Status:
TERMINATED
Use of a Disk of Amniotic Membrane (Visio-AMTRIX) in Postoperative Care After PKR
Lead Sponsor:
TBF Genie Tissulaire
Conditions:
Myopia
Astigmatism
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this open controlled multicenter trial is to assess the impact of use of an amniotic membrane on post PKR recovery.
Detailed Description
Photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK) are two of the most widely used techniques of laser vision correction. However, one of the major disadvantages of th...
Eligibility Criteria
Inclusion
- Male or female, aged 18 to 80 years.
- Patient undergoing bilateral PRK procedure for myopia, astigmatism or hypermetropia with technique chosen for one of the following reasons: thin cornea, irregular cornea, suspected keratoconus, practice of combat or contact sports, professional activity at risk of direct impact.
- Patient understanding french language.
- Patient who received the study information and provided written consent to participation in the study.
- Patient who is a member or a beneficiary of a national health insurance plan.
Exclusion
- Pregnant woman.
- Patient with a contraindication to PRK.
- Diabetic patient.
- Patient allergic to Oxybuprocaine and / or Tetracaine eye drops, to local anesthetics or to fluorescein.
- Monophthalmic patient.
- Person deprived of liberty by a judicial or administrative decision.
- Adult subjected to a legal protection measure or unable to express his / her consent.
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05247658
Start Date
January 25 2022
End Date
July 21 2022
Last Update
December 7 2022
Active Locations (3)
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1
Clinique Vision Laser des Alpes
Grenoble, France, 38000
2
Centre Monticelli-Paradis d'Ophtalmologie
Marseille, France, 13006
3
CHU de Saint-Etienne Hôpital Nord
Saint-Priest-en-Jarez, France, 42270