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

Early Phase 1

Completed

• Conditions: Corneal Ulcers; Corneal Melting
• Interventions: Device: Amniotic membrane ring

• Registration Number: NCT02168790
• Lead Sponsor: Klinikum Chemnitz gGmbH

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).

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-08
• Study Completion: 2013-08
• Status Verified: 2014-06
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-18
• Last Update Submitted: 2014-06-18
• Study First Posted: 2014-06-20
• Last Update Posted: 2014-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amniotic membrane ring	Amniotic membrane ring	Application of amniotic membrane device for 6-7 days.

Primary Outcome Measures

Name	Time	Method
Slit lamp investigation of the inflammation status of the conjunctiva	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.

Trial Locations

Locations (1)

Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Saxony, Germany