Study of OMNI System in OAG (GEMINI) (NCT03861169) | Clinical Trial Compass
CompletedNot Applicable
Study of OMNI System in OAG (GEMINI)
United States209 participantsStarted 2019-03-11
Plain-language 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).
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Any of the following prior treatments for glaucoma:
. 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