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

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)

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02168790

Acronym

AmnioClip

Enrollment

Registered

2014-06-20

Start date

2011-02-28

Completion date

2013-08-31

Last updated

2014-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Melting, Corneal Ulcers

Keywords

amniotic membrane holder, aminiotic membrane transplantation

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).

Interventions

DEVICEAmniotic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

* An eye that, in the investigator's opinion, would not benefit from amniotic membrane transplantation

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026