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Majid Moshirfar,1– 3 Chap-Kay Lau,4 Nicholas A Chartrand,4 Mark T Parsons,4 Seth Stapley,5 Nour Bundogji,2 Yasmyne C Ronquillo,1 Steven H Linn,1 Phillip C Hoopes1 1Hoopes Vision Research Center, Hoopes Vision, Draper, UT, USA; 2John A. Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT, USA; 3Utah Lions Eye Bank, Murray, UT, USA; 4University of Arizona, College of Medicine-Phoenix, Phoenix, AZ, USA; 5Arizona College of Osteopathic Medicine, Midwestern University, Glendale, AZ, USACorrespondence: Majid Moshirfar, Medical Director Hoopes Vision Research Center, Hoopes Vision Research Center, 11820 S. State St. #200, Draper, UT, 84020, USA, Tel +1 801-568-0200, Fax +1 801-563-0200, Email cornea2020@me.comPurpose: To evaluate 10 years of KAMRA corneal inlay explantation and associated visual outcomes.Patients and Methods: Single-site retrospective chart review of 22 cases of AcuFocus KAMRA Inlay (ACI7000PDT) explantation (range 1 week– 1 year). Uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA), and manifest refraction at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year post-explantation were reviewed.Results: The explantation rate was 8.2% across 10 years. All patients underwent KAMRA explantation due to dissatisfaction with their vision including blurry near vision, impaired night vision, decreased vision in dim lighting, streaks or halos, haze, and double vision. Mean UDVA pre-implant was − 0.01± 0.13 logMAR (logarithm of the minimal angle of resolution), 0.30± 0.22 logMAR pre-explant, and 0.16± 0.15 logMAR post-explant (n=20). Mean UNVA pre-implant was 0.37± 0.09 logMAR, 0.38± 0.13 logMAR pre-explant, and 0.42± 0.21 logMAR post-explant (n=20). Mean CDVA pre-implant was − 0.01± 0.04 logMAR and 0.05± 0.11 logMAR post-explant (n=17). Mean CDVA pre-explant was 0.04± 0.07 logMAR and 0.04± 0.11 logMAR post-explant (n=19). Significant differences were observed between pre-implant and post-explant UDVA (p=0.009), and between pre-explant and post-explant UDVA (p=0.02). All patients (100%) had 20/20 or better CDVA pre-implant but decreased to 73.7% post-explant. Sixty percent (12/20) of the patients lost UDVA Snellen acuity lines post-explant. MRSE was − 0.31± 0.29 D pre-implant and +0.26± 0.77 D post-explant (p=0.007) with note of a hyperopic shift. The hyperopic shift in 31.6% (6/19) of patients did not resolve after explantation. Post-explant residual corneal haze occurred in 72.7% (16/22) of patients.Conclusion: Although the KAMRA corneal inlay is a removable device, patients may experience residual corneal haze, hyperopic shift, and deficits in UDVA after explantation compared to pre-implantation UDVA.Keywords: presbyopia, cornea, small aperture inlay, KAMRA, explantation

Majid Moshirfar,1– 3 Marshall K Henrie,4 Carter J Payne,5 Briana K Ply,1 Yasmyne C Ronquillo,1 Steven H Linn,1 Phillip C Hoopes1 1HDR Research Center, Hoopes Vision, Draper, UT, USA; 2John A. Moran Eye Center, Department of Ophthalmology and Visual Sciences, University of Utah School of Medicine, Salt Lake City, UT, USA; 3Utah Lions Eye Bank, Murray, UT, USA; 4University of Utah School of Medicine, Salt Lake City, UT, USA; 5Case Western Reserve University School of Medicine, Cleveland, OH, USACorrespondence: Majid Moshirfar, HDR Research Center, Hoopes Vision, 11820 State St, Draper, UT, USA, Email cornea2020@icloud.comAbstract: Presbyopia may represent the largest segment of refractive errors that is without an established and effective refractive surgery treatment. Corneal Inlays are materials (synthetic or allogenic) implanted in the stroma of patients’ corneas to improve presbyopia. These inlays, introduced into the United States in 2015 via the small-aperture corneal inlay (KAMRATM, SightLife Surgical/CorneaGen, Seattle, Washington, United States), were met with an initial wave of enthusiasm. Subsequent models like the shape-changing corneal inlay (RAINDROPTM, Revision Optics, Lake Forest, California, United States) offered excellent results for patients, but longer-term research raised questions about patient safety. At the time of this article, no synthetic corneal inlays are available in the United States for the correction of presbyopia. Other options for presbyopia correction include allograft corneal inlays, trifocal synthetic corneal inlays, pharmacologic therapies, scleral incisions or additive techniques and PresbyLASIK. Presently, allograft inlays consist of corneal lenticules removed from patients undergoing Small Incision Lenticule Extraction (SMILE). We will review corneal inlays and other alternative procedures that may provide effective and predictable treatments for patients with presbyopia.Keywords: corneal inlay, corneal onlay, SMILE, PEARL, PresbyLASIK, refractive surgery, KAMRA, raindrop, flexivue, corneal allografts, presbyopic allogenic refractive lenticule

