Using freeze-dried amniotic membrane after corneal crosslinking for keratoconus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Hôpital National de la Vision des Quinze-Vingts
  Paris, France Recruiting
• CHU de Saint-Etienne
  Saint-Priest-en-Jarez, France Recruiting

Study contacts

• Study coordinator: Laurence BARNOUIN, MD
• Email: laurence.barnouin@tbf-lab.com
• Phone: 0472686909

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.