A Clinical Study To Assess The Safety And Effectiveness Of The OMNIĀ® Surgical System (NCT05044793) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study To Assess The Safety And Effectiveness Of The OMNIĀ® 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 OMNIĀ® Surgical System in subjects who were treated under protocol #06213
Who can participate
SexALL
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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)