Study of OMNI System in OAG (GEMINI)

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Only one eye of each subject was eligible (the "study eye"), and all ocular criteria listed below applied to the study eye.

Male or female subjects, 22 years or older
Visually significant cataract
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
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
At baseline, unmedicated diurnal IOP 21-36 mmHg and IOP at least 3 mmHg higher than screening IOP
Scheduled for cataract extraction followed by ab- interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System
Shaffer grade of ≥ 3 in all four quadrants
Potential of good best corrected visual acuity post cataract extraction, in the Investigator's judgment
Able and willing to comply with the protocol, including all follow-up visits.
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.

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
Normal tension glaucoma
Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Severe glaucoma as documented in subjects' medical record per ICD-10 guidelines
Use of oral hypotensive medication treatment for glaucoma
In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications
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)
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
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

Arm && Interventions

Group	Intervention	Description
Viscoeleastic delivery & trabeculotomy	Transluminal viscoelastic delivery and trabeculotomy	Patients with open angle glaucoma and cataract

Primary Outcome Measures

Name	Time	Method
Change in Mean Unmedicated Diurnal IOP	12 months	Change in mean unmedicated diurnal IOP from baseline to 12 months
Change in Mean Number of IOP-Lowering Medications	12 months	Reduction in mean number of IOP-lowering medications from screening to 12 months

Secondary Outcome Measures

Name	Time	Method
Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP	12 months	First Secondary Effectiveness endpoint/Percent of eyes with a ≥20% reduction in unmedicated DIOP at 12 months
Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months	12 months	Second Secondary Effectiveness Endpoint: Unmedicated DIOP ≥ 6 mmHg and ≤ 18 mmHg at 12 Months/Percent of eyes with unmedicated DIOP between 6 and 18 mmHg inclusive at 12 months

Locations (15): Vold Vision
🇺🇸
Fayetteville, Arkansas, United States
Eye Center South
🇺🇸
Dothan, Alabama, United States
Eye Physicians and Surgeons, LLP
🇺🇸
Iowa City, Iowa, United States
Northern Ophthalmics
🇺🇸
Jenkintown, Pennsylvania, United States
El Paso Eye Surgeons
🇺🇸
El Paso, Texas, United States
Ophthalmology Associates
🇺🇸
Fort Worth, Texas, United States
Vance Thompson Vision - ND
🇺🇸
W. Fargo, North Dakota, United States
Grene Vision Group
🇺🇸
Wichita, Kansas, United States
Oklahoma Eye Surgeons
🇺🇸
Oklahoma City, Oklahoma, United States
Barnet Delaney Perkins Eye Center
🇺🇸
Lake Havasu City, Arizona, United States
Omni Eye Services
🇺🇸
Atlanta, Georgia, United States
Vance Thompson Vision - NE
🇺🇸
Omaha, Nebraska, United States
Your Eye Specialists
🇺🇸
Weston, Florida, United States
Eye Centers of Racine and Kenosha
🇺🇸
Kenosha, Wisconsin, United States
Vance Thompson Vision - MT
🇺🇸
Bozeman, Montana, United States