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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Helen Keller Eye Research Foundation
Study ID
NCT07146516
Status
Recruiting
Apply to this trial

Conditions

  • Stickler Syndrome Type 1
  • Stickler Syndrome Type 2

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prophylactic (non-invasive) Laser Retinopexy — PROCEDURE
    Prophylactic laser retinopexy to prevent RD in participants with SS using the indirect ophthalmoscopy (IDO) to place approximately 1500 to 2500 moderate intensity burns to produce encircling grid pattern, placed one burn width apart from 2 MM anterior to the ora serrata, extending to and between the vortex vein ampullae.

Study Details

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

Key Dates

Start date
Oct 30, 2025
Status verified
May 2026
Primary completion
Dec 31, 2035
Completion
Dec 31, 2035

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Children, Adolescents, and Adults with SS treated with Prophylactic Laser Retinopexy
    Intervention: Children, Adolescents, and Adults with SS treated with prophylactic laser retinopexy procedure.

Primary Outcome Measure

Number of Participants with SS who Develop RD After Undergoing the OSC/SS Procedure as Assessed by One of the Following Photographic Fundus Mapping and IDO Examinations [ Time Frame: From enrollment to post initial procedure at 5 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Retina Specialists of AlabamaBirminghamAlabama35233
Christina Sullivan
[email protected]
205-913-6213
Mathew Sapp, MD (PRINCIPAL_INVESTIGATOR)
Associated Retinal Consultants, P.C.Royal OakMichigan48073
Naina Desai, B.A.
[email protected]
248-288-9132
Matthew Trese, D.O. (PRINCIPAL_INVESTIGATOR)
Retina Consultants of MinnesotaMinneapolisMinnesota55435
Mallorie Schieck, CST
[email protected]
952-259-6262
Peter J Belin, MD (PRINCIPAL_INVESTIGATOR)
Long Island Vitreoretinal Consultants, PCWestburyNew York11590
Ewelina Lokaj
[email protected]
516-466-0390
Philip Ferrone, MD (PRINCIPAL_INVESTIGATOR)
Tennessee Retina, P.C.NashvilleTennessee37203
Lisa Walden, MA, OSC
[email protected]
615-345-8912
Franco Recchia, MD (PRINCIPAL_INVESTIGATOR)

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Retina Specialists of Alabama· Birmingham, ALAssociated Retinal Consultants, P.C.· Royal Oak, MIRetina Consultants of Minnesota· Minneapolis, MNLong Island Vitreoretinal Consultants, PC· Westbury, NYTennessee Retina, P.C.· Nashville, TN

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