CompletedNot Applicable

A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System

United States70 participantsStarted 2021-09-01

Plain-language summary

The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: • Participated in, received treatment, and completed Protocol #06213 Exclusion Criteria: * Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits * Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Safety Endpoint

Timeframe: 12 months

Trial details

NCT IDNCT05044793

SponsorSight Sciences, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-08-21

Results submitted2024-09-03

View on ClinicalTrials.gov More Glaucoma, Open-Angle trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.