteinase 9 (MMP-9) testing, meibography, and lissamine green staining. Cultures of eyelid margins and meibomian gland secretions were directly plated on blood, chocolate, and Sabouraud agar; smears were sent for gram and Papinicolau evaluation.Results: Mean patient age was 55.25±17.22 years; there were 10 males and 30 females. TOT and MMP-9 testing were similar across groups. Culture positivity was 62.5% for right eyes, 70% for left eyes, and was not statistically different across groups (for both eyelid margin and meibomian glands). The majority of cultures were positive for coagulase-negative staphylococcus (CNS).Conclusion: This study is in concordance with others, citing the predominance of CNS within the biofilm of both “normal” and clinically significant MGD/OSD patients. Our study exemplifies that symptoms of OSD do not necessarily correlate with degree of clinical exam findings, nor culture positivity. These results argue that bacterial burden should be reconsidered as a direct risk factor and treatment target for MGD/OSD patients.Keywords: blepharitis, biofilm, dry eye, meibomian gland dysfunction, ocular surface disease

Eric D Rosenberg,1 Alanna S Nattis,2 David Alevi,3 Rachel L Chu,4 Joseph Bacotti,3 Ronald J LoPinto,3 Gerald D’Aversa,3 Eric D Donnenfeld51New York Medical College, Valhalla, NY, 2Lindenhurst Eye Physicians and Surgeons, Babylon, NY, 3Ophthalmic Consultants of Long Island, Rockville Centre, NY, 4Cornell University, Ithaca, NY, 5New York University Medical Center, New York, NY, USA Aim: The purpose of this study was to compare visual outcomes, surgical time, and perioperative surgical complications after intracameral use of either phenylephrine/ketorolac (P/K) or epinephrine (Epi) during cataract surgery.Methods: This was a single-center, retrospective case review of patients undergoing cataract surgery from August to November 2015. Of the 641 eyes of 389 patients who underwent cataract surgery, 260 eyes were administered phenylephrine 1.0%/ketorolac 0.3% and 381 eyes received Epi in the irrigation solution intraoperatively. All patients received a topical nonsteroidal anti-inflammatory drug regimen (bromfenac 0.07%, nepafenac 0.3%, or ketorolac 0.5%) for 3 days before surgery and topical tropicamide 1.0%, cyclopentolate 1.0%, and phenylephrine 2.5% on the day of surgery.Results: Mean length of surgery (LOS) was 15.4±0.6 minutes. Although a positive correlation was noted between patient age and LOS (p

William B Trattler,1 Parag A Majmudar,2 Eric D Donnenfeld,3 Marguerite B McDonald,4 Karl G Stonecipher,5 Damien F Goldberg6 On behalf of the PHACO Study Group 1Center for Excellence in Eye Care, Miami, FL, USA; 2Chicago Cornea Consultants, Chicago, IL, USA; 3Ophthalmic Consultants of Long Island, Garden City, NY, USA; 4Ophthalmic Consultants of Long Island, Lynbrook, NY, USA; 5University North Carolina School of Medicine, Chapel Hill, NC, USA; 6Wolstan & Goldberg Eye Associates, Torrance, CA, USA Purpose: To determine the incidence and severity of dry eye as determined by the International Task Force (ITF) scale in patients being screened for cataract surgery.Patients and methods: This was a prospective, multi-center, observational study of 136 patients, at least 55 years of age, who were scheduled to undergo cataract surgery. The primary outcome measure was the incidence of dry eye as evaluated by grade on the ITF scale and secondary outcome measures include tear break-up time (TBUT), ocular surface disease index score, corneal staining with fluorescein, conjunctival staining with lissamine green, and a patient questionnaire to evaluate symptoms of dry eye.Results: Mean patient age was 70.7 years. A total of 73.5% of patients were Caucasian and 50% were female. Almost 60% had never complained of a foreign body sensation; only 13% complained of a foreign body sensation half or most of the time. The majority of patients (62.9%) had a TBUT ≤5 seconds, 77% of eyes had positive corneal staining and 50% of the eyes had positive central corneal staining. Eighteen percent had Schirmer’s score with anesthesia ≤5 mm.Conclusion: The incidence of dry eye in patients scheduled to undergo cataract surgery in a real-world setting is higher than anticipated. Keywords: cataract surgery screening, dry eye, International Task Force scale, observational study

David F Chang,1 Eric D Donnenfeld,2 L Jay Katz,3 Lilit Voskanyan,4 Iqbal Ike K Ahmed,5 Thomas W Samuelson,6 Jane Ellen Giamporcaro,7 Dana M Hornbeak,7 Kerry D Solomon8 1Altos Eye Physicians, Los Altos, CA, 2Ophthalmic Consultants of Long Island, Rockville Centre, NY, 3Department of Ophthalmology, Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA; 4S.V. Malayan Ophthalmology Centre, Yerevan, Armenia; 5Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada; 6Minnesota Eye Consultants, Minneapolis, MN, 7Glaukos Corporation, San Clemente, CA, 8Carolina Eyecare Physicians, Mount Pleasant, SC, USA Purpose: To evaluate the long-term intraocular pressure (IOP)-lowering effect and safety parameters following treatment with two trabecular micro-bypass stents and topical prostaglandin in phakic eyes with open-angle glaucoma (OAG) not controlled on two preoperative medications. Methods: This prospective, single-arm, unmasked study enrolled 39 qualified phakic eyes with OAG not controlled on 2 medications, preoperative medicated IOP of 18–30 mmHg, and IOP following medication washout of 22–38 mmHg. Two trabecular micro-bypass stents were implanted as a standalone procedure, and travoprost was started on postoperative day 1. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit-lamp examinations, visual field, cup:disc ratio, central corneal thickness, and ocular complications. Data through 18 months were summarized previously. Thirty-seven of the original 39 subjects have been followed for 3 years postoperatively; follow-up is continuing for 5 years. Results: At 3 years postoperative, 97% of eyes had achieved an IOP reduction of ≥20% from baseline with a reduction of 1 medication. Eighty-six percent of eyes had IOP of ≤18 mmHg with a reduction of 1 medication. Mean medicated IOP decreased to 14.0±2.6 mmHg on 1 medication versus 22.4±2.3 mmHg on 2 medications preoperatively. The mean unmedicated IOP decreased to 17.7±1.7 mmHg at 37 months from 25.3±1.9 mmHg preoperatively. Long-term postoperative adverse events included cataract surgery in 3 eyes due to cataract progression, and trabeculectomy in 1 eye due to uncontrolled IOP of 23 mmHg. No intraoperative or device-related adverse events occurred. Conclusion: Significant and sustained reduction in IOP and medications with a favorable safety profile was shown through 3 years after implantation of 2 trabecular micro-bypass stents combined with postoperative travoprost in phakic OAG eyes uncontrolled on 2 preoperative medications. These findings demonstrate the long-term performance and safety of trabecular bypass stents in combination with topical prostaglandin for OAG patients. Keywords: glaucoma, trabecular micro-bypass, MIGS, IOP, medication

