Use of a Disk of Amniotic Membrane (Visio-AMTRIX) in Postoperative Care After PKR

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)

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

Study Overview

• Status: Terminated
• Conditions: Astigmatism; Myopia; Hypermetropia
• Intervention / Treatment: Other: Therapeutic lens alone; Other: Therapeutic lens + amniotic membrane (Visio-AMTRIX)

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38000
    • Clinique Vision Laser des Alpes
  • Marseille, France, 13006
    • Centre Monticelli-Paradis d'Ophtalmologie
  • Saint-Priest-en-Jarez, France, 42270
    • CHU de Saint-Etienne Hôpital Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Therapeutic lens alone	Other: Therapeutic lens alone; Therapeutic lens will be apposed on patient's dominant eye after bilateral PRK. Therapeutic lens will be maintained without interruption until the first postoperative visit when it will be removed by the surgeon.
Experimental: Therapeutic lens + amniotic membrane (Visio-AMTRIX)	Other: Therapeutic lens + amniotic membrane (Visio-AMTRIX); Amniotic membrane (Visio-AMTRIX) will be apposed under therapeutic lens on patient's non-dominant eye after bilateral PRK. Amniotic membrane and therapeutic lens will be maintained without interruption until the first postoperative visit when it will be removed by the surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change 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	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change 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	2 days, 3 days, 30 to 45 days
Change of visual discomfort in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)	Evaluation by the patient of visual discomfort criteria; tearing, foreign body sensation, blurred vision, and photophobia; from 0: no discomfort to 10: worst imaginable discomfort on visual analog scale (VAS) in both eyes	1 day, 2 days, 3 days, 30 to 45 days
Identical healing of both eyes	Healing evaluated under slit lamp by fluorescein examination with measurement of ulcer size	2 or 3 days, 30 to 45 days
Better visual acuity in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)	Determination of logMAR values of uncorrected visual acuity and best corrected visual acuity for both eyes	30 to 45 days
Rate of corneal haze for each treatment	Evaluation of presence of corneal haze through the Hanna's grading scale from grade 0: no haze to grade 4: very severe haze	30 to 45 days

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): July 21, 2022

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: PhotoRefractive Keratectomy (PRK)
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Hyperopia
• Other Study ID Numbers: AMTRIX-PKR-TBF; 2021-A01933-38 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No