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

PHASE3RecruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

November 25, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Progressive Keratoconus
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.

Trial Locations (9)

13005

RECRUITING

Assistance Publique - Hôpitaux de Marseille, Marseille

29609

RECRUITING

CHU de Brest, Brest

31300

RECRUITING

CHU de Toulouse, Toulouse

34295

RECRUITING

CHU de Montpellier, Montpellier

42270

RECRUITING

CHU de Saint-Etienne, Saint-Priest-en-Jarez

44000

NOT_YET_RECRUITING

CHU de Nantes, Nantes

67000

RECRUITING

Hôpitaux Universitaires de Strasbourg, Strasbourg

69003

RECRUITING

Hospices Civils de Lyon, Lyon

75012

RECRUITING

Hôpital National de la Vision des Quinze-Vingts, Paris

Sponsors
All Listed Sponsors
lead

TBF Genie Tissulaire

INDUSTRY