MedTrace Logo

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

NCT05247658 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-12-07

No results posted yet for this study

Summary

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

Conditions

  • Myopia
  • Astigmatism
  • Hypermetropia

Interventions

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.

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.

Sponsors & Collaborators

  • TBF Genie Tissulaire

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2022-07-21
Completion
2022-07-21

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05247658 on ClinicalTrials.gov