Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Dec 12:17:3817-3824.
doi: 10.2147/OPTH.S446486. eCollection 2023.

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  1 , Arkadiy Yadgarov  2 , Brian E Flowers  3 , Steven R Sarkisian Jr  4 , Afua Ohene-Nyako  5 , Jaime E Dickerson Jr  5   6 ; GEMINI 2 STUDY GROUP
Affiliations

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 et al. Clin Ophthalmol. .

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.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Mean IOP (SD) at each visit. Medication washout prior to each visit. All visits P<0.00001 versus Baseline.
Figure 2
Figure 2
Mean medication (SD) use at each visit (prior to medication washout). All visits P<0.00001 versus Baseline.
See this image and copyright information in PMC

References

    1. Yang SA, Mitchell W, Hall N., et al. Trends and usage patterns of minimally invasive glaucoma surgery in the United States: IRIS® registry analysis 2013–2018. Ophthalmol Glaucoma. 2021;4(6):558–568. doi: 10.1016/j.ogla.2021.03.012 - DOI - PubMed
    1. Bicket AK, Le JT, Azuara-Blanco A, et al. Minimally invasive glaucoma surgical techniques for open-angle glaucoma: an overview of cochrane systematic reviews and network meta-analysis. JAMA Ophthalmol. 2021;139(9):983–989. doi: 10.1001/jamaophthalmol.2021.2351 - DOI - PMC - PubMed
    1. Birnbaum FA, Neeson C, Solá-Del Valle D. Microinvasive glaucoma surgery: an evidence-based review. Semin Ophthalmol. 2021;36(8):772–786. doi: 10.1080/08820538.2021.1903513 - DOI - PubMed
    1. Gallardo MJ, Pyfer MF, Vold SD, et al. Canaloplasty and trabeculotomy combined with phacoemulsification for glaucoma: 12-month results of the GEMINI study. Clin Ophthalmol. 2022;16:1225–1234. doi: 10.2147/OPTH.S362932 - DOI - PMC - PubMed
    1. Samuelson TW, Sarkisian SR, Lubeck DM, et al. Prospective, randomized, controlled pivotal trial of an ab interno implanted trabecular micro-bypass in primary open-angle glaucoma and cataract: two-year results. Ophthalmology. 2019;126(6):811–821. doi: 10.1016/j.ophtha.2019.03.006 - DOI - PubMed