Using freeze-dried amniotic membrane after corneal crosslinking for keratoconus

Multicenter, Randomized Study Evaluating the Use of a Non-sutured Sterile Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus

This study is testing if applying a freeze-dried amniotic membrane to the eye after corneal crosslinking can help people with keratoconus feel less pain and heal better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: TBF Genie Tissulaire (Industry-sponsored)
• Locations: 9 sites (Brest and 8 other locations)
• Trial ID: NCT06450470 on ClinicalTrials.gov

What this trial studies

This multicenter randomized study aims to evaluate the effectiveness of applying a freeze-dried amniotic membrane to the eye following crosslinking treatment for progressive keratoconus. Crosslinking is a procedure designed to strengthen the cornea and halt its deterioration, but it often results in postoperative pain due to the removal of the corneal epithelium. The amniotic membrane is known for its healing and pain-relieving properties, and this study will compare outcomes between patients receiving standard care and those receiving the amniotic membrane treatment. The goal is to assess whether the membrane can reduce pain and enhance corneal healing post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with progressive keratoconus requiring crosslinking treatment.

Not a fit: Patients who have previously undergone crosslinking or are pregnant/breastfeeding will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative pain and improve recovery for patients undergoing crosslinking for keratoconus.

How similar studies have performed: While the use of amniotic membrane in ophthalmology has been explored, this specific application post-crosslinking is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Man or woman between 18 and 65 years old.
* Indication for accelerated conventional crosslinking.
* Patient with progressive keratoconus (increase in Kmax of ≥ 0.5 diopters in 3 to 6 months or ≥ 1 diopter in 3 to 12 months with loss of 10 microns on minimum pachymetry in 3 to 12 month).
* Patient suffering from keratoconus with a compatible topographic form (Kmax ≥ 47.0 diopters (D) and difference inferior-superior of 1.5 D).
* Patient with a minimum corneal thickness greater than 400 microns.
* Informed and consenting patient.
* Patient physically and mentally capable of completing the post-operative pain assessment self-questionnaire.
* Patient having signed the informed consent of the French Ophthalmology Society for crosslinking.
* Patient affiliated to a social security system or beneficiary of such a system.

Exclusion Criteria:

* Woman without effective means of contraception, pregnant or breastfeeding.
* Patient who has already benefited from a crosslinking procedure on one of the eyes.
* Patient with a history of refractive surgery on one of the eyes.
* Patient with an intracorneal ring segment on one of the eyes.
* Patient suffering from a serious systemic pathology (autoimmune and/or immunodepressive)
* Patient with a psychiatric pathology.
* Patient on long-term analgesics and/or corticosteroids.
* Indication of crosslinking outside the classic protocol.
* Patient with central corneal opacity.
* Patient suffering from a severe dry eye syndrome or a neurotrophic keratitis.
* Patient with a history of ocular herpes.
* Patient with a history of ocular varicella-zoster virus infection.
* Patient with glaucoma.
* Patient treated with topical cyclosporine in the last 6 months.
* Patient deprived of liberty by a judicial or administrative decision.
* Patient subject to a legal protection measure or unable to express their consent.

Where this trial is running

Brest and 8 other locations

• CHU de Brest — Brest, France (Recruiting)
• Hospices Civils de Lyon — Lyon, France (Recruiting)
• Assistance Publique - Hôpitaux de Marseille — Marseille, France (Recruiting)
• CHU de Montpellier — Montpellier, France (Recruiting)
• CHU de Nantes — Nantes, France (Not_yet_recruiting)
• Hôpital National de la Vision des Quinze-Vingts — Paris, France (Recruiting)
• CHU de Saint-Etienne — Saint-Priest-en-Jarez, France (Recruiting)
• Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
• CHU de Toulouse — Toulouse, France (Recruiting)

Study contacts

• Study coordinator: Laurence BARNOUIN, MD

Conditions Progressive Keratoconus