Herbert Reitsamer1, Chelvin Sng2,3,4, Vanessa Vera5, Markus Lenzhofer1, Keith Barton6,7, Ingeborg Stalmans8. 1. Department of Ophthalmology and Optometry, University Clinic Salzburg, SALK/Paracelsus Medical University, Salzburg, Austria. 2. Moorfields Eye Hospital, London, UK. chelvin@gmail.com. 3. Department of Ophthalmology, National University Hospital, 1E Kent Ridge Road, NUHS Tower Block, Level 7, Singapore, 119228, Singapore. chelvin@gmail.com. 4. Singapore Eye Research Institute, Singapore, Singapore. chelvin@gmail.com. 5. Department of Ophthalmology, Unidad Oftalmologica de Caracas, Caracas, Venezuela. 6. Moorfields Eye Hospital, London, UK. 7. Department of Ophthalmology, National University Hospital, 1E Kent Ridge Road, NUHS Tower Block, Level 7, Singapore, 119228, Singapore. 8. Department of Ophthalmology, University Hospitals UZ Leuven, Leuven, Belgium.
Abstract
PURPOSE: To evaluate the effectiveness of an ab interno subconjunctival gelatin implant as primary surgical intervention in reducing intraocular pressure (IOP) and IOP-lowering medication count in medically uncontrolled moderate primary open-angle glaucoma (POAG). METHODS: In this prospective, non-randomized, open-label, multicenter, 2-year study, eyes with medicated baseline IOP 18-33 mmHg on 1-4 topical medications were implanted with (phaco + implant) or without (implant alone) phacoemulsification. Changes in mean IOP and medication count at months 12 (primary outcomes) and 24, clinical success rate (eyes [%] achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention), intraoperative complications, and postoperative adverse events were assessed. RESULTS: The modified intent-to-treat population included 202 eyes (of 218 implanted). Changes (standard deviation) in mean IOP and medication count from baseline were - 6.5 (5.3) mmHg and - 1.7 (1.3) at month 12 and - 6.2 (4.9) mmHg and - 1.5 (1.4) at month 24, respectively (all P < 0.001). Mean medicated baseline IOP was reduced from 21.4 (3.6) to 14.9 (4.5) mmHg at 12 months and 15.2 (4.2) mmHg at 24 months, with similar results in both treatment groups. The clinical success rate was 67.6% at 12 months and 65.8% at 24 months. Overall, 51.1 (12 months) and 44.7% (24 months) of eyes were medication-free. The implant safety profile compared favorably with that published for trabeculectomy and tube shunts. CONCLUSIONS: The gelatin implant effectively reduced IOP and medication needs over 2 years in POAG uncontrolled medically, with an acceptable safety profile. ClinicalTrials.gov registration number: NCT02006693 (registered in the USA).
PURPOSE: To evaluate the effectiveness of an ab interno subconjunctival gelatin implant as primary surgical intervention in reducing intraocular pressure (IOP) and IOP-lowering medication count in medically uncontrolled moderate primary open-angle glaucoma (POAG). METHODS: In this prospective, non-randomized, open-label, multicenter, 2-year study, eyes with medicated baseline IOP 18-33 mmHg on 1-4 topical medications were implanted with (phaco + implant) or without (implant alone) phacoemulsification. Changes in mean IOP and medication count at months 12 (primary outcomes) and 24, clinical success rate (eyes [%] achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention), intraoperative complications, and postoperative adverse events were assessed. RESULTS: The modified intent-to-treat population included 202 eyes (of 218 implanted). Changes (standard deviation) in mean IOP and medication count from baseline were - 6.5 (5.3) mmHg and - 1.7 (1.3) at month 12 and - 6.2 (4.9) mmHg and - 1.5 (1.4) at month 24, respectively (all P < 0.001). Mean medicated baseline IOP was reduced from 21.4 (3.6) to 14.9 (4.5) mmHg at 12 months and 15.2 (4.2) mmHg at 24 months, with similar results in both treatment groups. The clinical success rate was 67.6% at 12 months and 65.8% at 24 months. Overall, 51.1 (12 months) and 44.7% (24 months) of eyes were medication-free. The implant safety profile compared favorably with that published for trabeculectomy and tube shunts. CONCLUSIONS: The gelatin implant effectively reduced IOP and medication needs over 2 years in POAG uncontrolled medically, with an acceptable safety profile. ClinicalTrials.gov registration number: NCT02006693 (registered in the USA).
Authors: V T Pérez-Torregrosa; Á Olate-Pérez; M Cerdà-Ibáñez; A Gargallo-Benedicto; V Osorio-Alayo; A Barreiro-Rego; A Duch-Samper Journal: Arch Soc Esp Oftalmol Date: 2016-03-16
Authors: Brian J Song; Meera Ramanathan; Esteban Morales; Simon K Law; JoAnn A Giaconi; Anne L Coleman; Joseph Caprioli Journal: J Glaucoma Date: 2016-09 Impact factor: 2.503
Authors: Herbert Reitsamer; Vanessa Vera; Simon Ruben; Leon Au; Jorge Vila-Arteaga; Miguel Teus; Markus Lenzhofer; Andrew Shirlaw; Zhanying Bai; Mini Balaram; Ingeborg Stalmans Journal: Acta Ophthalmol Date: 2021-05-10 Impact factor: 3.988