Stickler SyndromePhase 2STL-DR-PREVNCT04465188
Scleral Buckling for Retinal Detachment Prevention in Genetically Confirmed Stickler Syndrome
A Phase 2 study testing Encircling scleral buckle surgical procedure in people with Stickler Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 35 years
- Conditions the study is for
- Stickler Syndrome
- What is being tested?
- Encircling scleral buckle surgical procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2023to Jun 2030
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 5 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- • 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
Show all 20Show fewer
- Any patient presenting an intraocular pressure during the inclusion visit (M-3) greater than 30 mm Hg
- 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
- Treatment with retinoids
- Hypersensitivity to the active substances or to any of the excipients of Chibrocadron®
- Personal or family history of glaucoma(Open angle primary glaucoma only)
- Intraoperative detection of one or more of the above-mentioned non-inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stickler Syndrome
- Being tested
- Encircling scleral buckle surgical procedure
- Keywords
- Stickler syndrome, Retinal detachment, Prophylaxis, Collagen
- Medical subject headings
- Stickler syndrome, type 1, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encircling scleral buckle surgical procedureProcedure or surgery
Encircling scleral buckle surgical procedure under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Surgical procedure to prevent retinal detachment in the unaffected eye Receives: Procedure: Encircling scleral buckle surgical procedure |
| Control arm | No intervention | Standard procedure of clinical practice without any surgical procedure for the unaffected fellow eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 years
Secondary outcomes (5)
Rate of retinal breaks
Measured: 5 years
Rate of intravitreal hemorrhage
Measured: 5 years
Outcome in prevention-failed study eyes
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
Measured: 5 years
Effect of add-on cryotherapy
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
Measured: 5 years
Safety of the experimental procedure
Safety issues related to the experimental surgical procedure will be reported and coded following MEDRA classification
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study startJun 2023 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Why it stopped: No inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stickler SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Antoine BREZIN, MD,Phd, Study director, Assistance Publique - Hôpitaux de ParisPierre-Raphael ROTHSHILD, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465188
- Sponsor's protocol ID
- P160948J
- Other IDs
- 2018-A01081-54
- Acronym
- STL-DR-PREV
- Status last verified
- Apr 2026
- First submitted
- 8 Jul 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8182253Abeysiri 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.
PubMed 17579881Carroll 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, 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.
PubMed 17675240Fincham 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 24793526
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleral Buckling for Retinal Detachment Prevention in Genetically Confirmed Stickler Syndrome : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04465188
- Acronym / sponsor ID
- STL-DR-PREV / P160948J
- Conditions
- Stickler Syndrome
- Keywords
- Stickler syndrome, Retinal detachment, Prophylaxis, Collagen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 9 Jul 2020 (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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: Encircling scleral buckle surgical procedureSurgical procedure to prevent retinal detachment in the unaffected eye |
| Control arm | No intervention | –Standard procedure of clinical practice without any surgical procedure for the unaffected fellow eye. |
Who may qualify
- Ages
- 5 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- • 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
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 |
|---|---|---|
| Encircling scleral buckle surgical procedureEncircling scleral buckle surgical procedure under general anesthesia | Procedure or surgery | Experimental arm |
Primary outcome
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 secondary outcomes
Rate of retinal breaks
Time frame: 5 years
Rate of intravitreal hemorrhage
Time frame: 5 years
Outcome in prevention-failed study eyes
Time frame: 5 years
Effect of add-on cryotherapy
Time frame: 5 years
Safety of the experimental procedure
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 8182253Monin 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.
- Background: PubMed 17579881Abeysiri 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.
- Background: PubMed 21466760Carroll 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.
- Background: PubMed 17675240Ang 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.
- 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.
- Individual participant dataSharing planned: No
Related trials for Stickler Syndrome
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Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
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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. This study is not recruiting at the moment.
Antoine BREZIN, MD,Phd study director
Assistance Publique - Hôpitaux de Paris
Pierre-Raphael ROTHSHILD, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Encircling scleral buckle surgical procedure in people with Stickler Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 20 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: withdrawn, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity and retinal detachment rate (time frame: 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 NCT04465188, which also lists 5 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 6 May 2026.