Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHelen Keller Eye Research Foundation
About this trial
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
Eligibility criteria
Qualifiers
No contraindications to laser retinopexy surgery per local site criteria.
Capable of giving signed informed consent, and assent (as appropriate)
Signature of research informed consent form from participant, or participant's legally authorized representative (LAR)/parent(s)/legal guardian
Male or female of any age
Disqualifiers
Presence of media opacity (for example, dense cataract, corneal scar) or poor pupillary dilation that precludes adequate OSC/SS performance, laser treatment, or imaging.
Prior prophylactic laser treatment that cannot be supplemented to achieve a complete OSC/SS pattern or exceeds the designated OSC/SS pattern.
RD in the eye to be treated.
Significant intraocular hemorrhage in the eye to be treated.
Trial design
Treatments tested in this trial
- Prophylactic (non-invasive) Laser Retinopexy
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Helen Keller Eye Research Foundation
Lead sponsor
Five Lakes Clinical Research Consulting, LLC
Collaborator
Source ClinicalTrials.gov