The study of a disk of amniotic membrane (Visio-AMTRIX) in postoperative care after PKR

The research company TBF Genie Tissulaire is conducting the clinical trial.

The purpose of this open controlled multicenter trial is to assess the impact of use of an amniotic membrane on post PKR recovery.

It is planned to include 40 participants.

Actual study start date is January 25, 2022. The researchers expect to complete the study by September 2022.

One primary outcome measure is Decrease of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator), Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes.

The location of the study is as follows (further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05247658.

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