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

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)

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.

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).

Inclusion Criteria:

• Patients with ocular surface disorders and indication for amniotic membrane transplantation
• Willingness to provide signed Informed Consent Form
• For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
• Ability and willingness to return for all scheduled visits and assessments

Exclusion Criteria:

• An eye that, in the investigator's opinion, would not benefit from amniotic membrane transplantation