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

Myopia Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05247658
• Other study ID #: AMTRIX-PKR-TBF
• Secondary ID: 2021-A01933-38
• Status: Terminated
• Phase: Phase 3
• Start date: January 25, 2022
• Est. completion date: July 21, 2022

Study information

• Verified date: December 2022
• Source: TBF Genie Tissulaire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 21, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Hypermetropia
• Hyperopia
• Myopia

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Clinique Vision Laser des Alpes	Grenoble
France	Centre Monticelli-Paradis d'Ophtalmologie	Marseille
France	CHU de Saint-Etienne Hôpital Nord	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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