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Completed

NCT Number: NCT02168790

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

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.

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Key information

Conditions

Corneal Ulcers Corneal Diseases Corneal Melting Corneal Ulcer Eye Diseases Eye Infections Infections Keratitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, 09116, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amniotic membrane ring

Device

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.

Other names: Amniotic membrane

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Klinikum Chemnitz gGmbH

Other

Collaborators

  • Technische Universität Dresden

Registry information

Official study 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)

Acronym: AmnioClip

Important dates

Study start
2011
Primary completion
2011
Study completion
2013
First posted
Jun 20, 2014
Registry last updated
Jun 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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