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

Overview
Journal Clin Ophthalmol
Publisher Dove Medical Press
Specialty Ophthalmology
Date 2021 Feb 19
PMID 33603325
Citations 13
Authors
Affiliations
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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.

Citing Articles

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

Greenwood M, Yadgarov A, Flowers B, Sarkisian Jr S, Ohene-Nyako A, Dickerson Jr J Clin Ophthalmol. 2023; 17:3817-3824.

PMID: 38105915 PMC: 10725746. DOI: 10.2147/OPTH.S446486.


First-Generation iStent Bypass Implantation versus ab Externo Canaloplasty Combined with Phacoemulsification in Patients with Primary Open Angle Glaucoma-12-Month Follow-Up.

Golaszewska K, Obuchowska I, Konopinska J J Clin Med. 2023; 12(17).

PMID: 37685778 PMC: 10488869. DOI: 10.3390/jcm12175711.


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