Small aperture optics work by blocking unfocused peripheral light rays while allowing central light rays to focus on the retina. This pinhole effect creates an extended depth of focus and has been used in presbyopia correction, improving intermediate and near vision without markedly affecting distance vision. Another beneficial effect of small aperture optics is reducing aberrations caused by irregular corneas or irregular pupils. The first small aperture surgical device was the Kamra corneal inlay used on the nondominant eyes of presbyopic emmetropes. The pinhole concept was also adapted into the IC-8 intraocular lens (IOL) for presbyopia correction during cataract surgery and by the XtraFocus piggyback device to lessen unwanted aberrations in eyes with irregular corneas or pupils. The IC-8 IOL can be placed monocularly or binocularly with mini-monovision for further near vision improvement. The XtraFocus piggyback device can be placed either in the sulcus or capsular bag. The aim of this literature review is to synthesize evidence on the efficacy, safety, and patient-reported outcomes on surgical devices utilizing small aperture optics. A comprehensive search on PubMed was conducted with the keywords "small aperture optics," "small aperture corneal inlay," "small aperture IOL," "Kamra corneal inlay," "IC-8 IOL," and "XtraFocus." In this review, we describe the progression of small aperture surgical devices, patient criteria, visual outcomes, complications, satisfaction, and recommendations for surgical success. [ABSTRACT FROM AUTHOR]

Majid Moshirfar,1,2 Jordan D Desautels,1,3 Brian D Walker,4 Orry C Birdsong,1 David F Skanchy,4 Tyler S Quist,5 Michael S Murri,6 Steve H Linn,1 Phillip C Hoopes Jr,1,2 Phillip C Hoopes1,2 1Hoopes, Durrie, Rivera Research Center, Hoopes Vision, Draper, UT, USA; 2John A. Moran Eye Center, Department of Ophthalmology and Visual Sciences, School of Medicine, University of Utah, Salt Lake City, UT, USA; 3The Warren Alpert Medical School, Brown University, Providence, RI, USA; 4McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA; 5Department of Ophthalmology and Visual Sciences, Carver College of Medicine, University of Iowa, Iowa City, IA, USA; 6Baylor College of Medicine, Houston, TX, USA Purpose: To assess longitudinal refractive, keratometric, and topographic changes following KAMRA small-aperture inlay implantation.Design and setting: Prospective study at a single site refractive surgery center.Methods: Fifty patients underwent KAMRA small-aperture corneal inlay implantation for the correction of presbyopia. Uncorrected near visual acuity (UNVA), uncorrected distance visual acuity, manifest refractive spherical equivalent (MRSE), mean keratometry (Km), corneal topography, and surgically induced astigmatism vector analysis assessments were performed preoperatively and at 1, 3, 6, 12, 24, and 36 months postoperatively.Results: The study comprises 50 eyes. An average shift of 0.15±0.63 D (range -1.63 to 2.00 D) occurred between preoperative baseline and 36 months. At 36 months, 54% of patients had hyperopic MRSE and 40% had myopic MRSE compared with baseline. Km was significantly elevated at all postoperative measurements compared with baseline, with the largest Km measured at 12 months. Eighty-six percent of patients had UNVA of 20/32 or better and 88% uncorrected distance visual acuity of 20/25 or better at 36 months. Longitudinal corneal topography revealed a pattern of corneal steepening over the body of the inlay and flattening over the aperture, correlating with a hyperopic shift. There was no significant surgically induced astigmatism.Conclusion: KAMRA inlay may cause an increase in Km compared with baseline. Corneal steepening may occur in a specific pattern with steepening over the inlay and flattening over the aperture. This topographic pattern causes a hyperopic shift, which may be relevant for subsequent procedures, such as cataract extraction. Keywords: presbyopia, KAMRA, wound healing, IOL calculation

