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. 2021 Feb 10:15:481-489.
doi: 10.2147/OPTH.S296740. eCollection 2021.

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

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 Samuelson  8 ; GEMINI study group
Affiliations

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

Mark J Gallardo et al. Clin Ophthalmol. .

Abstract

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: MIGS; OMNI; canaloplasty; glaucoma surgery; open-angle glaucoma; trabeculotomy; viscodilation.

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Conflict of interest statement

SRS Jr and SDV are consultants and speakers for Sight Sciences. SRS Jr reports grants, Allergan, Glaukos, BVI, Santen, Bausch and Lomb, Aerie, Alcon, Ocular Science, and Katena, outside the submitted work. SDV reports grants from Glaukos, Ivantis, Allergan, and iStar Medical, outside the submitted work. BEF reports personal fees from Sight Science, during the conduct of the study; grants, personal fees from Alcon, iStar Medical, Ivantis, Glaukos; grants from Aerie Pharmaceuticals, Nicox, and Santen; personal fees from Bausch and Lomb and New World Medical, outside the submitted work. TWS reports personal fees from Sight Science, Glaukos, Ivantis, New World Medical, Santen, Allergan, Alcon Surgical, and MicroOptix, during the conduct of the study; personal fees from Sight Science, outside the submitted work. All other authors are speakers for Sight Sciences. KD is an employee of Sight Sciences, Inc. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Mean IOP at each time point for the full cohort (n=137). Error bars represent standard deviation. *Indicates P<0.0001.
Figure 2
Figure 2
Mean IOP at each time point among patients on no medications at each time point. Error bars represent standard deviation. *Indicates P<0.0001.
Figure 3
Figure 3
Ocular hypotensive medication use. Error bars represent standard deviation. *Indicates P<0.0001.
See this image and copyright information in PMC

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