Glaucoma, Open-Angle Clinical Trial
Official title:
A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)
NCT number | NCT05044793 |
Other study ID # | 07408 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 30, 2021 |
Est. completion date | August 21, 2023 |
Verified date | January 2024 |
Source | Sight Sciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 72 |
Est. completion date | August 21, 2023 |
Est. primary completion date | August 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | El Paso Eye Surgeons | El Paso | Texas |
United States | Northern Ophthalmics | Jenkintown | Pennsylvania |
United States | Oklahoma Eye Surgeons | Oklahoma City | Oklahoma |
United States | Grene Vision Group | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Sight Sciences, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in intraocular pressure (IOP) | Change in unmedicated mean diurnal IOP (DIOP) | 24months | |
Primary | Change in number of medications | Change in the number of ocular hypotensive medications | 24months |
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