AIM: To provide a side-by-side analysis of the summary of safety and effectiveness data (SSED) submitted to the FDA for the KAMRA and Raindrop corneal inlays for the correction of presbyopia. METHODS: SSED reports submitted to the FDA for KAMRA and Raindrop were compared with respect to loss of corrected distance visual acuity (CDVA), adverse event rates, induction of astigmatism, retention of contrast sensitivity, stability of manifest refractive spherical equivalent (MRSE), and achieved monocular uncorrected near visual acuity (UNVA) at 24mo. RESULTS: Totally 442/508 of KAMRA patients and 344/373 Raindrop patients remained enrolled in the clinical trials at 24mo. The proportion of KAMRA and Raindrop patients who lost ≥2 lines of CDVA at 24mo was 3.4% and 1%, respectively. The adverse event rate was comparable between the devices. No significant inductions of astigmatism were noted. Both technologies induced a transient myopic shift in MRSE followed by a hyperopic shift and subsequent stabilization. Totally 87% of KAMRA and 98% of Raindrop patients attained a monocular UNVA of J5 (20/40) or better at 24mo, 28% of KAMRA and 67% of Raindrop patients attained a monocular UNVA of J1 (20/20) or better at 24mo. CONCLUSION: Both devices can be considered safe and effective, however, the results of corneal inlay implantation are mixed, and long-term patient satisfaction will likely depend on subjective expectations about the capabilities of the inlays. Variability in surgical technique and postoperative care within and between the two clinical trials diminishes the comparative power of this article.

PURPOSE: The aim of the study is to evaluate patients' satisfaction and subjective vision 12 months after monocular KAMRA corneal inlay implantation for the surgical compensation of presbyopia. SUBJECTS AND METHODS: Medical records of patients who underwent corneal inlay implantation in the nondominant eye between 2013 and 2014 were retrospectively reviewed. Data were collected from several centers in Lebanon. Patients with hyperopia or myopia with presbyopia between 45 and 70 years not suffering from any other ocular pathology were eligible for inclusion. Twelve-month postoperative satisfaction score was evaluated in all patients as well as the subjective vision score for near, intermediate, and distant tasks. RESULTS: This study included 73 patients. Almost 95% (69/73) of patients were satisfied or very satisfied with their vision and 93% (68/73) never or almost never used reading glasses while performing daily tasks. Subjective vision scores were found to be higher for distant and intermediate tasks performed during the day than for those performed during the night (P< 0.001). The average subjective vision score for reading a book or a newspaper in dim light was the lowest among all average subjective vision scores. No difference in satisfaction was found between patients with myopia or hyperopia or between males and females. CONCLUSION: The implant of a small-aperture corneal inlay resulted in a substantial improvement in patients' distant, intermediate, and near subjective vision, better in normal light than in dim light, and most patients became spectacles independent. [ABSTRACT FROM AUTHOR]

