Study of OMNI System in OAG (GEMINI)

NCT ID: NCT03861169

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2021-05-04

Brief 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.

Conditions

Open Angle Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Viscoeleastic delivery & trabeculotomy

Patients with open angle glaucoma and cataract

Group Type: EXPERIMENTAL

Transluminal viscoelastic delivery and trabeculotomy

Intervention Type: DEVICE

Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System

Interventions

Transluminal viscoelastic delivery and trabeculotomy

Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System

Intervention Type: DEVICE

Eligibility Criteria

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.

10. Understood and signed the informed consent

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

7. Ocular pathology or medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)

8. Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator

9. Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sight Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaime Dickerson, PhD

Role: STUDY_DIRECTOR

Sight Sciences

Locations

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

Oklahoma Eye Surgeons

Oklahoma City, Oklahoma, United States

Northern Ophthalmics

Jenkintown, Pennsylvania, United States

El Paso Eye Surgeons

El Paso, Texas, United States

Ophthalmology Associates

Fort Worth, Texas, United States

Eye Centers of Racine and Kenosha

Kenosha, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

06213

Identifier Type: -

Identifier Source: org_study_id