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

TBF Genie Tissulaire

Status and phase

Enrolling

Phase 3

Conditions

Progressive Keratoconus

Treatments

Device: Therapeutic lens alone

Combination Product: Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06450470

GMALC

2024-A00004-43 (Registry Identifier)

Details and patient eligibility

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.

Enrollment

116 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Exclusion criteria

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.