Loading clinical trials...

Study of OMNI System in OAG (GEMINI) | Clinical Trials | Clareo Health

COMPLETEDNA

Study of OMNI System in OAG (GEMINI)

Prospective, Multi-Center, Single-Arm Post-Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma

NCT03861169•Sight Sciences, Inc.

View on ClinicalTrials.gov

Summary

This study will prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed using the OMNI Surgical System in combination with Cataract Extraction on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with mild-moderate open angle glaucoma (OAG).

Detailed Description

This prospective, multicenter, single-arm, post-market clinical study will evaluate the impact of ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System in conjunction with cataract surgery on IOP and the use of hypotensive medications in patients with mild to moderate open angle glaucoma.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Only one eye of each subject was eligible (the "study eye"), and all ocular criteria listed below applied to the study eye.
•1. Male or female subjects, 22 years or older
•2. Visually significant cataract
•3. Diagnosed with mild to moderate open-angle glaucoma (e.g., primary open-angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical record per ICD-10 guidelines
•4. At screening, a medicated IOP ≤ 33 mmHg and on 1-4 IOP-lowering medications1 with a stable medication regimen for two months prior to screening visit
•5. At baseline, unmedicated diurnal IOP 21-36 mmHg and IOP at least 3 mmHg higher than screening IOP
•6. Scheduled for cataract extraction followed by ab- interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System
•7. Shaffer grade of ≥ 3 in all four quadrants
•8. Potential of good best corrected visual acuity post cataract extraction, in the Investigator's judgment
•9. Able and willing to comply with the protocol, including all follow-up visits.
+1 more criteria

Exclusion Criteria

•All criteria listed below applied to the study eye; both eyes of a single subject need not have been eligible for the study.
•1. Any of the following prior treatments for glaucoma:
•* Laser trabeculoplasty ≤ 3 months prior to baseline
•* Implanted with iStent, CyPass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
•* Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC
•2. Normal tension glaucoma
•3. Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
•4. Severe glaucoma as documented in subjects' medical record per ICD-10 guidelines
•5. Use of oral hypotensive medication treatment for glaucoma
•6. In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications
+3 more criteria

Locations (15)

Eye Center South

Dothan, Alabama, United States

Barnet Delaney Perkins Eye Center

Lake Havasu City, Arizona, United States

Vold Vision

Fayetteville, Arkansas, United States

Your Eye Specialists

Weston, Florida, United States

Omni Eye Services

Atlanta, Georgia, United States

Eye Physicians and Surgeons, LLP

Iowa City, Iowa, United States

Grene Vision Group

Wichita, Kansas, United States

Vance Thompson Vision - MT

Bozeman, Montana, United States

Vance Thompson Vision - NE

Omaha, Nebraska, United States

Vance Thompson Vision - ND

West Fargo, North Dakota, United States

Key Dates

Start Date

March 11, 2019

Primary Completion Date

May 4, 2021

Completion Date

May 4, 2021

Last Updated

August 14, 2024

Enrollment

209

ACTUAL participants

Conditions

Open Angle Glaucoma

Interventions

Transluminal viscoelastic delivery and trabeculotomy

DEVICE

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

NCT07396441

Juvenile Open Angle GlaucomaDry Eye Disease (DED)+3 more

View study

RECRUITING

DSLT for Reducing Medication in Glaucoma

NCT07390890

Primary Open Angle GlaucomaOcular Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of OMNI System in OAG (GEMINI)

Inclusion Criteria

Exclusion Criteria

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

DSLT for Reducing Medication in Glaucoma

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

Effect of Rhopressa on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Post-SLT

Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma

Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes