9 results on '"Heersink, Sebastian"'
Search Results
2. Phase 3 Randomized Clinical Trial of the Safety and Efficacy of Travoprost Intraocular Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension
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Ang, Robert E., Heersink, Sebastian B., Vold, Steven, Atodaria, Neil, Brubaker, Jacob, Goldberg, Damien, Lin, Christopher, Nguyen, Betsy, Schultz, Mitchell, Silverstein, Bruce, Sorenson, Robert, Bashford, Kent, Burden, James H., ElMallah, Mohammed, Kim, Joshua, Lambright, Benjamin, McCabe, Cathleen, Shetty, Rajesh, Smith, Steven, Tyson, Farrell, Jones, Jason, D’Ambrosio, Francis, Wu, Bin, Basha, Mahdi, Chu, Ralph, Gira, Joseph, Swan, Russell, Baartman, Brandon, Wellish, Kent, Sarkisian, Steven R., Jr., Lee, Andy M., Berdahl, John P., Doan, Long V., Stephens, Kerry G., Kothe, Angela C., Usner, Dale W., Katz, L. Jay, and Navratil, Tomas
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- 2024
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3. Combining laser with MIGS to impact intraocular pressure: Surgeons can perform several procedures with cataract surgery
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Heersink, Sebastian B.
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Glaucoma -- Development and progression ,Ophthalmology ,Cataract -- Surgery -- Development and progression ,Health - Abstract
Special to Ophthalmology Times[R] Elevated intraocular pressure (IOP) is the most significant risk factor for developing glaucoma and the only known risk factor that is currently treatable. In patients who [...]
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- 2021
4. Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2)
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Bacharach, Jason, Tatham, Andrew, Ferguson, Gloria, Belalcázar, Sandra, Thieme, Hagen, Goodkin, Margot L., Chen, Michelle Y., Guo, Qiang, Liu, Jeen, Robinson, Michael R., Bejanian, Marina, Wirta, David L., Alezzandrini, Arturo, Bercovich, Gabriel, Deromedis, Pablo, Furno Sola, Federico, Gentile, Carolina, Lerner, Simon, Lupinacci, Anahi, Zeolite, Carlos, Birt, Catherine, Crichton, Andrew, Gagne, Sebastien, Giunta, Michael, Harasymowycz, Paul, Jinapriya, Delan, Nicolela, Marcelo, Nixon, Donald, Saurel, Patrick, Yan, David, Yuen, Darana, Arango, Santiago, Martinez, Alexander, Parra Restrepo, Juan C., Korda, Vladimir, Kadlecova, Jana, Svacinova, Jitka, Khairy, Hany, El Ibiary, Hani, El Sanabary, Zeinab, Bell, Katharina, Greslechner, Roman, Koch, Jöerg, Lorenz, Katrin, Oberacher-Velten, Isabel, Schmickler, Stefanie, Schuart, Claudie, Bandello, Francesco, Cagini, Carlos, Figus, Michele, Mastropasqua, Leonardo, Rossetti, Luca, Uva, Maurizio G., Thayanithi, Sandragasu, Wells, Anthony, Husain, Rahat, Koh, Victor, Lim, Dawn, Tin, Aung, Gous, Petrus, Venter, Lynette, Kee, Changwon, Kook, Michael, Park, Ki-Ho, Eraslan, Muhsin, Kayikcioglu, Ozcan, Yildirim, Nilgun, Bourne, Rupert R. A., Choudhary, Anshoo, Cordeiro, Francesca, Dubois, Vincent, Kirwan, James, Lim, Sheng, Martin, Keith, Nithy, Antony, Prabhu, Avinash, Amir, Ahmad, Barnebey, Howard, Beck, Allen, Bergstrom, Lance, Borisuth, Navaneet, Branch, James D., Briggs, Jonathan, Bylsma, Stephen, Chang, Peter, Christie, William, Cotter, Frank, Depenbusch, Michael, Goldberg, Damien F., Greiner, Jack, Gupta, Shailesh, Gutmark, Ron, Han, Ying, Heersink, Sebastian, Kahook, Malik, Khouri, Albert, Kim, Joshua, Kushnick, Howard, Lin, Christopher, Luchs, Jodi, Maharaj, Arindel, Mansberger, Steven L., Mares, Frank, Miller-Ellis, Eydie, Modi, Satish, Paul, Matthew, Pitha, Ian, Saltzmann, Robert, Sato, Michelle, Savestsky, Michael, Segal, Bruce, Segal, Zachary, Serle, Janet, Sherwood, Mark, Singh, Inder, Smith, Stephen E., Song, Julia, Sorenson, Robert, Tenkman, Lawrence, Tekwani, Navin, Tubbs, Carl, Tyson, Farrell, Vizzeri, Gianmarco, Vold, Steven, Vu, Qui, Warren, Kimberly S., and Wirta, David
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genetic structures ,sense organs ,eye diseases - Abstract
Objective-\ud \ud To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).\ud \ud Methods-\ud \ud This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD).\ud \ud Results-\ud \ud Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2–7.4, 6.5–7.8, and 6.1–6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group.\ud \ud Conclusions-\ud \ud The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma.
