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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Prophylactic (non-invasive) Laser Retinopexy
Procedure/SurgeryProphylactic 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Children, Adolescents, and Adults with SS treated with Prophylactic Laser RetinopexyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Helen Keller Eye Research Foundation
Lead sponsor
Five Lakes Clinical Research Consulting, LLC
Collaborator
Source ClinicalTrials.gov