Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

• Published in: Graefe's archive for clinical and experimental ophthalmology 2019-05, Vol.257 (5), p.983-996
• Main Authors: Reitsamer, Herbert, Sng, Chelvin, Vera, Vanessa, Lenzhofer, Markus, Barton, Keith, Stalmans, Ingeborg
• Format: Article
• Language: English
• Subjects: Eye; Gelatin; Glaucoma; Medicine; Medicine & Public Health; Ophthalmology; Shunts
• ISSN: 0721-832X; 1435-702X
• DOI: 10.1007/s00417-019-04251-z

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