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Eye surgery trial to prevent blindness in stickler syndrome pulled before start

NCT ID NCT04465188

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if a surgical procedure called scleral buckling could prevent retinal detachment in people with Stickler syndrome, a genetic condition that raises the risk of vision loss. The plan was to treat one eye in patients aged 5 to 35 who had already lost vision in the other eye. However, the trial was withdrawn before enrolling any participants, so no conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
scleral buckle surgical procedure
What this could lead to
If it had worked, this could have pointed toward a way to prevent retinal detachment and vision loss in people with Stickler syndrome.
What could go wrong
The trial was withdrawn before it started, so no results are available. Even if it had run, it was a small early-phase study, and surgery carries risks like infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Jun 2023

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 35 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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; 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) 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 * Pregnant or breastfeeding women * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hôpital Cochin

    Paris, 75014, France