Dataset Information

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

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.

SUBMITTER: Gallardo MJ

PROVIDER: S-EPMC7882439 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

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

Gallardo Mark J MJ Sarkisian Steven R SR Vold Steven D SD Singh Inder Paul IP Flowers Brian E BE Campbell Anita A Dhamdhere Kavita K Samuelson Thomas W TW

Clinical ophthalmology (Auckland, N.Z.) 20210210

<h4>Purpose</h4>To report interim 6-month safety and efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI<sup>®</sup> Surgical System concomitantly with phacoemulsification in patients with open-angle glaucoma (OAG).<h4>Setting</h4>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).<h4>Design</ ...[more]

PMID: 33603325

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Project description:PurposeThe study aimed to compare the 12-month post-operative outcomes of iStent and iStent inject W (inject W), and the factors associated with their success in open-angle glaucoma.MethodsThis single-center, retrospective comparative case series evaluated the medical records of patients who underwent iStent (comprising 1 stent) or inject W (comprising 2 stents) implantation with cataract surgery for primary open-angle glaucoma and normal tension glaucoma between January 2019 and March 2022. The 12-month post-operative efficacy outcomes included intraocular pressure (IOP), glaucoma medications, and survival analysis of the probability of success. "Failure" was defined as any of the following conditions compared to baseline: 1) IOP elevation, 2) increased glaucoma medication, or 3) IOP decline not exceeding 20% when glaucoma medication scores were comparable, and 4) need for additional glaucoma surgery. The safety outcomes included intra- and post-operative adverse events and changes in the best-corrected visual acuity and visual field.ResultsThe study comprised 55 eyes in the iStent and 105 in the inject W groups. At 12 months, treatment success was achieved in 66.0% of iStent and 78.4% of inject W eyes. The mean IOP was lower, and the percent reduction from baseline was equal in iStent-treated eyes (8.0% reduction, 14.8 mmHg to 13.7 mmHg, P<0.01) and inject W-treated eyes (11.9% reduction, 15.0 mmHg to 13.8 mmHg, P<0.01) (between-group comparison, P = 0.23). The mean medication burden decreased significantly from 2.5 to 1.1 for iStent (55.0% reduction, P<0.01) and 2.9 to 1.7 for iStent inject (46.8% reduction, P<0.01), with no significant differences between the two groups (P = 0.17). Both devices exhibited excellent safety.ConclusionsBoth devices significantly reduced IOP and glaucoma medication 12 months post-operatively. The outcome measures did not differ significantly between the two groups, and lower baseline IOP was predictive of surgical failure.

Dataset Information

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

Purpose

Setting

Design

Methods

Results

Conclusion

Publications

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

Similar Datasets

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