Eric D Donnenfeld,1 Kerry D Solomon,2 Lilit Voskanyan,3 David F Chang,4 Thomas W Samuelson,5 Iqbal Ike K Ahmed,6 L Jay Katz7 1Ophthalmic Consultants of Long Island, Rockville Centre, NY, 2Carolina Eyecare Physicians, Mt Pleasant, SC, USA; 3S.V. Malayan Ophthalmology Centre, Yerevan, Armenia; 4Altos Eye Physicians, Los Altos, CA, 5Minnesota Eye Consultants, Minneapolis, MN, USA; 6University of Toronto, Toronto, ON, Canada; 7Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA Purpose: To evaluate 3-year safety and intraocular pressure (IOP) following two trabecular microbypass stents in phakic and pseudophakic subjects with open-angle glaucoma (OAG) not controlled on preoperative medication. Patients and methods: In this prospective pilot study, phakic or pseudophakic subjects with OAG and IOP between 18 mmHg and 30 mmHg on one preoperative topical ocular hypotensive medication underwent medication washout. Thirty-nine qualified subjects with preoperative unmedicated IOP ≥22 mmHg and ≤38 mmHg received two stents. Postoperative examinations were scheduled at Day 1, Week 1, Months 1, 3, 6, and 12, and semiannually through Month 60. Ocular hypotensive medication was considered if postoperative IOP exceeded 21 mmHg. IOP, medication use, and safety were assessed at each visit. Subject follow-up through Month 36 was completed. Results: Thirty-six eyes (92.3%; 95% confidence interval [CI] 79.1%, 98.4%) achieved the primary efficacy end point of Month 12 reduction in IOP ≥20% from baseline (unmedicated IOP) without ocular hypotensive medication. Four subjects required medication during the Month 36 follow-up period. Mean IOP at 36 months for subjects not taking medication was 15.2 mmHg. At 36 months, subjects sustained mean IOP decrease of 9.1±2.7 mmHg (95% CI 8.0 mmHg, 10.14 mmHg), or 37% IOP reduction, from unmedicated baseline IOP. Compared to preoperative medicated IOP, subjects had mean reduction at Month 36 of 5.5±2.7 mmHg (95% CI 4.5 mmHg, 6.6 mmHg), or 26% reduction. Both measures of IOP reduction were highly significant (P

Purpose: The academic success of ophthalmology fellows may be significantly impacted by their research engagement. Evaluating the research activity of fellows by subspecialty may provide insight into trends useful for prospective applicants. The objective of this study was to assess the research activity of ophthalmology fellows in the year 2023., Methods: Ophthalmology fellowship programs were compiled using the Association of University Professors of Ophthalmology and the American Society of Ophthalmic Plastic and Reconstructive Surgery websites. Program subspecialties were categorized as: Cornea and External Disease [CED]; Cornea, External Disease, and Refractive Surgery [CEDRS]; Glaucoma; Medical Retina [MR]; Neuro-Ophthalmology [NO]; Oculoplastics; Pediatric Ophthalmology [PO]; Surgical Retina [SR]; Uveitis; and Other. "Other" consisted of Oncology, Pathology, combined Oncology and Pathology fellowships. We identified current fellows using publicly available online information. Programs and fellows that did not have information available were excluded. Total publications, Hirsch index (h-index), and weighted-relative citation ration (w-RCR) were utilized as measures of research output, while total citations and mean-RCR (m-RCR) served as proxies for research impact. Duration of publishing was calculated using the years of the oldest and most recent publications. Statistical analysis was performed using Kruskal-Wallis H tests with an alpha value of .05., Results: A total of 373 fellows from 229 programs met our inclusion criteria. More than half of fellows were men (54.4%), and the most common degree type was MD (93.0%). Across all subspecialties, the median h-index was 3.0 (IQR = 4), m-RCR was .9 (IQR = 1.2) and w-RCR was 3.2 (IQR = 9.8). The median number of publications was six (IQR = 10, with 34 citations (IQR = 110) and 4 years of publishing (IQR = 6). We observed significant differences in h-index ( p  = .038), total publications ( p  < .001), and w-RCR ( p  = .028) by subspecialty., Conclusion: We observed significant differences in research output, but no differences in research impact by subspecialty. Overall, Uveitis and Oculoplastics fellows had higher research activity, while Medical Retina and Other fellows had the lowest. This data is pertinent to better understand the landscape of ophthalmology fellowship applications.

