Stickler Syndrome Type 1OSC/SSNCT07146516
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
A study testing Prophylactic (non-invasive) Laser Retinopexy in people with Stickler Syndrome Type 1 and Stickler Syndrome Type 2, run by Helen Keller Eye Research Foundation at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stickler Syndrome Type 1, Stickler Syndrome Type 2
- What is being tested?
- Prophylactic (non-invasive) Laser Retinopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Oct 2025to Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- SS type 1 or type 2 confirmed by genetic testing
Who cannot join
- 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.
- Uncontrolled ocular conditions (e.g., glaucoma) that may be worsened by the procedure or preclude follow-up.
- Any other ocular condition that precludes the ability to perform adequate laser treatment under scleral depression.
Show all 21Show fewer
- Any systemic medical contraindication where the risk of intervention outweighs the potential benefit.
- Known pathogenic mutations in genes associated with other inherited retinal detachment syndromes, including but not limited to: FEVR-related genes: FZD4, LRP5, TSPAN12, NDPX-linked retinoschisis (RS1) Wagner Syndrome (VCAN).
- Other syndromes associated with increased risk of retinal detachment (for example, Knobloch syndrome, Marfan syndrome, Pierson syndrome).
- History of Coats disease.
- History of Retinopathy of Prematurity (with or without laser treatment).
- Prior laser photocoagulation in the study eye for any indication other than the following: retinal detachment prophylaxis for Stickler syndrome, treatment of lattice degeneration, or treatment of retinal tears.
- Laser photocoagulation, for the indications permitted in exclusion criteria 12, that cannot be supplemented to meet the OSC/SS criteria.
- Previous cryopexy.
- Previous scleral buckle.
- Previous vitrectomy in the study eye for any reason.
- Significant peripheral retinal pathology unrelated to Stickler that increases the risk of retinal detachment including but not limited to: retinoschisis, hemorrhages, angiomatous lesions, pars planitis.
- History of ocular trauma with significant trauma to the posterior segment of the eye and may increase the risk of retinal detachment including Ruptured globe, Vitreous hemorrhage, Commotio retinae, Traumatic macular hole, Intraocular foreign body.
- Inability or unwillingness to comply with required follow-up schedule (clinical visits, imaging).
- Anticipated relocation, foster care instability, or any factor significantly limiting longitudinal follow-up.
- Investigator judgment: Any condition not listed above that could interfere with the trial's integrity or subject safety.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Five Lakes Clinical Research Consultants, LLC contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Retina Specialists of Alabama
Birmingham, Alabama, 35233
Christina Sullivan, 205-913-6213, csullivan@helenkellerfoundation.org
Mathew Sapp, MD
- Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Macarena Fuentes, MD, 857-289-2543, macarena.fuentes@childrens.harvard.edu
Nimesh Patel, MD
- Recruiting
Retina Consultants of Minnesota
Minneapolis, Minnesota, 55435
Mallorie Schieck, CST, 952-259-6262, MSchieck@RetinaMN.com
Peter J Belin, MD
- Recruiting
Tennessee Retina, P.C.
Nashville, Tennessee, 37203
Lisa Walden, MA, OSC, 615-345-8912, LWalden@tnretina.com
Franco Recchia, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Suzy Wernimont, 507-538-8119, Wernimont.suzanne@mayo.edu
Brittni Scruggs, MD, PHD
- Recruiting
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, 48073
Naina Desai, B.A., 248-288-9132 ext. 1315, ndesai@arcpc.net
Matthew Trese, D.O.
About this study
Official title: Ora Secunda Cerclage Laser Retinopexy To Prevent Retinal Detachment In Stickler Syndrome (OSC/SS): A Prospective Historically Controlled Study
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
Read the detailed description
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.
- Conditions
- Stickler Syndrome Type 1, Stickler Syndrome Type 2
- Being tested
- Prophylactic (non-invasive) Laser Retinopexy
- Keywords
- prophylactic laser retinopexy, Ora Secunda Cerclage, laser, prophylactic, retinopexy, Stickler syndrome, retinal detachment, retinal tear, Stickler syndrome type 2, giant retinal tear, encircling laser prevention, Stickler syndrome type 1, GRT
- Medical subject headings
- Stickler syndrome, type 1, Stickler syndrome, type 2, Retinal Detachment, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic (non-invasive) Laser RetinopexyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Children, Adolescents, and Adults with SS treated with Prophylactic Laser Retinopexy | Experimental | Intervention: Children, Adolescents, and Adults with SS treated with prophylactic laser retinopexy procedure. Receives: Procedure: Prophylactic (non-invasive) Laser Retinopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to post initial procedure at 5 years
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 to 6 months post OSC/SS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start30 Oct 2025
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Stickler Syndrome Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helen Keller Eye Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Five Lakes Clinical Research Consulting, LLC
- Responsible party
- Sponsor
- Investigators
- Robert E Morris, MD, Study director, Helen Keller Eye Research FoundationPeter J Belin, MD, Principal investigator, Retina Consultants of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146516
- Sponsor's protocol ID
- OSC/SS
- Acronym
- OSC/SS
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the trial, after deidentification.
Publications
Linton E, Jalil A, Sergouniotis P, Moussa G, Black G, Charles S, Ivanova T. LASER PROPHYLAXIS IN STICKLER SYNDROME: The Manchester Protocol. Retina. 2023 Jan 1;43(1):88-93. doi: 10.1097/IAE.0000000000003634.
PubMed 36165842Kim SJ, Bailey ST, Kovach JL, Lim JI, Vemulakonda GA, Ying GS, Flaxel CJ; American Academy of Ophthalmology Preferred Practice Pattern Retina/Vitreous Committee. Posterior Vitreous Detachment, Retinal Breaks, and Lattice Degeneration Preferred Practice Pattern(R). Ophthalmology. 2025 Apr;132(4):P163-P196. doi: 10.1016/j.ophtha.2024.12.023. Epub 2025 Feb 7. No abstract available.
PubMed 39918519Camp DA, Bakhsh SR, Torkashvand A, Jensen NR, Naravane AV, Belin PJ, Quiram PA, Ivanova T, Wubben TJ, Besirli CG, Bohnsack BL, Shapiro MJ, Blair MP, Hajrasouliha AR. Laser prophylaxis for retinal detachment in Stickler syndrome: A systematic review and meta-analysis. Acta Ophthalmol. 2025 Sep;103(6):e364-e373. doi: 10.1111/aos.17509. Epub 2025 May 15.
PubMed 40370211Gocuk SA, Shahzad A, Ayton L, Dawkins RCH, Ruddle JB. Paediatric glaucoma in Stickler syndromes: a comprehensive review of prevalence, comorbidities and outcomes. BMJ Open Ophthalmol. 2025 May 27;10(1):e002138. doi: 10.1136/bmjophth-2025-002138.
PubMed 40436442Fujimoto K, Nagata T, Matsushita I, Oku K, Imagawa M, Kuniyoshi K, Hayashi T, Kimoto K, Ohji M, Kusaka S, Kondo H. ULTRA-WIDE FIELD FUNDUS AUTOFLUORESCENCE IMAGING OF EYES WITH STICKLER SYNDROME. Retina. 2021 Mar 1;41(3):638-645. doi: 10.1097/IAE.0000000000002879.
PubMed 32639332Naravane AV, Belin PJ, Quiram PA. Retinal Detachment Prophylaxis for Patients With Stickler Syndrome: A Survey of Pediatric Retinal Specialist Treatment Preferences. Ophthalmic Surg Lasers Imaging Retina. 2023 Feb;54(2):102-107. doi: 10.3928/23258160-20230119-01. Epub 2023 Feb 1.
PubMed 36780636Morris RE, Parma ES, Robin NH, Sapp MR, Oltmanns MH, West MR, Fletcher DC, Schuchard RA, Kuhn F. Stickler Syndrome (SS): Laser Prophylaxis for Retinal Detachment (Modified Ora Secunda Cerclage, OSC/SS). Clin Ophthalmol. 2021 Jan 6;15:19-29. doi: 10.2147/OPTH.S284441. eCollection 2021.
PubMed 33447008Fincham GS, Pasea L, Carroll C, McNinch AM, Poulson AV, Richards AJ, Scott JD, Snead MP. Prevention of retinal detachment in Stickler syndrome: the Cambridge prophylactic cryotherapy protocol. Ophthalmology. 2014 Aug;121(8):1588-97. doi: 10.1016/j.ophtha.2014.02.022. Epub 2014 May 1.
PubMed 24793526Morris RE, Kuhn F, Richardson C. Preventing Retinal Detachment: The Encircling Laser Retinopexy Technique. Clin Ophthalmol. 2023 May 30;17:1505-1513. doi: 10.2147/OPTH.S406337. eCollection 2023.
PubMed 37273500Naravane AV, Belin PJ, Pierce B, Quiram PA. Risk and Prevention of Retinal Detachments in Patients with Stickler Syndrome. Ophthalmic Surg Lasers Imaging Retina. 2022 Jan;53(1):7-11. doi: 10.3928/23258160-20211213-02. Epub 2022 Jan 1.
PubMed 34982001Khanna S, Rodriguez SH, Blair MA, Wroblewski K, Shapiro MJ, Blair MP. Laser Prophylaxis in Patients with Stickler Syndrome. Ophthalmol Retina. 2022 Apr;6(4):263-267. doi: 10.1016/j.oret.2021.11.001. Epub 2021 Nov 11.
PubMed 34774838Parma ES, Korkko J, Hagler WS, Ala-Kokko L. Radial perivascular retinal degeneration: a key to the clinical diagnosis of an ocular variant of Stickler syndrome with minimal or no systemic manifestations. Am J Ophthalmol. 2002 Nov;134(5):728-34. doi: 10.1016/s0002-9394(02)01646-x.
PubMed 12429250Morris RE, Kuhn F, Sipos T. Preventing Retinal Detachment: Where are We? Implications from Stickler Syndrome. Clin Ophthalmol. 2022 Dec 23;16:4315-4321. doi: 10.2147/OPTH.S388631. eCollection 2022.
PubMed 36583093Carroll C, Papaioannou D, Rees A, Kaltenthaler E. The clinical effectiveness and safety of prophylactic retinal interventions to reduce the risk of retinal detachment and subsequent vision loss in adults and children with Stickler syndrome: a systematic review. Health Technol Assess. 2011 Apr;15(16):iii-xiv, 1-62. doi: 10.3310/hta15160.
PubMed 21466760Ang A, Ung T, Puvanachandra N, Wilson L, Howard F, Ryalls M, Richards A, Meredith S, Laidlaw M, Poulson A, Scott J, Snead M. Vitreous phenotype: a key diagnostic sign in Stickler syndrome types 1 and 2 complicated by double heterozygosity. Am J Med Genet A. 2007 Mar 15;143A(6):604-7. doi: 10.1002/ajmg.a.31527.
PubMed 17318849
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ora Secunda Cerclage Laser Retinopexy To Prevent Retinal Detachment In Stickler Syndrome (OSC/SS): A Prospective Historically Controlled Study
- ClinicalTrials.gov ID
- NCT07146516
- Acronym / sponsor ID
- OSC/SS / OSC/SS
- Conditions
- Stickler Syndrome Type 1, Stickler Syndrome Type 2
- Keywords
- prophylactic laser retinopexy, Ora Secunda Cerclage, laser, prophylactic, retinopexy, Stickler syndrome, retinal detachment, retinal tear
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Helen Keller Eye Research FoundationUniversity, hospital or other
- Collaborators
- Five Lakes Clinical Research Consulting, LLC
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children, Adolescents, and Adults with SS treated with Prophylactic Laser Retinopexy | Experimental | Procedure: Prophylactic (non-invasive) Laser RetinopexyIntervention: Children, Adolescents, and Adults with SS treated with prophylactic laser retinopexy procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- SS type 1 or type 2 confirmed by genetic testing
Key exclusion criteria (21 listed)
- 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.
- Uncontrolled ocular conditions (e.g., glaucoma) that may be worsened by the procedure or preclude follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic (non-invasive) Laser RetinopexyProphylactic 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. | Procedure or surgery | Children, Adolescents, and Adults with SS treated with Prophylactic Laser Retinopexy |
Primary outcome
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
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.
7 secondary outcomes
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)
Time frame: From enrollment to post initial procedure at 5 years
Size of Retinal Defects
Time frame: From enrollment to post initial procedure at 5 years
Number of Occurrences of Retinal Defects
Time frame: From enrollment to post initial procedure at 5 years
Number of Participants Experiencing Retinal Defects
Time frame: From enrollment to post initial procedure at 5 years
Number of Surgeries to Repair Retinal Detachments or Retinal Defects
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
Time frame: From enrollment to post initial procedure at 5 years
Number of Procedure Deviations by Treating Physicians as Assessed by Photographic Fundus Mapping
Time frame: 3 to 6 months post OSC/SS procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 36165842Linton E, Jalil A, Sergouniotis P, Moussa G, Black G, Charles S, Ivanova T. LASER PROPHYLAXIS IN STICKLER SYNDROME: The Manchester Protocol. Retina. 2023 Jan 1;43(1):88-93. doi: 10.1097/IAE.0000000000003634.
- Background: PubMed 39918519Kim SJ, Bailey ST, Kovach JL, Lim JI, Vemulakonda GA, Ying GS, Flaxel CJ; American Academy of Ophthalmology Preferred Practice Pattern Retina/Vitreous Committee. Posterior Vitreous Detachment, Retinal Breaks, and Lattice Degeneration Preferred Practice Pattern(R). Ophthalmology. 2025 Apr;132(4):P163-P196. doi: 10.1016/j.ophtha.2024.12.023. Epub 2025 Feb 7. No abstract available.
- Background: PubMed 40370211Camp DA, Bakhsh SR, Torkashvand A, Jensen NR, Naravane AV, Belin PJ, Quiram PA, Ivanova T, Wubben TJ, Besirli CG, Bohnsack BL, Shapiro MJ, Blair MP, Hajrasouliha AR. Laser prophylaxis for retinal detachment in Stickler syndrome: A systematic review and meta-analysis. Acta Ophthalmol. 2025 Sep;103(6):e364-e373. doi: 10.1111/aos.17509. Epub 2025 May 15.
- Background: PubMed 40436442Gocuk SA, Shahzad A, Ayton L, Dawkins RCH, Ruddle JB. Paediatric glaucoma in Stickler syndromes: a comprehensive review of prevalence, comorbidities and outcomes. BMJ Open Ophthalmol. 2025 May 27;10(1):e002138. doi: 10.1136/bmjophth-2025-002138.
- Background: PubMed 32639332Fujimoto K, Nagata T, Matsushita I, Oku K, Imagawa M, Kuniyoshi K, Hayashi T, Kimoto K, Ohji M, Kusaka S, Kondo H. ULTRA-WIDE FIELD FUNDUS AUTOFLUORESCENCE IMAGING OF EYES WITH STICKLER SYNDROME. Retina. 2021 Mar 1;41(3):638-645. doi: 10.1097/IAE.0000000000002879.
- Background: PubMed 36780636Naravane AV, Belin PJ, Quiram PA. Retinal Detachment Prophylaxis for Patients With Stickler Syndrome: A Survey of Pediatric Retinal Specialist Treatment Preferences. Ophthalmic Surg Lasers Imaging Retina. 2023 Feb;54(2):102-107. doi: 10.3928/23258160-20230119-01. Epub 2023 Feb 1.
- Background: PubMed 33447008Morris RE, Parma ES, Robin NH, Sapp MR, Oltmanns MH, West MR, Fletcher DC, Schuchard RA, Kuhn F. Stickler Syndrome (SS): Laser Prophylaxis for Retinal Detachment (Modified Ora Secunda Cerclage, OSC/SS). Clin Ophthalmol. 2021 Jan 6;15:19-29. doi: 10.2147/OPTH.S284441. eCollection 2021.
- Background: PubMed 24793526Fincham GS, Pasea L, Carroll C, McNinch AM, Poulson AV, Richards AJ, Scott JD, Snead MP. Prevention of retinal detachment in Stickler syndrome: the Cambridge prophylactic cryotherapy protocol. Ophthalmology. 2014 Aug;121(8):1588-97. doi: 10.1016/j.ophtha.2014.02.022. Epub 2014 May 1.
- Background: PubMed 37273500Morris RE, Kuhn F, Richardson C. Preventing Retinal Detachment: The Encircling Laser Retinopexy Technique. Clin Ophthalmol. 2023 May 30;17:1505-1513. doi: 10.2147/OPTH.S406337. eCollection 2023.
- Background: PubMed 34982001Naravane AV, Belin PJ, Pierce B, Quiram PA. Risk and Prevention of Retinal Detachments in Patients with Stickler Syndrome. Ophthalmic Surg Lasers Imaging Retina. 2022 Jan;53(1):7-11. doi: 10.3928/23258160-20211213-02. Epub 2022 Jan 1.
- Background: PubMed 34774838Khanna S, Rodriguez SH, Blair MA, Wroblewski K, Shapiro MJ, Blair MP. Laser Prophylaxis in Patients with Stickler Syndrome. Ophthalmol Retina. 2022 Apr;6(4):263-267. doi: 10.1016/j.oret.2021.11.001. Epub 2021 Nov 11.
- Background: PubMed 12429250Parma ES, Korkko J, Hagler WS, Ala-Kokko L. Radial perivascular retinal degeneration: a key to the clinical diagnosis of an ocular variant of Stickler syndrome with minimal or no systemic manifestations. Am J Ophthalmol. 2002 Nov;134(5):728-34. doi: 10.1016/s0002-9394(02)01646-x.
- Equator Network. Consolidated Standards of Reporting Trials (CONSORT). Equator Network. 2010. Available at URL provided. Accessed November 29, 2024.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Five Lakes Clinical Research Consultants, LLC contact
Robert E Morris, MD study director
Helen Keller Eye Research Foundation
Peter J Belin, MD principal investigator
Retina Consultants of Minnesota
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic (non-invasive) Laser Retinopexy in people with Stickler Syndrome Type 1 and Stickler Syndrome Type 2, run by Helen Keller Eye Research Foundation at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter J Belin, MD (952-929-1131, drbelin@retinamn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07146516, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.