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Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Sponsor: TBF Genie Tissulaire
Summary
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.
Official title: Multicenter, Randomized Study Evaluating the Use of a Non-sutured Sterile Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2024-11-25
Completion Date
2025-11
Last Updated
2025-04-11
Healthy Volunteers
No
Conditions
Interventions
Therapeutic lens alone
Therapeutic lens will be apposed on the patient's eye after crosslinking. Therapeutic lens will be maintained without interruption until the first postoperative visit (Day 2) when it will be removed by the investigator.
Therapeutic lens + amniotic membrane (Visio-AMTRIX)
Amniotic membrane (Visio-AMTRIX) will be apposed under therapeutic lens on the patient's eye after crosslinking. Amniotic membrane and therapeutic lens will be maintained without interruption until the first postoperative visit (Day 2) when it will be removed by the investigator.
Locations (9)
CHU de Brest
Brest, France
Hospices Civils de Lyon
Lyon, France
Assistance Publique - Hôpitaux de Marseille
Marseille, France
CHU de Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
Hôpital National de la Vision des Quinze-Vingts
Paris, France
CHU de Saint-Etienne
Saint-Priest-en-Jarez, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
CHU de Toulouse
Toulouse, France