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GORE Glaucoma Drainage Implant Clinical Study Dominican Republic

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment target: 20 to 30
    • Primary completion date: Jun 12, 2025 to Feb 12, 2027
    • Study completion date: Apr 2026 to Aug 2031
    • Study arms: 2 to 3
    v7
  2. Primary completion date changed from estimate of Sep 2025 to Jun 12, 2025v6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  4. Primary completion date: Sep 2024 to Sep 2025
    • Study completion date: Apr 2025 to Apr 2026
    • Study title expanded, about 2 words
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Primary completion date: Sep 2023 to Sep 2024
    • Study completion date: Apr 2024 to Apr 2025
    • Eligibility criteria shortened, about 342 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of several different GORE Glaucoma Drainage Implant configurations in subjects with primary open-angle glaucoma that is uncontrolled by hypotensive medications or for which conventional incisional glaucoma surgery would be more likely to fail due to scarring.
Trial Details
NCT Number NCT05557058
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Primary Open-angle Glaucoma
Related terms Glaucoma, Open-Angle
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov