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

Recruiting Phase 3 Interventional Study
Progressive Keratoconus
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
116 (estimated)
Sponsor
TBF Genie Tissulaire · Industry
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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 membra…
Trial Locations
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Eligibility Criteria
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 …
Contacts

Laurence BARNOUIN, MD

0472686909

laurence.barnouin@tbf-lab.com

CONTACT

Justine BOSC, MSc

4 72 68 69 11

justine.bosc@tbf-lab.com

CONTACT