Majid Moshirfar,1,2 Ryan T Wallace,3 David F Skanchy,4 Jordan D Desautels,5 Steven H Linn,1 Phillip C Hoopes Jr,1 Daniel S Durrie1,6 1Hoopes, Durrie, Rivera, Research Center, Hoopes Vision, Draper, UT, 2Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT, 3Brigham Young University, Provo, UT, 4McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, 5Tufts University School of Medicine, Boston, MA, 6Durrie Vision, Overland Park, KS, USA Purpose: To report the short-term results of simultaneous photorefractive keratectomy (PRK) and small-aperture cornea inlay implantation (KAMRA) surgery in treating presbyopia. Methods: Simultaneous PRK and KAMRA inlay surgery was performed on 21 patients from July 2015 to March 2016. Follow-up exams were conducted at 1, 3, and 6 months postoperatively. Our patients were also divided preoperatively into three categories: myopic, hyperopic, and emmetropic. Over the 6-month period, the main outcome measures were uncorrected near visual acuity (UNVA), changes in best-corrected distance visual acuity, and mean spherical equivalent refraction. Results: At 6-month follow-up, 83% (10/12) of patients had a monocular UNVA of 20/40 or better, and 75% had a binocular UNVA of 20/40 (J5) or better. At 6 months, the overall mean refractive spherical equivalent (MRSE) was -0.60 D (±0.42 standard deviation [SD], range: -1.38 to -0.13) with a mean change of -0.43 D (±1.19 SD, range: -1.5 to 2.63) compared to preoperative data. Overall, 91% (10/11) of patients were within a ±0.5 D range of our target -0.75 D for KAMRA use. One-hundred percent (5/5) of the hyperopes, 50% (1/2) of emmetropes, and 100% (4/4) of myopes met the targeted range. At 6 months, the MRSE for the hyperopic subgroup (n=5) was 0.33 D (±0.20 SD), the MRSE for the emmetropic subgroup (n=2) was -1.19 D (±0.19 SD), and the MRSE for the myopic subgroup (n=4) was -0.66 D (±0.36 SD). Conclusion: Based on preliminary results and a small sample size, it seems that simultaneous PRK and KAMRA is effective and predictable. There are multiple advantages in performing simultaneous PRK and KAMRA including a shorter recovery time and less steroid use than the two surgeries performed separately. Keywords: KAMRA, PRKamra, PRK, femptosecond, corneal, presbyopia

Majid Moshirfar,1,2 Tyler S Quist,3 David F Skanchy,4 Ryan T Wallace,5 Steven H Linn,1 Phillip C Hoopes Jr1 1Hoopes, Durrie, Rivera Research Center, Hoopes Vision, Draper, 2Department of Ophthalmology and Visual Sciences, John A Moran Eye Center, University of Utah School of Medicine, Salt Lake City, 3University of Utah School of Medicine, Salt Lake City, UT, 4McGovern Medical School, The University of Texas Health Science Center at Houston, TX, 5Brigham Young University, Provo, UT, USA Objective: The objective of this study was to describe 6-month postoperative efficacy and safety outcomes after monocular KAMRA corneal inlay implantation in emmetropic presbyopic patients. Study design: This study followed a retrospective chart analysis. Setting: This study was performed at Hoopes Vision in Draper, UT, USA. Subjects and methods: Fifty-seven patients met the inclusion criteria of this study and underwent KAMRA corneal inlay implantation following the approval of the United States Food and Drug Association between May 2015 and April 2016 at a single site. Surgery involved femtosecond laser-created corneal pockets of various depths. Efficacy, safety, and patient satisfaction reports were analyzed at 3 and 6 months. Results: At 6 months follow-up, the monocular uncorrected near visual acuity (UNVA) was Jaeger (J) 4 (20/32), the mean uncorrected distance visual acuity was 20/25, and the mean corrected distance visual acuity was 20/20. At 6 months, 71% of patients with a pocket depth of ≥250 µm had a UNVA of 20/20 or better, whereas only 22% of patients with a shallow pocket depth of

Shehzad Anjam Naroo, Paramdeep Singh Bilkhu Ophthalmic Research Group, School of Life & Health Sciences, Aston University, Birmingham, UK Abstract: The treatment of presbyopia has been the focus of much scientific and clinical research over recent years, not least due to an increasingly aging population but also the desire for spectacle independence. Many lens and nonlens-based approaches have been investigated, and with advances in biomaterials and improved surgical methods, removable corneal inlays have been developed. One such development is the KAMRA™ inlay where a small entrance pupil is exploited to create a pinhole-type effect that increases the depth of focus and enables improvement in near visual acuity. Short- and long-term clinical studies have all reported significant improvement in near and intermediate vision compared to preoperative measures following monocular implantation (nondominant eye), with a large proportion of patients achieving Jaeger (J) 2 to J1 (~0.00 logMAR to ~0.10 logMAR) at the final follow-up. Although distance acuity is reduced slightly in the treated eye, binocular visual acuity and function remain very good (mean 0.10 logMAR or better). The safety of the inlay is well established and easily removable, and although some patients have developed corneal changes, these are clinically insignificant and the incidence appears to reduce markedly with advancements in KAMRA design, implantation technique, and femtosecond laser technology. This review aims to summarize the currently published peer-reviewed studies on the safety and efficacy of the KAMRA inlay and discusses the surgical and clinical outcomes with respect to the patient’s visual function. Keywords: presbyopia, refractive surgery, implants, cornea

