Safety Study of a Sutureless Amniotic Membran Transplantation to Treat Ocular Surface Disorders (Expanded Access) — AmnioClip  

Corneal Ulcers Clinical Trial

Official title: Interventional Study to Investigate the Safety of a Combination of Amniotic Membrane and a Holder Device (AmnioClip) in the Therapy of Ocular Surface Disorders (Sutureless Amniotic Membrane Transplantation)

Status Completed

Clinical Trial Summary

The investigators aimed at developing a technique to apply amniotic membrane to a diseased ocular surface without surgical intervention (sutureless amniotic membrane transplantation). This system needs to be concordant with laws and guidelines for the use of medical and pharmaceutical products.

Clinical Trial Description

A ring system (AmnioClip) was developed for mounting an amniotic membrane (AM) that can be applied like a large contact lens. AM is mounted between the two rings with a special designed, accessory mounting device. The safety of the ring system AmnioClip was tested in an interventional including 7 patients with ocular surface disorders and need for AM transplantation (1, 2, 3). About similar systems was reported (3, 4). ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Melting
• Corneal Ulcer
• Corneal Ulcers

• NCT number: NCT02168790
• Study type: Interventional
• Source: Klinikum Chemnitz gGmbH
• Status: Completed
• Phase: Phase 0
• Start date: February 2011
• Completion date: August 2013