Purpose: To evaluate the safety and efficacy of lotilaner ophthalmic solution 0.25% compared with vehicle for the treatment of Demodex blepharitis., Design: Prospective, randomized, double-masked, vehicle-controlled, multicenter, phase 3 clinical trial., Participants: Four hundred twelve patients with Demodex blepharitis were assigned randomly in a 1:1 ratio to receive either lotilaner ophthalmic solution 0.25% (study group) or vehicle without lotilaner (control group)., Methods: Patients with Demodex blepharitis treated at 21 United States clinical sites were assigned either to the study group (n = 203) to receive lotilaner ophthalmic solution 0.25% or to the control group (n = 209) to receive vehicle without lotilaner bilaterally twice daily for 6 weeks. Collarettes and erythema were graded for each eyelid at screening and at all visits after baseline. At screening and on days 15, 22, and 43, 4 or more eyelashes were epilated from each eye, and the number of Demodex mites present on the lashes was counted with a microscope. Mite density was calculated as the number of mites per lash., Main Outcome Measures: Outcome measures included collarette cure (collarette grade 0), clinically meaningful collarette reduction to 10 collarettes or fewer (grade 0 or 1), mite eradication (0 mites/lash), erythema cure (grade 0), composite cure (grade 0 for collarettes as well as erythema), compliance with the drop regimen, drop comfort, and adverse events., Results: At day 43, the study group achieved a statistically significant (P < 0.0001) higher proportion of patients with collarette cure (56.0% vs. 12.5%), clinically meaningful collarette reduction to 10 collarettes or fewer (89.1% vs. 33.0%), mite eradication (51.8% vs. 14.6%), erythema cure (31.1% vs. 9.0%), and composite cure (19.2% vs. 4.0%) than the control group. High compliance with the drop regimen (mean ± standard deviation, 98.7 ± 5.3%) in the study group was observed, and 90.7% of patients found the drops to be neutral to very comfortable., Conclusions: Twice-daily treatment with lotilaner ophthalmic solution 0.25% for 6 weeks generally was safe and well tolerated and met the primary end point and all secondary end points for the treatment of Demodex blepharitis compared with vehicle control., Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article., (Copyright © 2023 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

A clear corneal incision (CCI) is the most commonly used entrance site in modern phacoemulsification cataract surgery. Despite some initial concerns about increased endophthalmitis rates through a self-sealing CCI, recent literature suggests that the risk of infection with proper wound construction and all other necessary precautions is minimal. The technique of creating a clear corneal incision has, with recent developments in corneal imaging, undergone critical appraisal leading to a better understanding of incision architecture. Many surgeons operate through smaller incisions, and they have a wide choice of surgical instruments to create their corneal incisions. The aim of this review is to discuss the history and the current status of clear corneal incision creation, the design and materials of surgical blades, and the current trends in manufacturing and sustainability. Although disposable instruments have some advantages and are very popular, recycling, if possible, and avoiding unnecessary plastic waste are important considerations. In any case, the step of CCI is a small one for the surgeon, but a big one for the eye. That is why it has to be done with the utmost precision and in-depth knowledge is important., (© 2023. The Author(s), under exclusive licence to The Royal College of Ophthalmologists.)

Background/aims: With a paradigm shift in geographic atrophy (GA) treatments now available, establishing consensus on the identification and diagnosis of the disease along with considerations for management of patients with GA will assist eye care professionals (ECP) in their day-to-day practices, leading to improved patient outcomes., Methods: A modified Delphi panel process (Geographic Atrophy Management Consensus) consisting of three total surveys and one virtual live meeting held between survey 2 and survey 3. Data were collected from July to October 2022. Participants included expert members of the eye care community that have demonstrated outstanding leadership among peers: a steering committee with three ECPs and a 15-member panel divided between five optometrists, five comprehensive ophthalmologists and five retina specialists. Consensus on statements related to the management of patients with GA was calculated using the RAND/UCLA Appropriateness Method., Results: At the conclusion of the third survey, consensus was reached on 91% of the 77 statements. Critical consensus topics include: (1) optical coherence tomography as the favoured method to diagnose and monitor GA, (2) preferred practice patterns regarding referral of patients to retina specialists and (3) treatment criteria given the advent of emerging therapeutics for GA., Conclusions: Generating awareness of early signs of disease development, progression and identifying the best tools to evaluate GA establishes ideal management and referral strategies. Given the paradigm shift in GA management driven by approved therapies, coupled with the fact that the disease is progressive resulting in devastating vision loss, these strategies are critical to ensure best overall outcomes., Competing Interests: Competing interests: PKK, CDR, YM, EY, TK, NK and MTD have served as consultants for IVERIC bio. CDR and MSI have received research support from IVERIC bio. JS and MRR have served on advisory boards for IVERIC bio., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Abstract: Ligneous conjunctivitis is a rare cause of chronic conjunctivitis that may be triggered by ocular insults such as trauma or infections. We present an interesting case of ligneous conjunctivitis caused by a viral infection that responded well to conservative management. Topical cyclosporine and heparin are a good treatment regimen that caused resolution of lesions and prevented recurrences., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: To compare patient preferences of postoperative cataract surgery topical medication use between a 1-drop and a 3-drop regimen., Setting: Two private cataract surgery centers., Design: Open-label randomized self-controlled prospective study., Methods: This study included 30 patients (60 eyes) undergoing routine cataract surgery in both eyes. In this contralateral eye study, 1 eye of each patient was randomized to the 1-drop regimen of intracameral delivery of moxifloxacin and dexamethasone suspension and topical bromfenac for 30 days. The other eye, randomized to the 3-drop regimen, received topical moxifloxacin 0.5% 4 times a day for 7 days and bromfenac 0.07% daily for 30 days postoperatively, along with prednisolone acetate 1% 4 times a day for 30 days. Patients reported their preferred regimen 2 weeks after the second surgery with a validated questionnaire. Secondary outcomes included subjective ocular pain, inflammation score, and out-of-pocket cost. Intraocular pressure (IOP) and macular thickness were also measured., Results: Of the 29 patients, 28 (96.6%) significantly more preferred the eye treated with a 1-drop regimen. Self-reported pain, activity interference, and out-of-pocket cost were significantly less in the 1-drop group. Inflammation and 1-day uncorrected distance visual acuity were also significantly better in the 1-drop group. Macular thickness and mean IOP were similar between groups., Conclusions: Intracameral delivery of steroid and antibiotics was preferred by most of the patients undergoing cataract surgery. These eyes had significantly less pain, inflammation, activity interference, and out-of-pocket cost and significantly better uncorrected distance visual acuity at 1 day postoperatively. IOP and macular thickness were similar between groups., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of ASCRS and ESCRS.)

