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Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study

Authors Gallardo MJ, Sarkisian SR Jr, Vold SD, Singh IP, Flowers BE, Campbell A, Dhamdhere K, Samuelson TW

Received 10 December 2020

Accepted for publication 20 January 2021

Published 10 February 2021 Volume 2021:15 Pages 481—489


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Dr Scott Fraser

Mark J Gallardo,1 Steven R Sarkisian Jr,2 Steven D Vold,3 Inder Paul Singh,4 Brian E Flowers,5 Anita Campbell,6 Kavita Dhamdhere,7 Thomas W Samuelson8 On behalf of the GEMINI study group

1El Paso Eye Surgeons, PA, El Paso, TX, USA; 2Oklahoma Eye Surgeons, PLLC, Oklahoma City, OK, USA; 3Vold Vision, Fayetteville, AR, USA; 4Eye Centers of Racine & Kenosha, Racine, WI, USA; 5Ophthalmology Associates, Fort Worth, TX, USA; 6Grene Vision Group, Wichita, KS, USA; 7Sight Sciences, Menlo Park, CA, USA; 8Minnesota Eye Consultants, Minneapolis, MN, USA

Correspondence: Kavita Dhamdhere Email

Purpose: To report interim 6-month safety and efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI® Surgical System concomitantly with phacoemulsification in patients with open-angle glaucoma (OAG).
Setting: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 states (Alabama, Arizona, Arkansas, Florida, Georgia, Iowa, Kansas, Montana, Nebraska, North Dakota, Oklahoma, Pennsylvania, Texas, and Wisconsin).
Design: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤ 33 mmHg on 1 to 4 hypotensive medications.
Methods: Medication washout prior to baseline diurnal IOP (Goldmann). Effectiveness outcomes included mean IOP and medications. Safety outcomes included adverse events (AE), best corrected visual acuity (BCVA) and secondary surgical interventions (SSI). Analysis includes descriptive statistics and t-tests evaluating change from baseline.
Results: A total of 137 patients were enrolled and treated. Mean diurnal IOP after washout was 23.8 ± 3.1 mmHg at baseline. At month 6, 78% (104/134) were medication free with IOP of 14.2 mmHg, a mean reduction of 9.0 mmHg (38%). 100% (104/104) had a ≥ 20% reduction in IOP and 86% (89/104) had IOP ≥ 6 and ≤ 18 mmHg. The mean number of medications at screening was 1.8 ± 0.9 and 0.6 ± 1.0 at month 6. AE included transient hyphema (4.6%) and IOP elevation ≥ 10 mmHg (2%). There were no AE for loss of BCVA or recurring hyphema. There were no SSI.
Conclusion: Canaloplasty followed with trabeculotomy and performed concomitantly with phacoemulsification has favorable intra and perioperative safety, significantly reduces IOP and anti-glaucoma medications through 6 months in eyes with mild-moderate OAG.

Keywords: viscodilation, MIGS, open-angle glaucoma, glaucoma surgery, canaloplasty, trabeculotomy, OMNI

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