An interventional study of Prophylactic (non-invasive) Laser Retinopexy in Stickler Syndrome Type 1 and Stickler Syndrome Type 2, sponsored by Helen Keller Eye Research Foundation. Recruiting at 6 sites in United States. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Helen Keller Eye Research Foundation · Not applicable, Interventional, and Prevention
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:
Prophylactic treatment for RD has been well-documented to be safe and effective for specific predisposing conditions, but parameters are not standardized and are poorly documented in the literature for Stickler syndrome. There is significant, but only retrospective, evidence in the scientific literature that non-invasive, encircling (360 degree) laser prophylaxis (cerclage prophylaxis) reduces the rate of retinal detachment in patients with Stickler syndrome by approximately five-fold. In February 2025, the American Academy of Ophthalmology (AAO) endorsed 360-degree cerclage laser prophylaxis for Stickler syndrome based on retrospective evidence. A statistical review of pertinent articles concluded that prophylactic laser therapy was associated with a significantly lower risk of retinal detachment in patients with Stickler syndrome compared to no laser prophylaxis. This clinical trial is designed to offer OSC/SS as the optimal form of such prevention, and to prospectively document, in a standardized manner, the extent to which it prevents retinal detachment in patients with Stickler syndrome.
This clinical trial aims to address the lack of standardized documentation in previous literature and studies by providing standardized treatment parameters and rigorously documenting the OSC/SS technique. By evaluating the safety and efficacy of OSC/SS in preventing RD in Stickler syndrome patients, this study seeks to establish a benchmark for future clinical practice and research.
The primary objective is to demonstrate the efficacy of the OSC/SS procedure compared to the natural progression of SS to prevent RD for individuals with SS. This comparison will be made using historical control data provided by Cambridge University, which documents the rate of occurrence of RD in the absence of prior prophylactic treatment. Cambridge University maintains a large SS database, consisting of decades of clinical and research data on Stickler syndrome populations, providing the necessary control raw data for this study population. If the OSC/SS procedure proves to be adequately successful in the study, then it may become the gold standard treatment used to prevent RD in patients with SS and, with modifications, other populations at high risk for RD.
Enrollment is competitive.
199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.
This study's planned enrollment of 500 is above the median of 50 across 132 interventional studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →This is the only study on the registry with Helen Keller Eye Research Foundation as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention: Children, Adolescents, and Adults with SS treated with prophylactic laser retinopexy procedure.
Procedure: Prophylactic (non-invasive) Laser Retinopexy
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.
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
Efficacy of the OSC/SS procedure in preventing RD in participants with type 1 (STL1) and type 2 (STL2) SS will be assessed annually by tracking the number of participants who develop RD after undergoing the OSC/SS procedure, using data from one of the following: photographic fundus mapping and IDO examinations.
Time frame: From enrollment to post initial procedure at 5 years
Frequency of Adverse Events as Assessed by Recurring Eye Evaluations (photographic fundus mapping, OCT, intraocular pressure, pupil measurements, slit lamp biomicroscopy, motility assessments, and vision acuity testing)
Annual evaluation of the safety of the OSC/SS procedure will be assessed by reviewing adverse events collected from recurring visual history and eye evaluations (photographic fundus mapping, OCT, intraocular pressure, pupil measurements, slit lamp biomicroscopy, motility assessments, and vision acuity testing).
Time frame: From enrollment to post initial procedure at 5 years
Size of Retinal Defects
Annually assess the size (measured in clock hours) of retinal defects including giant retinal tears (GRT) in participants experiencing retinal defects after undergoing the OSC/SS procedure, using IDO examinations compared to the natural course of SS.
Time frame: From enrollment to post initial procedure at 5 years
Number of Occurrences of Retinal Defects
Annually assess by tracking the number of occurrences of participants experiencing retinal defects including giant retinal tears after undergoing the OSC/SS procedure, using the number of unique retinal defect forms received for each participant.
Time frame: From enrollment to post initial procedure at 5 years
Number of Participants Experiencing Retinal Defects
Annually assess by tracking the number of participants experiencing retinal defects after undergoing the OSC/SS procedure, using data from one of the following: photographic fundus mapping and IDO examinations.
Time frame: From enrollment to post initial procedure at 5 years
Number of Surgeries to Repair Retinal Detachments or Retinal Defects
Annually assess by tracking the number of surgeries to repair retinal detachments or retinal defects in participants after undergoing the OSC/SS procedure, using the number of surgeries documented on the retinal defect forms received for each participant.
Time frame: From enrollment to post initial procedure at 5 years
Measurement of Visual Acuity in Participants with SS Before and After the OSC/SS Procedure as Assessed by Using Standard of Care Methods
Impact of the OSC/SS procedure on visual acuity in participants with SS will be measured by standard of care methods including visual acuity charts and optical coherence tomography (OCT) imaging of the macula.
Time frame: From enrollment to post initial procedure at 5 years
Number of Procedure Deviations by Treating Physicians as Assessed by Photographic Fundus Mapping
Evaluate the compliance of treating physicians in correctly performing the OSC/SS procedure on participants with SS by tracking the number of procedure deviations including protocol specified grid coverage, burn spacing, and burn intensity by conducting a central review of photographic fundus mapping.
Time frame: 3 to 6 months post OSC/SS procedure
Plan to share: Yes — Individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol
Time frame: Beginning 9 months after publication of primary outcomes, ending 5 years following article publication.
Access criteria: Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose. To achieve aims in the approved proposal. Proposals should be directed to lbeckwith@helenkellerfoundation.org. If proposals are approved after review by regulatory counsel, requestors will need to enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.
Started Oct 2025 (actual). Primary completion is estimated for Dec 2035, 122 months after the start.
Of 55 non-industry interventional studies with no phase under Retinal Detachment, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 49. This study's planned 122 months is above that.
Counting every sponsor, half of 56 studies reached it within 23 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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