Steven H Linn,1 David F Skanchy,2 Tyler S Quist,3 Jordan D Desautels,4 Majid Moshirfar1,5 1Department of Clinical Research, HDR Research Center, Hoopes Vision, Draper, UT, 2McGovern Medical School, The University of Texas Health Science Center at Houston, TX, 3University of Utah School of Medicine, Salt Lake City, UT, 4Tufts University School of Medicine, Boston, MA, 5John A Moran Eye Center, Department of Ophthalmology and Visual Sciences, University of Utah School of Medicine, Salt Lake City, UT, USA Purpose: The aim of this study was to compare stereoacuity before and after KAMRA corneal inlay implantation for the correction of presbyopia.Patients and methods: This is a prospective study of 60 patients who underwent KAMRA inlay implantation. Patients were examined before and 6 months after surgery for stereoacuity, uncorrected distance visual acuity (UDVA), and uncorrected near visual acuity (UNVA).Results: The mean stereoacuity before surgery was 29.5±28.1 arcsec (range: 20–200) and at 6 months was 29.8±26.4 arcsec (range: 20–200). The decline in stereoacuity was not statistically significant. At 6 months follow-up, UDVA was 20/25 or better in all 60 patients and UNVA was J2 (20/25) or better in 51 (85%) patients.Conclusion: There is no significant change in stereoacuity following KAMRA inlay implantation. The KAMRA inlay is a good treatment option for improving near vision in presbyopic patients while preserving stereoacuity and distance vision. Keywords: KAMRA, corneal inlay, AcuFocus, stereoacuity, presbyopia

The prevalence of presbyopia continues to increase every year. The therapeutic approaches to presbyopia cover the spectrum of non-surgical to surgical techniques. With recent advances in biocompatible materials, corneal inlays make a strong case for their place within the treatment spectrum. This article takes a closer look at three of the current corneal inlay models: KAMRA, Raindrop, and Presbia Flexivue Microlens. Each design approach and mode of action is described with data from key clinical trials. Furthermore, the ability to choose the most suitable corneal inlay is presented by comparing each model and identifying their similarities and differences. The article then concludes by touching on the future of corneal inlays, looking at associated conditions and complications and how to manage them, as well as an expert's personal point of view of enhanced ideas for continuing the growth and success of corneal inlays in the market. [ABSTRACT FROM AUTHOR]

