NCT05247658

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: TBF Genie Tissulaire · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia
• Astigmatism
• Hypermetropia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-25
• Primary completion: 2022-07-21
• Completion: 2022-07-21
• First posted: 2022-02-21
• Last updated: 2022-12-07

Locations

3 sites across 1 country: France