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Device
Viscoeleastic delivery & trabeculotomy for Open-Angle Glaucoma
N/A
Recruiting
Research Sponsored by Sight Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subjects, 22 years or older.
Visually significant cataract
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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).
Eligible Conditions
- Open-Angle Glaucoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mean number of IOP-lowering medications
Change in mean unmedicated diurnal IOP
Secondary outcome measures
Percent of eyes with a ≥20% reduction in unmedicated diurnal IOP at 12 months
Percent of eyes with unmedicated diurnal IOP between 6 and 18 mmHg inclusive at 12 months
Other outcome measures
Safety Endpoint- Adverse events
Safety Endpoint- best corrected visual acuity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Viscoeleastic delivery & trabeculotomyExperimental Treatment1 Intervention
Patients with open angle glaucoma and cataract
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Who is running the clinical trial?
Sight Sciences, Inc.Lead Sponsor
12 Previous Clinical Trials
795 Total Patients Enrolled
kavita p dhamdhere, MD, PhDStudy DirectorSight Sciences
Frequently Asked Questions
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