36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma

Abstract

Purpose

To provide long-term intraocular pressure (IOP) and ocular hypotensive medication usage outcomes through 36 months for patients treated with canaloplasty and trabeculotomy (OMNI Surgical System) combined with cataract surgery as participants in the GEMINI study.

Setting

Eleven ophthalmology practices in 10 US states.

Design

Non-interventional 36-month extension of the 12-month, prospective, multicenter, GEMINI study.

Methods

GEMINI patients had visually significant cataract, mild-to-moderate glaucoma (ICD-10 guidelines), medicated IOP <33 mmHg, and unmedicated mean diurnal IOP (DIOP) (after washout) 21–36 mmHg. Patients from GEMINI were eligible for inclusion. Outcome measures were reduction in mean unmedicated DIOP, reduction in mean IOP-lowering medications, percent of eyes with ≥20% reduction in unmedicated DIOP, and percent of eyes with unmedicated DIOP ≥6 and ≤18 mmHg.

Results

A total of 66 patients provided consent and were enrolled. Mean (SD) unmedicated DIOP was 23.1 (2.7) mmHg at baseline, 16.7 (4.1), 16.3 (3.3) at 24 and 36 months; mean reductions of 6.2 (4.1) and 6.9 (3.4) mmHg. Twelve-month IOP at the end of GEMINI was 15.6 mmHg. The proportion of eyes with ≥20% reduction in IOP was 77% and 78% (months 24 and 36) compared to 87% at month 12 from GEMINI. About 68% of patients had an IOP between 6 and 18 mmHg at 24 months and 71% at 36 months. Mean IOP-lowering medications was 1.7 at baseline, which was reduced to 0.4 (24 months, −1.3) and 0.3 (36 months, −1.4). About 74% of patients (46 of 62) were medication free at 36 months.

Conclusion

GEMINI demonstrated 12-month effectiveness of canaloplasty and trabeculotomy with OMNI combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma. However, longer-term data is key to the decision making in the selection of a surgical treatment. This GEMINI extension demonstrates that the 12-month outcomes from GEMINI were sustained through 36 months.

Keywords:

• canaloplasty
• trabeculotomy
• MIGS
• OMNI
• glaucoma

Data Sharing Statement

The authors do not intend to share participant level data. Other queries or requests should be directed to the corresponding author (JD).

Acknowledgments

GEMINI 2 STUDY GROUP: Brandon Baartman, Anita Campbell, Brian Flowers, Mark Gallardo, Michael Greenwood, Sebastian Heersink, Mark Pyfer, Steven Sarkisian, Inder Paul Singh, Russell Swan, Arkadiy Yadgarov.

Disclosure

MDG has received research support from Sight Sciences. AY is a consultant to Sight Sciences and has received research support from Sight Sciences. SRS is a consultant and speaker for Sight Sciences and has an equity interest in Sight Sciences. BEF has consulted for and received research support from Sight Sciences. He also reports grants, personal fees from Alcon, IStar, Glaukos, Sight science, New world medical, Sanoculis, and Iantrek, outside the submitted work. JED and AON are employees of Sight Sciences.

Additional information

Funding

Sight Sciences Inc. provided financial support.