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

Klinikum Chemnitz gGmbH

Status and phase

Completed

Early Phase 1

Conditions

Corneal Melting

Corneal Ulcers

Treatments

Device: Amniotic membrane ring

Study type

Interventional

Funder types

Other

Identifiers

NCT02168790

SKC002AR01

Details and patient eligibility

About

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.

Full 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).

Enrollment

7 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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