Scleral Buckling for Retinal Detachment Prevention in Genetically Confirmed Stickler Syndrome (STL-DR-PREV)

February 6, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Scleral Buckling for Retinal Detachment Prevention in Genetically Confirmed Stickler Syndrome : a Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Stickler syndrome (STL) is a genetic disease affecting several organs. However the major risk is represented by the development of retinal detachment (RD). Up to 80% of patients present a RD and 25% to 80% have sequential bilateral RD. The surgical outcome of RD in this population is worse than that of the general RD population mainly because of the severity at diagnosis and the high frequency and severity of postoperative complications. Prevention has therefore emerged as a therapeutic option for this identifiable high-risk group of patients. Prevention has been proposed especially for the fellow (contralateral) eye of patients having presented a RD in their first eye and often lost vision as a consequence of retinal detachment in the first eye.

The investigators hypothesize that a scleral buckling surgical procedure performed for the fellow eye of STL patients having recently presented a RD of the first eye could prevent the occurrence of bilateral RD and/or vision loss.

Stickler patients are regularly diagnosed and followed-up in referral centers mainly in the context of a recent retinal detachment. They are proposed genetic testing as part of the standard of care. Genetically confirmed Stickler patients having recently presented (<24 months) a retinal detachment and treated as part of the standard care are eligible for this study. During the usual follow-up visits performed for their recent first RD operation they will be informed and offered to participate in the "STL-DR-PREV study" for the prevention of RD of their fellow eye.

Patients in the intervention arm will undergo an encircling scleral buckle surgical procedure, which is a routine surgical procedure used for decades and still in use to treat RD that will be performed in the present study to prevent rather than to treat retinal detachment from a healthy eye of a patient having a genetically confirmed Stickler Syndrome.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75014
        • Hopital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Sufficient patient cooperation to perform a complete ophthalmologic examination including a dilated fundus examination

Exclusion Criteria:

  • 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
  • Intraoperative detection of one or more of the above-mentioned non-inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental arm
Surgical procedure to prevent retinal detachment in the unaffected eye
Procedure: Encircling scleral buckle surgical procedure
Encircling scleral buckle surgical procedure under general anesthesia
NO_INTERVENTION: Control arm
Standard procedure of clinical practice without any surgical procedure for the unaffected fellow eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity and retinal detachment rate
Time Frame: 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of retinal breaks
Time Frame: 5 years
5 years
Rate of intravitreal hemorrhage
Time Frame: 5 years
5 years
Outcome in prevention-failed study eyes
Time Frame: 5 years
outcome of surgery for RD in the study eye of patients for whom prevention failed and had to be operated on for RD repair of the study eye
5 years
Effect of add-on cryotherapy
Time Frame: 5 years
To assess within the experimental arm whether patients having had cryotherapy as part (allowed by the protocol at the surgeon's discretion in addition to the standard procedure) of the scleral buckling procedure present a decrease in the rate of RD as compared to buckled patients without cryotherapy
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2023

Primary Completion (ANTICIPATED)

January 1, 2030

Study Completion (ANTICIPATED)

January 1, 2030

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (ACTUAL)

July 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P160948J
  • 2018-A01081-54 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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