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

Phase 3

Terminated

• Conditions: Hypermetropia; Astigmatism; Myopia
• Interventions: Other: Therapeutic lens + amniotic membrane (Visio-AMTRIX); Other: Therapeutic lens alone

• Registration Number: NCT05247658
• Lead Sponsor: TBF Genie Tissulaire

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.

Study Timeline

• Study Start: 2022-01-25
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Primary Completion: 2022-07-21
• Study Completion: 2022-07-21
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic lens + amniotic membrane (Visio-AMTRIX)	Therapeutic lens + amniotic membrane (Visio-AMTRIX)	-
Therapeutic lens alone	Therapeutic lens alone	-

Primary Outcome Measures

Name	Time	Method
Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)	Day 1	Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Centre Monticelli-Paradis d'Ophtalmologie; 🇫🇷 Marseille, France

Clinique Vision Laser des Alpes; 🇫🇷 Grenoble, France

CHU de Saint-Etienne Hôpital Nord; 🇫🇷 Saint-Priest-en-Jarez, France