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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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)

Conditions
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Corneal Ulcers, Corneal Melting

Intervention / Treatment
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* Device: Amniotic membrane ring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amniotic membrane ring<br>Application of amniotic membrane device for 6-7 days. | Device: Amniotic membrane ring<br>* The amniotic membrane ring system (AmnioClip) is device for sutureless application of amniotic membrane to oculare surfaces. Amniotic membrane is mounted between the two rings with a specially designed, accessory mounting device.<br>* Other names: Amniotic membrane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit lamp investigation of the inflammation status of the conjunctiva | The ring of the AmnioClip touches the conjunctiva of the ocular surface. To prove side effects through the medical device the conjunctiva is controlled at every visit with microscopy using a slit lamp. | Participants will be followed for the duration of hospital stay, an expanded average of 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amniotic membrane holder, aminiotic membrane transplantation