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Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)

Study acronym: OSC/SS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites revised (5)v9
  2. Study sites: 4 to 5
    • Eligibility criteria expanded, about 9 words
    v8
  3. Study sites: 2 to 4v7
  4. Publications revised (29)
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 3 words
    v6
  5. Site details revised at 1 of 2 sitesv5
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  1. Study sites: 1 to 2v4
  2. Start date changed from estimate of Oct 2025 to Oct 30, 2025v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Study sites: 0 to 1
    • Start date: Sep 2025 to Oct 2025
    • Eligibility criteria expanded, about 261 words
    • Secondary endpoints revised (7)
    • Study description expanded, about 38 words
    • Publications: 25 to 29
    • Study title expanded, about 1 word
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to prospectively document to what extent the OSC/SS prophylactic laser retinopexy procedure works to prevent retinal detachment in SS in children and adults. Researchers will compare the OSC/SS procedure in SS to the natural progression of SS to see to what extent the OSC/SS procedure works to prevent retinal detachment. Participants will: * Have the OSC/SS procedure in one or both eyes * Have eye tests * Have genetic testing for SS as needed * Visit the study center 9 times over 5 years for checkups and tests * Have data for the untreated fellow-eye collected and used as study data if available
Trial Details
NCT Number NCT07146516
Lead Sponsor Helen Keller Eye Research Foundation
Collaborators: Five Lakes Clinical Research Consulting, LLC
Conditions
(from sponsor)		 Stickler Syndrome Type 1, Stickler Syndrome Type 2
Related terms Retinal Detachment, Retinal Perforations, Stickler syndrome, type 1, Stickler syndrome, type 2
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov