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

NCT07146516 | Recruiting

• 1 other identifier: OSC/SS
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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. 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

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; Stickler syndrome type 2; giant retinal tear; encircling laser prevention; Stickler syndrome type 1; GRT

Outcome Measures

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.

  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)

  From enrollment to post initial procedure at 5 years

• Size of Retinal Defects

  From enrollment to post initial procedure at 5 years

• Number of Occurrences of Retinal Defects

  From enrollment to post initial procedure at 5 years

• Number of Participants Experiencing Retinal Defects

  From enrollment to post initial procedure at 5 years

• Number of Surgeries to Repair Retinal Detachments or Retinal Defects

  From enrollment to post initial procedure at 5 years

Study Arms (1)

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.

Procedure: Prophylactic (non-invasive) Laser Retinopexy

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.

Children, Adolescents, and Adults with SS treated with Prophylactic Laser Retinopexy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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).
• Previous laser photocoagulation in the study eye for any indication, including Retinopathy of prematurity (ROP) Panretinal photocoagulation for diabetic retinopathy.
• Laser to lattice degeneration or 360-degree laser cerclage for Stickler Syndrome that cannot be supplemented to meet OSC/SS criteria.
• Previous cryopexy.
• Previous scleral buckle.

Sponsors & Collaborators

• Helen Keller Eye Research Foundation: lead
• Five Lakes Clinical Research Consulting, LLC: collaborator

Study Sites (2)

Retina Specialists of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

Retina Consultants of Minnesota

Minneapolis, Minnesota, 55435, United States

RECRUITING

Related Publications (28)

• 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.

  PMID: 36165842 BACKGROUND

• Kim 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.

  PMID: 39918519 BACKGROUND

• Camp 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.

  PMID: 40370211 BACKGROUND

• Gocuk 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.

  PMID: 40436442 BACKGROUND

• Fujimoto 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.

  PMID: 32639332 BACKGROUND

• Naravane 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.

  PMID: 36780636 BACKGROUND

• Morris 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.

  PMID: 33447008 BACKGROUND

• Fincham 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.

  PMID: 24793526 BACKGROUND

• Morris 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.

  PMID: 37273500 BACKGROUND

• Naravane 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.

  PMID: 34982001 BACKGROUND

• Khanna 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.

  PMID: 34774838 BACKGROUND

• Parma 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.

  PMID: 12429250 BACKGROUND

• Morris 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.

  PMID: 36583093 BACKGROUND

• Carroll 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.

  PMID: 21466760 BACKGROUND

• Ang 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.

  PMID: 17318849 BACKGROUND

• Boysen KB, La Cour M, Kessel L. Ocular complications and prophylactic strategies in Stickler syndrome: a systematic literature review. Ophthalmic Genet. 2020 Jun;41(3):223-234. doi: 10.1080/13816810.2020.1747092. Epub 2020 Apr 21.

  PMID: 32316871 BACKGROUND

• Snead MP, McNinch AM, Poulson AV, Bearcroft P, Silverman B, Gomersall P, Parfect V, Richards AJ. Stickler syndrome, ocular-only variants and a key diagnostic role for the ophthalmologist. Eye (Lond). 2011 Nov;25(11):1389-400. doi: 10.1038/eye.2011.201. Epub 2011 Sep 16.

  PMID: 21921955 BACKGROUND

• Ang A, Poulson AV, Goodburn SF, Richards AJ, Scott JD, Snead MP. Retinal detachment and prophylaxis in type 1 Stickler syndrome. Ophthalmology. 2008 Jan;115(1):164-8. doi: 10.1016/j.ophtha.2007.03.059. Epub 2007 Aug 2.

  PMID: 17675240 BACKGROUND

• Reddy DN, Yonekawa Y, Thomas BJ, Nudleman ED, Williams GA. Long-term surgical outcomes of retinal detachment in patients with Stickler syndrome. Clin Ophthalmol. 2016 Aug 16;10:1531-4. doi: 10.2147/OPTH.S111526. eCollection 2016.

  PMID: 27574392 BACKGROUND

• Taylor K, Su M, Richards Z, Mamawalla M, Rao P, Chang E. Outcomes in Retinal Detachment Repair and Laser Prophylaxis for Syndromes with Optically Empty Vitreous. Ophthalmol Retina. 2023 Oct;7(10):848-856. doi: 10.1016/j.oret.2023.06.012. Epub 2023 Jun 23.

  PMID: 37356493 BACKGROUND

• Friberg TR. Clinical experience with a binocular indirect ophthalmoscope laser delivery system. Retina. 1987 Spring;7(1):28-31.

  PMID: 3602603 BACKGROUND

• Riffenburgh RH, Gillen DL. Statistics in medicine: Academic Press; 2020.

  BACKGROUND

• Verhoekx JSN, van Etten PG, Wubbels RJ, van Meurs JC, van Overdam KA. PROPHYLACTIC LASER TREATMENT TO DECREASE THE INCIDENCE OF RETINAL DETACHMENT IN FELLOW EYES OF IDIOPATHIC GIANT RETINAL TEARS. Retina. 2020 Jun;40(6):1094-1097. doi: 10.1097/IAE.0000000000002494.

  PMID: 30865062 BACKGROUND

• Morris RE, Sapp MR, Oltmanns MH, West MR. Correspondence. Retina. 2023 Sep 1;43(9):e52-e53. doi: 10.1097/IAE.0000000000003829. No abstract available.

  PMID: 37141590 BACKGROUND

• Alexander P, Fincham GS, Brown S, Collins D, McNinch AM, Poulson AV, Richards A, Martin H, Wareham N, Snead MP. Cambridge Prophylactic Protocol, Retinal Detachment, and Stickler Syndrome. N Engl J Med. 2023 Apr 6;388(14):1337-1339. doi: 10.1056/NEJMc2211320. No abstract available.

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• Hagler WS, Crosswell HH Jr. Radial perivascular chorioretinal degeneration and retinal detachment. Trans Am Acad Ophthalmol Otolaryngol. 1968 Mar-Apr;72(2):203-16. No abstract available.

  PMID: 5659901 BACKGROUND

• Khan AO, AlAbdi L, Patel N, Helaby R, Hashem M, Abdulwahab F, AlBadr FB, Alkuraya FS. Genetic testing results of children suspected to have Stickler syndrome type collagenopathy after ocular examination. Mol Genet Genomic Med. 2021 May;9(5):e1628. doi: 10.1002/mgg3.1628. Epub 2021 May 5.

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Related Links

• Equator Network. Consolidated Standards of Reporting Trials (CONSORT). Equator Network. 2010. Available at URL provided. Accessed November 29, 2024.
• Morris R, Witherspoon CD, Kuhn F, Sapp M. Retinal detachment laser prophylaxis (by invitation). Retina Today. 2008; 2008:63-66. \[Google Scholar\]

MeSH Terms

Conditions

Stickler syndrome, type 1; Stickler syndrome, type 2; Retinal Detachment; Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Robert E Morris, MD

  Helen Keller Eye Research Foundation

  STUDY DIRECTOR

• Peter J Belin, MD

  Retina Consultants of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter J Belin, MD

CONTACT

952-929-1131; drbelin@retinamn.com

Five Lakes Clinical Research Consultants, LLC

CONTACT

contactus@fivelakesconsultants.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 28, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (2)