Informations générales (source: ClinicalTrials.gov)
Multicenter, Randomized Study Evaluating the Use of a Non-sutured Sterile Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Interventional
Phase 3
TBF Genie Tissulaire (Voir sur ClinicalTrials)
novembre 2024
novembre 2025
12 avril 2025
Crosslinking is a therapeutic technique used to increase the rigidity of the cornea in
order to slow or stop progression of keratoconus. The main complication of the treatment
of keratoconus by crosslinking is postoperative pain due to the removal of the corneal
epithelium. Currently, the management of pain is done through the administration of
artificial tears and paracetamol. The amniotic membrane is a biological tissue used in
ophthalmology to treat injuries of the surface of the eye. It has healing and analgesic
properties.
The objective of this multicenter randomized study is to evaluate the benefit of placing
an amniotic membrane on the eye post-crosslinking to reduce pain and promote corneal
healing.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHNO DES QUINZE-VINGTS PARIS | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Assistance Publique - Hôpitaux de Marseille - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| CHU de Brest - 29609 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU de Montpellier - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
| CHU de Saint-Etienne - 42270 - Saint-Priest-en-Jarez - France | Contact (sur clinicalTrials) | ||||
| CHU de Toulouse - 31300 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Hôpitaux Universitaires de Strasbourg - 67000 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon - 69003 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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.