Introduction: The visual outcome of cataract surgery in patients with a previous history of KAMRA inlay implantation is an emerging issue for which limited research exists. The purpose of this study is to describe postoperative visual outcomes in this patient population. Methods: This is a case series with retrospective chart review. Seven patients underwent cataract surgery following KAMRA corneal inlay implantation. Visual acuity was assessed before and after cataract surgery. Keratometry was measured before and after KAMRA inlay implantation, and optical biometry was performed prior to cataract surgery. Results: Postoperatively, uncorrected distance visual acuity (UDVA) was 20/20 in five (71%) patients and 20/40 or better in seven (100%) patients, corrected distance visual acuity (CDVA) was 20/20 or better in six (86%) patients and 20/25 in seven (100%) patients, and uncorrected near visual acuity (UNVA) was J1 in four (57%) patients, J2 or better in six (86%) patients, and J3 or better in seven (100%) patients. There was no significant change in keratometry after KAMRA inlay implantation. Biometry calculations accurately predicted intraocular lens (IOL) power after cataract surgery. Surgeons did not report a significant change in the surgical technique of cataract surgery. Conclusion: Patients who undergo cataract surgery with a previous history of KAMRA inlay implantation have good visual outcomes. Furthermore, intraocular lens (IOL) calculations accurately predict power, and there appears to be no significant change in surgical technique. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the effect of the femtosecond laser-assisted cataract surgery (FLACS) on porcine eyes implanted with a Kamra corneal inlay and to describe how the inlay may change the effect of the femtosecond laser on the lens.Methods: FLACS was performed on six porcine eyes and a Kamra corneal inlay had been implanted, exploring the lens under the surgical microscope. Another Kamra corneal inlay was attached to the upper part of the transparent hemisphere used for calibration of the femtosecond laser. Capsulorhexis, arcuate incisions, and phacofragmentation were carried out. The Kamra corneal inlay was compared with a nontreated one using a scanning electron microscope (SEM), and the hemisphere was analyzed with a surgical microscope.Results: Capsulorhexis and phacofragmentation were completed in all the porcine eyes, although accuracy to determine the exact effect on the lens was not possible to achieve. The effect of the femtosecond laser on the PMMA hemisphere through the Kamra corneal inlay showed the capsulorhexis was placed outside the outer margin of the inlay and a sharply sculpted fragmentation pattern with a three-dimensional (donut-shaped) annulus untreated beneath it. SEM images of the nontreated and the treated inlays were comparable. No ultrastructural changes were found in the treated Kamra corneal inlay.Conclusions: FLACS can be performed with a Kamra corneal inlay for surgical compensation of presbyopia without the risk of damaging the inlay. The Kamra corneal inlay acts as a screen that avoids the laser to reach the areas beneath its shadow, but not the exposed areas of the lens. [ABSTRACT FROM PUBLISHER]

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Presbyopia, the physiological change in near vision that develops with ageing, gradually affects individuals older than 40 years and is a growing cause of visual disability due to ageing demographics of the global population. The routine use of computers and 'smartphones', combined with the affluence of the 'baby boomers' generation has set high standards for near vision correction. Corneal inlays are a relatively new treatment modality that is effective at compensating for presbyopia. The dimensions of these devices vary from 2 to 3.8 mm in diameter and 5 to 32 μm in thickness. They are implanted in the anterior corneal stroma of the non-dominant eye, most commonly, in a femtosecond laser created corneal pocket. They improve near vision by increasing the depth of focus, creating a hyper-prolate region of increased central cornea power or providing a refractive add power. This article reviews the literature on the efficacy and safety of corneal inlays. [ABSTRACT FROM AUTHOR]

Intrastromal corneal inlays are an emerging treatment for presbyopic patients. The KAMRA™ small aperture inlay was the first such inlay to receive Conformité Européenne (CE) marking in 2005. It has been shown to improve uncorrected near and intermediate visual acuity without adversely affecting uncorrected distance visual acuity. Due to the age of presbyopic patients, they may eventually develop cataracts. In two such cases, we found that cataract surgery with the KAMRA implant left in place was not technically more difficult, and that the surgical procedure could be improved by additional ocular rotations to improve visualization. Biometry readings were reliable, and it appeared that the SRK/T formula was accurate for calculation of intraocular lens power. Cataract surgery with the KAMRA implant left in situ is a viable option for patients. [ABSTRACT FROM AUTHOR]

We report a series of three case reports of KAMRA inlay implantation procedures in presbyopic patients with a history of prior phakic intraocular lens implantation surgery. Three-month results showed a two to five-line improvement for uncorrected near visual acuity. The absolute uncorrected near visual acuity change for case 1 was from J4 to J2, for case 2 was from J6 to J4, and for case 3 was from J10 to J5. No significant change of uncorrected distance visual acuity was observed in all three cases. [ABSTRACT FROM AUTHOR]

Presbyopia is a growing problem in view of an aging global population and increasingly patients desire spectacle-free solutions to address this condition. Surgically implanted corneal inlays have been the topic of renewed research efforts in the past several years as a treatment option for presbyopia, with several approaches being used to modify the refractive properties of the cornea and enhance near vision. In this review we discuss historical approaches to corneal inlay surgery, critically appraise the current generation of presbyopia-correcting corneal inlays and their associated complications and consider the future prospects for emerging corneal inlay technologies that aim address the shortcomings of currently available inlays. • Presbyopia correction is a growing problem and the demand for spectacle-free outcomes is increasing. • Corneal inlay surgery offers the potential for minimally invasive and reversible correction of presbyopia. • Contemporary inlays have improved biocompatibility and outcomes but complications limit surgeon and patient acceptance. • Novel inlays with improved biocompatibility may overcome the limitations of current generation inlays. [ABSTRACT FROM AUTHOR]