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- 2021
5. First Real-World, Multicenter, Post-Marketing, Retrospective Study of Dexamethasone Intraocular Suspension for Inflammation After Cataract Surgery.
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Bacharach, Jason, McCabe, Cathleen, Jackson, Mitchell, Rao, Sanjay, Singh, I Paul, Heersink, Sebastian, Radcliffe, Nathan, Weinstock, Robert, Paggiarino, Dario, and Patel, Keyur
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CATARACT surgery ,EYE inflammation ,OPHTHALMIC surgery ,CLINICAL trials ,PHACOEMULSIFICATION ,DEXAMETHASONE - Abstract
Purpose: To evaluate dexamethasone intraocular suspension 9% (intraocular DXM) in real-world clinical use to manage inflammation associated with cataract surgery. Setting: Patients who underwent cataract surgery and received intraocular DXM at 22 outpatient eye surgery centers in the US. Design: Retrospective, observational chart review. Methods: Records of all patients who received intraocular DXM from March to December 2019 at participating centers were reviewed. Main Outcome Measures: Outcomes included anterior chamber cell (ACC) grades, anterior chamber flare (ACF) grades, and visual acuity, as well as intraocular pressure (IOP) and adverse events (AEs) at postoperative days (PODs) 1, 8, 14, 30. Descriptive statistics were generated. Results: The study population included 527 patients (641 eyes), with glaucoma history in 66 patients (80 eyes). Among eyes with recorded ACC grades, the percentage with grade 0 increased from 40% at POD 1 to 89.7% at POD 30, with similar results in eyes with glaucoma history. Among eyes with recorded ACF grades, the percentage with grade 0 increased from 78.4% at POD 1 to 97.1% at POD 30. At POD 30, 96.6% eyes with recorded results achieved target acuity. Mean IOP was 18.6 mmHg at POD 1 but declined to ≤ 15.2 mmHg thereafter. Investigators reported 22 AEs in 20 patients, all reported mild or moderate, the most common: IOP increase (7 events). Conclusion: Patients undergoing cataract surgery and treated with intraocular DXM showed favorable inflammatory and visual outcomes, without unanticipated safety problems, consistent with results of previous controlled clinical trials. [ABSTRACT FROM AUTHOR]
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- 2022
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6. Combining laser-based treatment with MIGS to reduce IOP levels: Prompt, careful use of laser minimises postoperative adverse effects.
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Heersink, Sebastian B.
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LASER photocoagulation , *CONTINUOUS wave lasers , *LASERS - Published
- 2022
7. Phase 3 Randomized Clinical Trial of the Safety and Efficacy of Travoprost Intraocular Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension.
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Sarkisian, Steven R., Ang, Robert E., Lee, Andy M., Berdahl, John P., Heersink, Sebastian B., Burden, James H., Doan, Long V., Stephens, Kerry G., Kothe, Angela C., Usner, Dale W., Katz, L. Jay, and Navratil, Tomas
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CLINICAL trials , *OPEN-angle glaucoma , *DRUG delivery systems , *INTRAOCULAR pressure , *OCULAR hypertension - Abstract
To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of 2 models of the travoprost intraocular implant (fast-eluting [FE] and slow-eluting [SE] types) from 1 of 2 phase 3 trials (the GC-010 trial). Multicenter, randomized, double-masked, sham-controlled, noninferiority trial. Patients with open-angle glaucoma or ocular hypertension having an unmedicated baseline mean diurnal IOP (average of 8 am , 10 am , and 4 pm time points) of ≥ 21 mmHg, and IOP of ≤ 36 mmHg at each of the 8 am , 10 am , and 4 pm timepoints at baseline. Study eyes were randomized to the travoprost intraocular implant (FE implant [n = 200] or SE implant [n = 197] model) or to timolol ophthalmic solution 0.5% twice daily (n = 193). The primary outcome was mean change from baseline IOP in the study eye at 8 am and 10 am , at each of day 10, week 6, and month 3. Safety outcomes included adverse events (AEs) and ophthalmic assessments. Mean IOP reduction from baseline over the 6 time points ranged from 6.6 to 8.4 mmHg for the FE implant group, from 6.6 to 8.5 mmHg for the SE implant group, and from 6.5 to 7.7 mmHg for the timolol group. The primary efficacy end point was met; the upper limit of the 95% confidence interval of the difference between the implant groups and the timolol group was < 1 mmHg at all 6 time points. Study eye AEs, most of mild or moderate severity, were reported in 21.5%, 27.2%, and 10.8% of patients in the FE implant, SE implant, and timolol groups, respectively. The most common AEs included iritis (FE implant, 0.5%; SE implant, 5.1%), ocular hyperemia (FE implant, 3.0%; SE implant, 2.6%), reduced visual acuity (FE implant, 1.0%; SE implant, 4.1%; timolol, 0.5%), and IOP increased (FE implant, 3.5%; SE implant, 2.6%; timolol, 2.1%). One serious study eye AE occurred (endophthalmitis). The travoprost intraocular implant demonstrated robust IOP reduction over the 3-month primary efficacy evaluation period after a single administration. The IOP-lowering efficacy in both implant groups was statistically and clinically noninferior to that in the timolol group, with a favorable safety profile. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. [ABSTRACT FROM AUTHOR]
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- 2024
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8. Actinic Granuloma of the Conjunctiva: Case Series and Review of the Literature.