Purpose: To compare pain and the need for the opioid fentanyl use associated with the administration of phenylephrine 1.0%-ketorolac 0.3% (P/K) with those of epinephrine administration during cataract surgery., Setting: Ambulatory surgery center., Design: Single-center, prospective, randomized, double-masked, self-controlled trial., Methods: Patients undergoing bilateral, topical anesthetic cataract surgery were randomized to receive either intracameral P/K or epinephrine in their balanced salt solution for the first eye and the other for the second eye, 2 weeks later. Fentanyl was used to manage intraoperative pain. The primary end point was the need for fentanyl administration intraoperatively. Secondary outcomes included pain measurements; surgery duration; effective phacoemulsification time; pupil size; and complications., Results: 112 eyes of 56 patients were enrolled. Significantly fewer eyes in the P/K group (7 [12.5%]) than in the epinephrine group (19 [33.9%]; P = .013) required intraoperative fentanyl administration. Mean pain scores were lower in the P/K group than those in the control group at all timepoints. For patients with no pain to mild pain (pain scores ≤ 3), 85.7% (n = 48) of the P/K group and 58.9% (n = 33) of the epinephrine group met this benchmark ( P = .003) intraoperatively. The combined outcome, the number of patients not receiving intravenous fentanyl and experiencing no pain to mild pain, was significantly higher in the study (82.1%, n = 46) than in the control group (58.9%, n = 33; P = .013)., Conclusions: P/K administration significantly reduced pain and the need for fentanyl use. Using P/K is a practical way for cataract surgeons to provide better patient care and reduce the need for intraoperative opioids., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of ASCRS and ESCRS.)

Postrefractive surgery ectasia is a serious, sight-threatening complication seen after the following procedures: laser in situ keratomileusis, photorefractive keratectomy, small-incision lenticule extraction, radial keratotomy, and/or arcuate keratotomy. Specific risk factors may include age, corneal thickness, degree of refractive error, corneal topographic changes including irregular astigmatism, percent tissue ablation, and residual stromal bed. Biomarkers may be a new option to help indicate who is at greatest risk for ectasia. Visual aids including spectacles or contacts lenses are often required to achieve optimal vision. Collagen crosslinking is the only treatment believed to stop progression of ectasia and prevent keratoplasty. Other surgical options may include topography-guided phototherapeutic keratectomy and intrastromal corneal ring segments. Ultimately, an "ounce of prevention is a pound of cure," so careful preoperative screening and ultimately offering the safest and most effective treatments for patients is arguably the most important job of the refractive surgeon., (Copyright © 2021 Published by Wolters Kluwer on behalf of ASCRS and ESCRS.)

Purpose: To evaluate the safety and efficacy of a nepafenac punctal plug delivery system (N-PPDS) after cataract surgery., Setting: Three U.S. clinical sites., Design: Prospective, multicenter, randomized (2:1), parallel-arm, double-masked, placebo-controlled, phase II pilot study., Methods: Fifty-six subjects (aged older than 22 years) with expected postcataract correctable distance vision of 20/30 or better and lower puncta allowing dilation up to 1.0 mm received either the nepafenac (N-PPDS group; n = 38 eyes) or a placebo punctal plug delivery system (p-PPDS group; n = 18 eyes). All eyes underwent routine unilateral cataract surgery with intraocular lens implantation. The primary and secondary efficacy measures were postoperative ocular pain and inflammation, respectively., Results: There were 38 patients in the experimental N-PPDS group and 18 patients in the control group. The N-PPDS group had a significantly higher percentage of pain-free patients than that in the p-PPDS group (22/32 [69%] vs 6/16 [38%] at 3 days, P = .038; and 24/36 [67%] vs 5/16 [31%] at 7 days, P = .018). A higher percentage of patients in the N-PPDS group (15/29 [52%] vs 0/14 [0%] in p-PPDS) was pain free at all visits (P = .001). Anterior chamber cell scores were better in the N-PPDS group (patients with no anterior chamber cells: 18/36 [50%] vs 3/16 [19%] in p-PPDS; P = .034) at 7 days. The plug retention rate was 98% (55/56) at 14 days. Adverse events having a suspected relationship with the punctal plug treatment occurred in 1 case of the N-PPDS group having to do with placement and zero in the p-PPDS group., Conclusions: The N-PPDS was safe and effective for the management of ocular pain and inflammation after cataract surgery., (Copyright © 2021 Published by Wolters Kluwer on behalf of ASCRS and ESCRS.)

Purpose: To assess 5-year effectiveness and safety of 2 iStent® trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) not controlled on 1 medication., Materials and Methods: This prospective, interventional, single-arm, multi-surgeon study (NCT #1252862, clinicaltrials.gov) enrolled eyes with OAG, preoperative intraocular pressure (IOP) of 18-30 mmHg on 1 ocular hypotensive medication, and 22-38 mmHg after medication washout. Eyes underwent standalone implantation of 2 iStent devices and were followed through 60 months postoperatively. Efficacy was quantified by mean diurnal IOP and medication usage. Efficacy endpoints included the proportion of eyes with ≥20% IOP reduction versus baseline unmedicated IOP (primary efficacy), and the proportion of eyes with IOP ≤18 mmHg (secondary efficacy) without medication or secondary glaucoma surgery. Safety parameters included visual acuity, cup-to-disc ratio, visual field, and complications and adverse events., Results: Preoperative mean IOP on 1 medication was 20.6 ± 2.0 mmHg and post-washout unmedicated IOP was 24.1 ± 1.4 mmHg (n = 39). At 5 years postoperative, medication-free mean diurnal IOP reduced to 14.5 ± 2.2 mmHg, constituting a 40% decrease versus preoperative washed-out IOP ( p < .0001). In addition, this 5-year medication-free IOP constituted a 30% decrease versus preoperative IOP on 1 medication ( p < .0001). At Month 60, 89.7% (26/29) of eyes achieved the primary efficacy endpoint of ≥20% IOP reduction versus baseline unmedicated IOP, and 86.2% (25/29) of eyes achieved the secondary efficacy endpoint of IOP ≤18 mmHg, without medication or secondary glaucoma surgery. Throughout follow-up, 89.7-91.3% of eyes were on no medications. Favorable safety included no secondary glaucoma surgeries, minimal adverse events, and stable visual acuity, cup-to-disc ratio, and visual fields through 5 years postoperative., Conclusions: This prospective interventional study demonstrates persistent 5-year reductions in IOP and freedom from medications, together with favorable safety, following implantation of 2 first-generation trabecular micro-bypass stents in eyes with OAG on 1 preoperative medication.

