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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTBF Genie Tissulaire

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Therapeutic lens alone
  • Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Treatment groups

116 Participants
are divided into 2 treatment groups

Sponsors and collaborators