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Magan T, Rapuano CJ, Ayres BD, Skeens HM, Goyal V, Heersink S, Meghpara BB, Syed ZA, Eagle RC Jr, and Milman T
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- Adult, Conjunctiva, Female, Granuloma diagnosis, Humans, Male, Retrospective Studies, Neoplasm Recurrence, Local, Pterygium diagnosis, Pterygium surgery
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Purpose: To characterize the clinical and histopathologic features of actinic granuloma of the conjunctiva., Design: Retrospective observational case series METHODS: Institutional pathology records between 2014 and 2020 were searched for all cases of conjunctival actinic granuloma. Information collected included age, sex, ocular and medical history, clinical findings, laboratory workup, treatment, follow-up, pathologic diagnosis, and histopathologic inflammation pattern., Results: Eight eyes of 8 patients, 5 men and 3 women, with a median age of 43 years (mean 49, range 24-83) were identified. Clinical diagnosis was pterygium (n = 4, 50%), inflamed pterygium (n = 1, 13%), pterygium vs conjunctival squamous cell carcinoma (n = 1, 13%), episcleritis vs inflamed pinguecula (n = 1, 13%), and scleritis vs keratoacanthoma (n = 1, 13%). Of 5 lesions with follow-up information, none recurred following excision with a median follow-up of 9 weeks (mean 19 weeks, range 1-61 weeks). Allergy/atopy was documented in 4 of 7 (57%) patients with available medical information. There were no other systemic associations. Histopathologically, actinic granuloma was associated with pterygium (n = 6, 75%) and pinguecula (n = 2, 25%). All lesions were composed predominantly of histiocytes and a variable number of foreign body-type giant cells associated with a focus of severe actinic elastosis. The inflammatory pattern was giant cell (n = 4, 50%), sarcoidal (n = 2, 25%), histiocytic (n = 1, 13%), and combined histiocytic and sarcoidal (n = 1, 13%)., Conclusion: Conjunctival actinic granuloma has diverse clinical and histopathologic manifestations, which need to be distinguished from other autoimmune, neoplastic, and infectious etiologies. This lesion frequently occurs in pre-existing pterygium and pinguecula and may be associated with allergy and atopy., (Copyright © 2021 Elsevier Inc. All rights reserved.)
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- 2021
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9. Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study.
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Hirsch L, Cotliar J, Vold S, Selvadurai D, Campbell A, Ferreira G, Aminlari A, Cho A, Heersink S, Hochman M, Gallardo M, Williamson B, Phan R, Nelson C, and Dickerson JE Jr
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- Humans, Intraocular Pressure, Retrospective Studies, Treatment Outcome, Cataract complications, Glaucoma, Open-Angle surgery, Ophthalmology, Trabeculectomy
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Purpose: To provide safety and effectiveness outcomes 12 months postsurgically for sequential canaloplasty and trabeculotomy with the OMNI system combined with cataract surgery in mild-to-moderate open-angle glaucoma (OAG)., Setting: Eleven ophthalmology practices and surgery centers located in 8 U.S. states., Design: Retrospective, multicenter, single arm., Methods: Twelve surgeons contributed 81 patients meeting eligibility criteria: OAG, 12-month follow-up, and medicated intraocular pressure (IOP) 36 mm Hg or less on 4 or less medications preoperatively. Analysis was stratified by baseline IOP: more than 18 mm Hg (Group 1) and 18 mm Hg (Group 2) or less. Success was defined as proportion with 20% reduction or greater in IOP or IOP between 6 and 18 mm Hg (inclusive) and on the same or fewer medications without secondary surgical intervention (SSI). Other endpoints included mean IOP and medications at 12 months. Safety included corrected distance visual acuity and adverse events (AEs)., Results: Of the 81 patients included, primary success was met by 79% in Group 1 and 81% in Group 2. The mean IOP was reduced in Group 1 (21.9 to 15.1 mm Hg, P < .0001) and remained controlled in Group 2 (14.1 to 13.4 mm Hg, P = .3177). Medications went from 2.0 ± 1.3 to 1.1 ± 1.1 in Group 1 and from 1.6 ± 1.3 to 0.9 ± 1.2 in Group 2. AEs were typical for cataract or angle surgery: mild inflammation (11%), IOP spikes (5%), and hyphema (4%). Four patients (5%) required an SSI., Conclusions: The OMNI system provided effective IOP reduction, sustained IOP control, and meaningful medication reduction for up to 12 months postoperative., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of ASCRS and ESCRS.)
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- 2021
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