Clinical trial NCT05247658: Use of a Disk of Amniotic Membrane (Visio-AMTRIX) in Postoperative Care After PKR
Official title: Study Comparing a Therapeutic Lens Used Alone to a Therapeutic Lens Used in Association With an Amniotic Membrane Treated by the AMTRIX Process in Postoperative Care After Photorefractive Keratectomy (PRK)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Myopia
Astigmatism
Hypermetropia
Keywords: PhotoRefractive Keratectomy (PRK)
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Self-controlled trial: each patient serves as his or her own control. After bilateral PRK procedure, patients will receive both treatments, one treatment in each eye.
Primary purpose: SUPPORTIVE_CARE

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 the PRK technique is the pain experienced during 1 to 3 days after intervention.

Preliminary data on a limited number of patients tend to show a reduction of pain, tearing and discomfort in patients for whom a amniotic membrane was used under a therapeutic lens.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
timeFrame: Day 1
Secondary outcomes:
measure: Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
timeFrame: 2 days, 3 days, 30 to 45 days
measure: Change of visual discomfort in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
timeFrame: 1 day, 2 days, 3 days, 30 to 45 days
measure: Identical healing of both eyes
timeFrame: 2 or 3 days, 30 to 45 days
measure: Better visual acuity in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
timeFrame: 30 to 45 days
measure: Rate of corneal haze for each treatment
timeFrame: 30 to 45 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinique Vision Laser des Alpes
city: Marseille
country: France
facility: Centre Monticelli-Paradis d'Ophtalmologie
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne Hôpital Nord
Study officials:
References: