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

Michael D Greenwood; Arkadiy Yadgarov; Brian E Flowers; Steven R Sarkisian Jr; Afua Ohene-Nyako; Jaime E Dickerson Jr; GEMINI 2 STUDY GROUP

doi:10.2147/OPTH.S446486

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

Clin Ophthalmol. 2023 Dec 12:17:3817-3824. doi: 10.2147/OPTH.S446486. eCollection 2023.

Authors

Michael D Greenwood¹, Arkadiy Yadgarov², Brian E Flowers³, Steven R Sarkisian Jr⁴, Afua Ohene-Nyako⁵, Jaime E Dickerson Jr^{5

6}; GEMINI 2 STUDY GROUP

Affiliations

¹ Vance Thompson Vision, West Fargo, ND, USA.
² Omni Eye Services, Atlanta, GA, USA.
³ Ophthalmology Associates, Fort Worth, TX, USA.
⁴ Oklahoma Eye Surgeons, Oklahoma City, OK, USA.
⁵ Sight Sciences, Menlo Park, CA, USA.
⁶ North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TX, USA.

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: MIGS; OMNI; canaloplasty; glaucoma; trabeculotomy.

Grants and funding

Sight Sciences Inc. provided financial support.