Aims: To assess the cost-effectiveness of corneal collagen cross-linking (CXL) versus no CXL for keratoconus in the United States (US)., Methods: A discrete-event microsimulation was developed to assess the cost-effectiveness of corneal cross-linking (CXL, Photrexa + KXL combination product) versus no CXL for patients with keratoconus. The lifetime model was conducted from a US payor perspective. The source for CXL efficacy and safety data was a 12-month randomized, open-label, sham-controlled, multi-center, pivotal trial comparing CXL versus no CXL. Other inputs were sourced from the literature. The primary outcome was the incremental cost per quality-adjusted life year gained. Costs (2019 USD) and effects were discounted 3% annually. The impacts of underlying uncertainty were evaluated by scenario, univariate, and probabilistic analyses., Results: Starting at a mean baseline age of 31 years and considering a mixed population consisting of 80% slow-progressors and 20% fast-progressors, the CXL group was 25.9% less likely to undergo penetrating keratoplasty (PK) and spent 27.9 fewer years in advanced disease stages. CXL was dominant with lower total direct medical costs (-$8,677; $30,994 versus $39,671) and more QALYs (1.88; 21.80 versus 19.93) compared to no CXL. Considering the impact of reduced productivity loss in an exploratory scenario, CXL was associated with a lifetime cost-savings of $43,759 per patient. CXL was cost-effective within 2 years and cost-saving within 4.5 years., Limitations: Limitations include those that are common to similar pharmacoeconomic models that rely on disparate sources for inputs and extrapolation on short-term outcomes to a long-term analytical horizon., Conclusions: Keratoconus is a progressive and life-altering disease with substantial clinical, economic, and humanistic consequences. The economic value of cross-linking is maximized when applied earlier in the disease process and/or younger age, and extends to improved work productivity, out-of-pocket costs, and quality of life.

Purpose: To evaluate long-term visual and astigmatic outcomes of sequential corneal crosslinking (CXL) followed by topography-guided photorefractive keratectomy (PRK)., Setting: Single-practice outpatient setting., Design: Retrospective case review., Methods: This is a single-surgeon retrospective case review of eyes with keratoconus undergoing sequential CXL and then topography-guided PRK. Change in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), topographic, refractive, and keratometric astigmatism was analyzed using power vector analyses at baseline, 6 months, and 12 months after topography-guided PRK. Changes in higher-order aberrations (HOAs), posterior astigmatism, spherical equivalent (SE), and central corneal thickness (CCT) were also analyzed. Correlations between age, time between CXL and PRK, sex, manifest SE, CCT, maximum and average keratometric values, and HOAs were evaluated for significance., Results: Of the 62 eyes studied, regardless of refractive treatment, topography-guided PRK following CXL in patients with keratoconus improved CDVA (mean 20/30; 2-line improvement) and UDVA (mean 20/50; 4-line improvement). Over 12 months, visual acuity continued to improve across all eyes treated (P < .001). Overall, there were significant improvements in corneal astigmatism, maximum keratometry, mean keratometry, SE, posterior astigmatism, and total HOAs. No significant correlations were found between age, sex, time elapsed between CXL and PRK, and age at the time of either procedure on final visual acuity., Conclusions: Results of this study reinforced previous findings that topography-guided PRK in previously cross-linked keratoconus eyes proves to be an efficacious and safe method for improving visual acuity and reducing irregular corneal astigmatism, with continued improvement.

Purpose: To evaluate terpinen-4-ol lid scrubs (Cliradex) with Microblepharoexfoliation (MBE) (BlephEx) in the treatment of Demodex blepharitis., Methods: An Institutional Review Board (IRB) approved the randomized prospective double-masked trial of 50 patients with Demodex positive blepharitis. All subjects were given an in-office MBE treatment and randomized to masked lid scrubs (terpinen-4-ol or sham) twice daily for 1 month. All subjects then returned for an additional MBE treatment and received open-label terpinen-4-ol scrubs twice daily for 1 month., Outcomes: Demodex levels, Ocular Surface Disease Index, tear osmolarity, MMP-9, Schirmer 1 and grading of the lid margin appearance, meibomian gland dropout, and meibomian gland secretions., Results: Forty-six subjects (23 per group) were included for the analysis; 4 lost to follow up. Total Demodex folliculorum levels in the Cliradex group improved: 4.7 to 3.6 (first month interval P = 0.266) to 2.6 (second month interval P = 0.279), overall P < 0.05 over 2 months. Total levels in the sham group improved: 5.1 to 3.0 (first month interval P < 0.05) to 2.5 (second month interval P = 0.496), overall P < 0.05 over 2 months. No clear statistically meaningful improvements in other dry eye and blepharitis data metrics were observed., Conclusions: In-office MBE treatments combined with either Cliradex terpinen-4-ol medicated lid scrubs or sham scrubs showed a statistically significant reduction in D. folliculorum infestation levels; however, conclusions on clinical significance could not be made. In-office MBE with terpinen-4-ol lid scrubs showed no significant improvement over sham scrubs.

Purpose: To compare the visual and refractive outcomes with a diffractive toric extended depth-of-focus (EDOF) intraocular lens (IOL) when both eyes are targeted for emmetropia and the nondominant eye is targeted for slight myopia., Setting: Three clinical practices, United States., Design: Prospective case series., Methods: Patients having routine cataract surgery with bilateral Tecnis Symfony toric EDOF IOL implantation were assigned to 1 of 2 groups. In 1 group, the nondominant eye was targeted for -0.50 diopter (D) (mini-monovision). Assessments included uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (4 m), intermediate (66 cm), and near (40 cm) and the postoperative residual refractive error., Results: Forty patients were enrolled in each group, with 1 dropout. The mean postoperative residual refractive astigmatism was 0.25 D in both groups, with no statistically significant difference. The mean residual refractive astigmatism was 0.50 D or lower in 92% of eyes (72/78) in the mini-monovision group and 95% of eyes (74/78) in the emmetropia group 3 months postoperatively. The mini-monovision group had slightly worse uncorrected visual acuity at 4 m than the emmetropia group (0.16 versus 0.09; P = .002) but better uncorrected acuity at 40 cm (0.25 versus 0.34; P < .001). Binocular uncorrected acuity was not statistically significantly different between groups at 4 m (-0.03 versus -0.01; P = .33) or 66 cm (0.06 versus 0.04; P = .34) but was statistically significant at 40 cm (0.25 versus 0.19; P = .03)., Conclusions: The EDOF toric IOL provided functional distance, intermediate, and near vision. A slight monovision approach appears to improve near visual acuity., (Copyright © 2019. Published by Elsevier Inc.)

Purpose: Characterize the safety and tolerability of lifitegrast ophthalmic solution 5.0% for the treatment of dry eye disease., Methods: Pooled data from five randomized controlled trials were analyzed. Key inclusion criteria were adults with dry eye disease (Schirmer tear test score ⩾1 and ⩽10 mm, eye dryness score ⩾40 (visual analog scale 0-100), corneal staining score ⩾2.0 (0-4 scale)). Participants were randomized to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 84 or 360 days. Treatment-emergent adverse events and drop comfort scores were assessed., Results: Overall, 2464 participants (lifitegrast, n = 1287; placebo, n = 1177) were included. Ocular treatment-emergent adverse events occurring in >5% in either group were instillation site irritation (lifitegrast, 15.2%; placebo, 2.8%), instillation site reaction (lifitegrast, 12.3%; placebo, 2.3%), and instillation site pain (lifitegrast, 9.8%; placebo, 2.1%); the most common (> 5%) nonocular treatment-emergent adverse event was dysgeusia (lifitegrast, 14.5%; placebo, 0.3%). The majority of treatment-emergent adverse events were mild to moderate in severity. Discontinuation due to treatment-emergent adverse events occurred in 7.0% (lifitegrast) versus 2.6% (placebo) of participants (ocular: 5.5% vs 1.5%; nonocular: 1.9% vs 1.1%). Drop comfort scores with lifitegrast improved within 3 min of instillation and the score at 3 min improved across visits (12-week trials (both eyes, day 84 vs 0): 2.0 vs 3.3; SONATA (day 360 vs 0): right eye, 1.2 vs 1.7; left eye, 1.2 vs 1.8)., Conclusion: Lifitegrast ophthalmic solution 5.0% appeared to be safe and well tolerated for the treatment of dry eye disease. Drop comfort with lifitegrast improved within 3 min of instillation.

Dry eye is a common condition that is treated primarily by topical lubricants, immunomodulation, and a variety of punctal and canalicular plugs (occluders). Biofilm formation has been reported as an ongoing problem with the clinical use of occluders. In order to explore the role of biofilm formation on occluders, we tested the bacteria strain, Staphylococcus aureus , with three different types of occluders, Delta R , Odyssey R , and Alphamed R . Scanning electron microscopy (SEM) of these occluders revealed a variation in surface appearance, with Odyssey R being the smoothest (but with grooves), followed by Delta R , and Alphamed R . Exposing each type of occluder to dynamically grown bacterial cultures of S. aureus , a ~3 fold statistically significant difference in bacteria colonization between the Odyssey R and Alphamed R occluder and a ~2 fold higher trend between Odyssey R and Delta R were detected. These quantitative results were also verified with SEM, showing extensive S. aureus colonization and biofilm formation on the surface of the Odyssey R occluder. The results also indicate that bacterial colonization readily occurs on all three types of occluders. The occluder with the smoothest but grooved surface (Odyssey R ), displayed increased biofilm formation when compared to those with rougher surfaces.

Purpose: To present a case of microsporidial keratitis in a femtosecond laser-created astigmatic keratotomy (AK) incision., Methods: Case report., Results: A 65-year-old Middle Eastern man presented 2 months after uncomplicated femtosecond laser-assisted cataract surgery (FLACS) and AK with mildly decreased vision and corneal edema in the operative eye. Shortly after treatment with topical corticosteroids, a fulminant corneal infiltrate manifested along the temporal arcuate incision. Multiple corneal scrapings sent for laboratory analysis were inconclusive. Two weeks after the initial presentation, a deep tissue sample was obtained using a 27-gauge cannula passed within the arcuate incision. The gram stain was directly observed, revealing intracellular microsporidial spores. The patient was treated with oral albendazole 400 mg once daily over 2 weeks and topical voriconazole 1% and fumagillin 3 mg/mL eye drops over 10 weeks. During this course, visual function steadily recovered as the infiltrate coalesced and ocular inflammation subsided., Conclusions: This is the first reported case of microsporidial keratitis presenting as a late-onset infection after femtosecond laser-assisted AK.

Purpose: To compare the safety and efficacy of IBI-10090 anterior chamber intracameral dexamethasone drug-delivery suspension (Dexycu) with those of prednisolone acetate 1.0% ophthalmic drops in treating inflammation after cataract surgery., Setting: Eleven centers in the United States., Design: Prospective randomized open-label multicenter trial., Methods: Patients were randomized 2:1 to receive a 5 μL injection of 517 μg IBI-10090 in the anterior eye chamber or topical prednisolone 1.0% drops (1 drop 4 times daily for 3 weeks). The postoperative follow-up was 90 days. The primary outcome was safety, evaluated by the incidence and severity of adverse events. Exploratory measures were anterior chamber cell, anterior chamber flare, and anterior chamber cell-flare clearing., Results: One hundred twenty-six IBI-10090 patients and 55 prednisolone patients were included in the safety analysis. Two serious adverse events unrelated to treatment were reported. The decrease in endothelial cell density was not significantly different between groups. The most common adverse events were increased intraocular pressure (11.1%), iritis (6.3%), and systemic (7.9% IBI-10090 group; 10.9% prednisolone group). By 8 days postoperatively, 51.6% of IBI-10090 eyes and 50.9% of prednisolone eyes had anterior chamber cell clearing; more than 98% of eyes had clearing at 90 days. The anterior chamber flare and anterior chamber cell-flare clearing results were similar. Of IBI-10090 patients, 68.7% strongly agreed that not having to use eyedrops was very convenient; 39.2% using prednisolone 1.0% strongly stated they would have preferred dropless therapy., Conclusion: The safety and efficacy of IBI-10090 and prednisolone 1.0% were similar, with IBI-10090 preferred over drops., (Copyright © 2018 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate a sequential treatment algorithm for visual and keratometric improvement in keratoconus patients after corneal crosslinking (CXL) followed by topography-guided photorefractive keratectomy (PRK)., Setting: Ophthalmic Consultants of Long Island, Garden City, New York, USA., Design: Retrospective case series., Methods: This study reviewed patients with keratoconus who had CXL followed by custom topography-guided PRK between April 2016 and December 2016. The following data were collected at baseline, the time of CXL, and 3 months and 6 months after PRK: uncorrected (UDVA) and corrected (CDVA) distance visual acuities, keratometric astigmatism, spherical equivalent, maximum and mean keratometry readings, and corneal thickness at the cone apex. Demographic data, age at time of CXL and PRK, and time elapsed between CXL and PRK were analyzed for significance and a correlation with visual and astigmatic outcomes., Results: The study comprised 56 patients (62 eyes), 34 who had both topographic and refractive treatment and 28 patients who had treatment of topographic irregularities only. The mean age was 38.08 years ± 13.07 (SD) at CXL and 40.33 ± 13.44 years at topography-guided PRK. Six months after PRK, there was a significant improvement in UDVA and CDVA in the refractive group (20/60 and 20/30, respectively) versus the nonrefractive group (20/100 and 20/40, respectively). Ninety-three percent of eyes that had refractive treatment had 20/40 or better CDVA. There were no significant adverse events in any case., Conclusions: The data support the use of refractive treatment in addition to topographic treatment for visual improvement in patients with keratoconus having CXL and PRK., (Copyright © 2018 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Introduction: Dry eye disease (DED) is a common ocular disorder that can have a substantial burden on quality of life and daily activities. Lifitegrast ophthalmic solution 5.0% is the first medication approved in the US for the treatment of the signs and symptoms of DED. The aim of this article is to summarize the preclinical and clinical data on lifitegrast and discuss how lifitegrast may fit into the current treatment landscape for DED. Areas covered: A literature search of published preclinical and clinical data was conducted to review the chemistry, pharmacodynamics, pharmacokinetics, and clinical efficacy/safety of lifitegrast. The impact that lifitegrast may have on DED treatment practices is also discussed. Expert opinion: The introduction of lifitegrast provides a potentially important additional option for eye care professionals treating DED. In clinical trials conducted in adults with DED, lifitegrast ophthalmic solution 5.0% improved both signs and symptoms of DED. Of note, in 2 phase 3 trials, symptom improvements were observed as early as 2 weeks, which may be explained by lifitegrast's unique mechanism of action of blocking a specific signaling pathway in inflammation. Future research should include evaluation of whether lifitegrast can be used in combination with other DED treatments.

Purpose: Dry eye disease is a multifactorial disease with numerous well-documented risk factors. However, to date, sleep position has not been associated with this condition. After observing patients in our practice, we believe that the sleep position in some cases may significantly affect dry eye and meibomian gland dysfunction (MGD)., Methods: This is a single-centered, cross-sectional, noninterventional, institutional review board-approved, single-masked, nonrandomized study of 100 patients whose complaints were related to dry eye disease and a control group of 25 age-matched asymptomatic patients. Two questionnaires were used: one to analyze patients' sleep habits and the other to assess patients' Ocular Surface Disease Index. Dry eye severity was graded based on the MGD stage, fluorescein corneal staining and lissamine green staining, Schirmer 1 testing, tear osmolarity levels, and clinical examination., Results: A statistically significant difference was shown with back sleeping compared with left side sleeping using lissamine green staining (analysis of variance, P = 0.005). The Ocular Surface Disease Index score was also found to be elevated in patients who slept on their right or left side (36.4 and 34.1, respectively) as opposed to back sleepers (26.7) with P < 0.05. There was no statistically significant correlation found between the sleep position and degree of MGD., Conclusions: In addition to current treatment, patients who sleep on their side or face down might see a reduction in dry eye and MGD if they change their sleep pattern to the supine position.

Purpose: To evaluate the study drug OMS302 (Omidria [phenylephrine and ketorolac injection 1.0%/0.3%]) compared with a balanced salt solution (vehicle), ketorolac, and phenylephrine on pupil diameter during cataract surgery and early postoperative ocular pain., Setting: Twenty-three centers in the United States., Design: Randomized clinical trial., Methods: Patients were randomized (1:1:1:1) to receive vehicle, phenylephrine, ketorolac, or the study drug containing phenylephrine and ketorolac administered intracamerally during surgery. Intraoperative pupil diameter was determined each minute by video capture. Postoperative ocular pain was evaluated for up to 12 hours., Results: The study evaluated 223 patients. The study drug was significantly better than the vehicle and ketorolac in maintaining mydriasis (least-squares mean differences 0.9 ± 0.1 [SEM] and 0.7 ± 0.1 for the study drug versus vehicle and ketorolac, respectively; P < .0001 each). Ocular pain assessed using the Visual Analog Scale was significantly reduced for the study drug compared with the vehicle or phenylephrine (least-squares mean difference -4.6 ± 2.2 and P = .042 and 5.9 ± 2.2 and P = .009, respectively). Significantly fewer patients treated with the study drug (3 [6.1%]) had an intraoperative pupil diameter smaller than 6.0 mm compared with those treated with the vehicle (25 [47.2%]; P < .0001), ketorolac (18 [34.6%]; P = .0004), or phenylephrine (11 [22.4%]; P = .0216)., Conclusions: The study drug was safe and efficacious in maintaining mydriasis and reducing postoperative ocular pain. Both ketorolac and phenylephrine contributed to the therapeutic effects, with the combination showing superiority to either agent alone in maintaining an intraoperative pupil diameter of 6.0 mm or larger., (Copyright © 2017 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To assess the effect of oral re-esterified omega-3 fatty acids on tear osmolarity, matrix metalloproteinase-9 (MMP-9), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), fluorescein corneal staining, Schirmer score, meibomian gland dysfunction (MGD) stage and omega-3 index in subjects with dry eyes and confirmed MGD., Methods: This was a multicenter, prospective, interventional, placebo-controlled, double-masked study. Subjects were randomized to receive 4 softgels containing a total of 1680 mg of eicosapentaenoic acid/560 mg of docosahexaenoic acid or a control of 3136 mg of linoleic acid, daily for 12 weeks. Subjects were measured at baseline, week 6, and week 12 for tear osmolarity, TBUT, OSDI, fluorescein corneal staining, and Schirmer test with anesthesia. MMP-9 testing and omega-3 index were done at baseline and at 12 weeks., Results: One hundred five subjects completed the study. They were randomized to omega-3 (n = 54) and control group (n = 51). Statistically significant reduction in tear osmolarity was observed in the omega-3 group versus control group at week 6 (-16.8 ± 2.6 vs. -9.0 ± 2.7 mOsm/L, P = 0.042) and week 12 (-19.4 ± 2.7 vs. -8.3 ± 2.8 mOsm/L, P = 0.004). At 12 weeks, a statistically significant increase in omega-3 index levels (P < 0.001) and TBUT (3.5 ± 0.5 s vs. 1.2 ± 0.5 s, P = 0.002) was also observed. Omega-3 group experienced a significant reduction in MMP-9 positivity versus control group (67.9% vs. 35.0%, P = 0.024) and OSDI scores decreased significantly in omega-3 (-17.0 ± 2.6) versus control group (-5.0 ± 2.7, P = 0.002)., Conclusions: Oral consumption of re-esterified omega-3 fatty acids is associated with statistically significant improvement in tear osmolarity, omega-3 index levels, TBUT, MMP-9, and OSDI symptom scores.

