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RECRUITING
NCT06450470
PHASE3

Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus

Sponsor: TBF Genie Tissulaire

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

COMBINATION_PRODUCT

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