Abstract
Purpose :
To provide prospective, long-term clinical safety and effectiveness results for subjects treated with ab-interno canaloplasty and trabeculotomy (CT, OMNI Surgical System) either as a standalone procedure (SA) or in combination with cataract surgery (+CAT).
Methods :
Subjects that had undergone CT as part of the 12-month GEMINI (NCT03861169) and ORION (NCT04465630) clinical studies were enrolled in observational long-term follow-up studies, GEMINI 2 (NCT05044793), and ORION 2 (NCT04872348). These were prospective, multi-center, IRB-approved studies with follow-up through 24 (ORION 2) and 36 (GEMINI 2) months. Subjects had undergone SA CT (ORION) or +CAT CT (GEMINI), had mild to moderate POAG, a diurnal intraocular pressure (DIOP, measured at 9AM, Noon, 4PM) post washout of ≥22.5 mmHg and 21-36 mmHg, respectively, and were on 1-5 (ORION) or 0-4 (GEMINI) topical IOP-lowering medications pre-washout. Outcome measures included reduction in mean unmedicated DIOP, reduction in mean number of IOP-lowering medications, and percent of eyes with ≥20% reduction in unmedicated DIOP at the extended follow-up endpoint (months 24 and 36, respectively).
Results :
24-month SA subjects (n=17) had mean (SD) baseline, unmedicated DIOP of 26.1 (4.0) mmHg and 16.0 (3.4) mmHg at 24 months with mean medication use going from 2.1 (1.0) to 0.7 (1.1). 36-month +CAT subjects (n=66) were 23.1 (2.7) mmHg at baseline and 16.3 (3.3) mmHg at 36 months with medication use going from 1.6 (0.9) to 0.3 (0.6). 84.6% of subjects in ORION and 78% in GEMINI had a ≥20% reduction in DIOP from baseline at 24 and 36 months, respectively. Additionally, 67% and 74% of subjects were medication free in ORION and GEMINI at 24 and 36 months. One subject in the +CAT cohort and one in the SA cohort required a secondary surgical intervention over the follow-up period.
Conclusions :
Long-term follow-up for subjects in the ORION and GEMINI studies showed sustained long-term effectiveness of CT with the OMNI device whether combined with cataract surgery or as a standalone procedure for IOP and medication reduction in mild to moderate glaucoma.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.