Unlabelled: Laser in situ keratomileusis (LASIK) articles published between 2008 and 2015 that contain clinical outcomes data were reviewed and graded for quality, impression, and potential bias. All 97 relevant articles (representing 67 893 eyes) provided a positive or neutral impression of LASIK. Industry bias was not evident. The aggregate loss of 2 or more lines of corrected distance visual acuity was 0.61% (359/58 653). The overall percentage of eyes with uncorrected distance visual acuity better than 20/40 was 99.5% (59 503/59 825). The spherical equivalent refraction was within ±1.0 diopter (D) of the target refraction in 98.6% (59 476/60 329) of eyes, with 90.9% (59 954/65 974) within ±0.5 D. In studies reporting patient satisfaction, 1.2% (129/9726) of patients were dissatisfied with LASIK. Aggregate outcomes appear better than those reported in summaries of the safety and effectiveness of earlier laser refractive surgery systems approved by the U.S. Food and Drug Administration. Modern results support the safety, efficacy, and patient satisfaction of the procedure., Financial Disclosure: Proprietary or commercial disclosures are listed after the references., (Copyright © 2016 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To determine the relationship between untoward events noted during phacoemulsification surgery associated with aberrant infusion misdirection and their causal relationship to current infusion sleeve design., Setting: The New York Eye & Ear Infirmary of Mt. Sinai, New York, New York, USA., Design: Retrospective case reports and experimental study., Methods: Observations of live cataract surgery were documented with high-definition videography using 3 commercial phacoemulsification platforms. Laboratory studies using a Photron MC2 high-speed camera and the Kitaro cataract surgical system were used to simulate surgical maneuvers and assess flow patterns and visualize the dynamics of fluid movement in the anterior chamber. Color-flow Doppler ultrasound studies were used to demonstrate the effect of infusion fluid on the iris during surgery., Results: Misdirected infusion and floppy-iris leaflets were determined to be secondary to a fulcrum effect at the corneal wound that constrained movement of the standard silicone sleeves. The phacoemulsification needles could therefore decenter independently of the infusion sleeve, attenuating infusion volume down 1 side of the sleeve and, as a result, obstructing fluid exiting the ipsilateral port., Conclusions: Untoward events associated with aberrant fluid infusion during phacoemulsification surgery were secondary to a fulcrum effect at the corneal wound. Complications included misdirected infusion that facilitated the transport of retained nuclear fragments to the vitreous, inconsistent lens followability during phacoemulsification, and exaggerated movements of the iris particularly consistent with intraoperative floppy-iris syndrome and pseudoexfoliation., Financial Disclosure: None of the authors has a financial or proprietary interest in any material or method mentioned., (Copyright © 2016 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the 1-year safety of lifitegrast ophthalmic solution 5.0% in patients with dry eye disease compared with placebo., Methods: SONATA (Safety Of a 5.0% coNcentrATion of lifitegrAst ophthalmic solution) was a multicenter, randomized, prospective, double-masked, placebo-controlled phase 3 study (NCT01636206). Adults (≥18 years) with dry eye disease (Schirmer test score ≥1 and ≤10 mm; corneal staining score ≥2.0) were randomized 2:1 to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 360 days. The primary objective was percentage and severity of treatment-emergent adverse events (TEAEs). Secondary objectives were ocular safety measures: corneal fluorescein staining, drop comfort, best-corrected visual acuity, slit-lamp biomicroscopy, and intraocular pressure over 7 visits. Exploratory objectives included concentration of lifitegrast in plasma., Results: The safety population comprised 331 participants (220 lifitegrast; 111 placebo). There were no serious ocular TEAEs. Overall, 53.6% of participants receiving lifitegrast experienced ≥1 ocular TEAE versus 34.2% in the placebo group; most TEAEs were mild to moderate in severity. Rates of discontinuation because of TEAEs were 12.3% (lifitegrast) versus 9.0% (placebo). The most common (>5%) TEAEs occurring in either treatment group were instillation site irritation (burning), instillation site reaction, visual acuity reduced, dry eye, and dysgeusia (change in taste). Ocular safety parameters for lifitegrast were similar to placebo. The mean plasma lifitegrast concentration at 360 days (n = 43) was below the limit of detection. There was no indication of systemic toxicity or localized infectious complications secondary to chronic immunosuppression., Conclusions: Lifitegrast ophthalmic solution 5.0% seemed safe and well tolerated in this study, with no unexpected adverse events.

The femtosecond laser is a new and developing technology for cataract surgery. This technology is approved for the capulotomy, primary incisions, astigmatic incisions, and lens fragmentation. The femtosecond laser has the potential to offer significant advantages over current phacoemulification and will be the standard method of cataract extraction in ten years., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Unlabelled: Corneal ectasia is a progressive, degenerative, and noninflammatory thinning disorder of the cornea. Recently developed corneal reshaping techniques have expanded the treatment armamentarium available to the corneal specialist by offering effective nontransplant options. This review summarizes the current evidence base for corneal collagen crosslinking, topography-guided photorefractive keratectomy, and intrastromal corneal ring segment implantation for the treatment of corneal ectasia by analyzing the data published between the years 2000 and 2014., Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned., (Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)