The purpose of this study was to report visual prognosis after explantation of a small-aperture corneal inlay used for the treatment of presbyopia. This is a retrospective case series conducted at a single site in Draper, Utah, USA (Hoopes Vision). Medical records of 176 patients who had received a small-aperture corneal inlay (KAMRA™, AcuFocus Inc., Irvine, CA, USA) were reviewed. Patients who had undergone explantation of the device were identified. Uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA), and manifest refraction spherical equivalent (MRSE) were measured pre-implantation, post-implantation, pre-explantation, and post-explantation of the inlay. Ten eyes from ten patients were included in this study. The explantation rate was 5.7% over 31 months, with blurry vision as the most common complaint. After explantation, six patients achieved pre-implantation UDVA, and six achieved pre-implantation UNVA. Eight of nine patients who underwent final manifest refraction achieved pre-operative CDVA. All patients had residual donut-shaped corneal haze in the stroma at the previous position of the inlay. All patients experienced improvement in haze with 20% experiencing complete resolution. The degree of stromal haze was not related to the duration of implantation. Of the subset of patients who underwent explantation of their small-aperture corneal inlay, there was persistent loss of CDVA in 10%. The majority of patients experienced some level of residual stromal haze, which may contribute to deficits in UNVA and CDVA in few patients. A hyperopic shift induced by the corneal inlay may contribute to the blurry vision these patients experienced; there was a reduction of this shift post-explantation. While this device is removable, patients should expect some post-explantation changes such as residual haze with a small subset experiencing persistent deficits in CDVA., Competing Interests: Ethical issues have been completely observed by the authors. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. No conflict of interest has been presented. Phillip C Hoopes Jr, MD is a consultant for CorneaGen.

Purpose: To report the occurrence and the management of refractory interface haze that developed after epithelial ingrowth following small aperture inlay implantation., Observations: A 52 year-old man with sub-clinical anterior basement membrane dystrophy (ABMD) underwent combined hyperopic laser in situ keratomileusis and KAMRA corneal inlay implantation to correct presbyopia. Post-operatively, epithelial ingrowth developed requiring debridement and KAMRA removal. Significant diffuse interface haze, ground-glass in texture, involving the central 6 mm of the cornea developed the next day, and was refractory to topical and systemic steroids, necessitating flap irrigation, gentle scraping, and MMC application to the residual stromal bed after 12 days. The interface haze gradually improved to near complete resolution over 12-months., Conclusions and Importance: Epithelial ingrowth can lead to flap interface haze refractory to medical therapy. Early surgical intervention is key to haze resolution.

Purpose: The aim of this systematic review was to synthesize and appraise the evidence of the benefits of presbyopic correction on the cornea for visual function., Summary: Comprehensive search was conducted in MEDLINE using keywords like "presbylasik", "presbyopic refractive surgery", "corneal pseudoaccommodation" and "corneal multifocality". We reviewed corrected and uncorrected visual acuities for distance and near (uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA), distance corrected near visual acuity (DCNVA), corrected near visual acuity (CNVA)), along with the refractive outcomes in spherical equivalent (SE) and astigmatism comparing the differences observed between preoperative myopic and hyperopic patients, as well as among techniques. Thirty-one studies met the inclusion and quality criteria. Monovision provides excellent distance and near uncorrected acuities, but with a 17% retreatment and a 5% reversal rate. Initial multifocal ablations result in 12% loss of 2 or more lines of CDVA, and a 21% retreatment rate. Laser Blended Vision provides excellent UDVA, but with a 19% retreatment rate. Initial experiences with Supracor show moderate predictability and a 22% retreatment rate. Intracor results in 9% loss of 2 or more lines of CDVA. KAMRA provides excellent UDVA, with only a 1% retreatment rate, but a 6% reversal rate. Initial experiences with PresbyMAX provided excellent UNVA and DCNVA, showing excellent predictability and a 1% reversal rate., Conclusions: The findings have implications for clinicians and policymakers in the health-care industry and emphasize the need for additional trials examining this important and widely performed clinical procedure.