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)
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Corneal Ulcers
- Sponsor
- Klinikum Chemnitz gGmbH
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Slit lamp investigation of the inflammation status of the conjunctiva
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed 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).
Investigators
Katrin Engelmann
Principal Investigator
Klinikum Chemnitz gGmbH
Eligibility Criteria
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
Outcomes
Primary Outcomes
Slit lamp investigation of the inflammation status of the conjunctiva
Time Frame: Participants will be followed for the duration of hospital stay, an expanded average of 3 month
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.