Scleral Buckling for Retinal Detachment Prevention in Genetically Confirmed Stickler Syndrome

NCT04465188 | Withdrawn Phase 2

• 2 other identifiers: P160948J2018-A01081-54
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a scleral buckling surgical procedure performed on fellow eyes of patients with genetically confirmed Stickler syndrome can prevent the occurrence retinal detachment and/or severe vision loss of the study eye.

Conditions

Stickler Syndrome

Keywords

Stickler syndrome; Retinal detachment; Prophylaxis; Collagen

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity and retinal detachment rate

  Early Treatment Diabetic Retinopathy Study (ETRDS) best corrected visual acuity (BCVA) and dilated funduscopic examinations at scheduled follow-up (every 6 months)

  5 years

Secondary Outcomes (5)

• Rate of retinal breaks

  5 years

• Rate of intravitreal hemorrhage

  5 years

• Outcome in prevention-failed study eyes

  5 years

• Effect of add-on cryotherapy

  5 years

• Safety of the experimental procedure

  5 years

Study Arms (2)

Experimental arm

EXPERIMENTAL

Surgical procedure to prevent retinal detachment in the unaffected eye

Procedure: Encircling scleral buckle surgical procedure

Control arm

NO INTERVENTION

Standard procedure of clinical practice without any surgical procedure for the unaffected fellow eye.

Interventions

Encircling scleral buckle surgical procedure PROCEDURE

Encircling scleral buckle surgical procedure under general anesthesia

Experimental arm

Eligibility Criteria

• Age: 5 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Genetically confirmed Stickler Syndrome
• Aged 5 to 35
• Recent retinal detachment in the non-study eye (\<24 months)
• Signed informed consent to participate in the study; For the minors, information and consent of the holders of parental authority
• Sufficient patient cooperation to perform a complete ophthalmologic examination including a dilated fundus examination
• Patients affiliated with social security or CMU (profit or being entitled)

You may not qualify if:

• Any type of previous prevention (laser, cryotherapy, scleral buckle) for the study eye
• Subclinical retinal rhegmatogenous detachment in the study eye.
• Any other ocular disease unrelated to Stickler syndrome significantly affecting visual acuity (ETDRS BCVA\<20/400).
• Contraindications to general anesthesia
• Posterior vitreoretinal traction on optical coherence tomography
• Pregnant or breastfeeding women
• Hypersensitivity to povidone iodine, iodine or any of the excipients of the specialty used
• Hypersensitivity to acetazolamide or any of the excipients of the specialty used
• Severe hepatic, renal or adrenal insufficiency
• Sulfonamide intolerance
• History of renal colic
• Pre-existing plasma hyperosmolarity
• Predominantly intracellular dehydration
• Hypersensitivity to dexamethasone or any of the excipients of the specialty used
• Hypersensitivity to oxytetracycline or to any of the excipients of Sterdex

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

Related Publications (5)

• Monin C, Van Effenterre G, Andre-Sereys P, Haut J. [Prevention of retinal detachment in Wagner-Stickler disease. Comparative study of different methods. Apropos of 22 cases]. J Fr Ophtalmol. 1994;17(3):167-74. French.

  PMID: 8182253 BACKGROUND

• Abeysiri P, Bunce C, da Cruz L. Outcomes of surgery for retinal detachment in patients with Stickler syndrome: a comparison of two sequential 20-year cohorts. Graefes Arch Clin Exp Ophthalmol. 2007 Nov;245(11):1633-8. doi: 10.1007/s00417-007-0609-2. Epub 2007 Jun 20.

  PMID: 17579881 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, 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

• 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

MeSH Terms

Conditions

Stickler syndrome, type 1; Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Antoine BREZIN, MD,Phd

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Pierre-Raphael ROTHSHILD, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 9, 2020
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)