Actively Recruiting
Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Led by TBF Genie Tissulaire · Updated on 2025-04-11
116
Participants Needed
9
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Man or woman between 18 and 65 years old.
- Indication for accelerated conventional crosslinking.
- Patient with progressive keratoconus (increase in Kmax of 65 0.5 diopters in 3 to 6 months or 65 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 65 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.
You will not qualify if you...
- 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.
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Trial Site Locations
Total: 9 locations
1
CHU de Brest
Brest, France, 29609
Actively Recruiting
2
Hospices Civils de Lyon
Lyon, France, 69003
Actively Recruiting
3
Assistance Publique - Hôpitaux de Marseille
Marseille, France, 13005
Actively Recruiting
4
CHU de Montpellier
Montpellier, France, 34295
Actively Recruiting
5
CHU de Nantes
Nantes, France, 44000
Not Yet Recruiting
6
Hôpital National de la Vision des Quinze-Vingts
Paris, France, 75012
Actively Recruiting
7
CHU de Saint-Etienne
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
8
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
9
CHU de Toulouse
Toulouse, France, 31300
Actively Recruiting
Research Team
L
Laurence BARNOUIN, MD
CONTACT
J
Justine BOSC, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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