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

Corneal Ulcers Clinical Trial

— AmnioClip  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168790
• Other study ID #: SKC002AR01
• Status: Completed
• Phase: Phase 0
• First received: June 12, 2014
• Last updated: June 18, 2014
• Start date: February 2011
• Est. completion date: August 2013

Study information

• Verified date: June 2014
• Source: Klinikum Chemnitz gGmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2013
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Melting
• Corneal Ulcer
• Corneal Ulcers

Intervention

Device:
• Amniotic membrane ring
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.

Locations

Country	Name	City	State
Germany	Klinikum Chemnitz gGmbH	Chemnitz	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Chemnitz gGmbH	Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (1)

1. Liu J, Sheha H, Fu Y et al. (2010) Update of amniotic membrane transplantation. Expert Review Ophthalmol 5:645-661 2. Dua HS, Azuara-Blanco A (1999) Amniotic membrane transplantation, Br J Ophthalmol 83:748-752 3. Daniel Meller, Mikk Pauklin, Henning Thomasen et al. (2011) Amniotic Membrane Transplantation in the Human Eye. Dtsch Arztebl Int 108: 243-8 4. Pachigolla G, Prasher P, Di Pasauale MA, Mc Culley JP, Mc Henry JG, Mootha VV, Evaluation of the role of ProKera in the mamagment of ocular surface and orbital disorders, Eye Contact Lens 2009, 35:172-175 5. Uhlig CE and Busse H, Development and evaluation of a device for sutureless and repeated application of amniotic memnbrane overlays. Cornea 29:331-5

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes