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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168790
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : June 20, 2014
Sponsor:
Collaborator:
Technische Universität Dresden
Information provided by (Responsible Party):
Katrin Engelmann, 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.

Condition or disease Intervention/treatment Phase
Corneal Ulcers Corneal Melting Device: Amniotic membrane ring Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : February 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: Amniotic membrane ring
Application of amniotic membrane device for 6-7 days.
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.
Other Name: Amniotic membrane




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168790


Locations
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Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany, 09116
Sponsors and Collaborators
Klinikum Chemnitz gGmbH
Technische Universität Dresden
Investigators
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Study Chair: Ilya Kotomin Klinikum Chemnitz gGmbH
Publications:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Katrin Engelmann, Principal Investigator, Klinikum Chemnitz gGmbH
ClinicalTrials.gov Identifier: NCT02168790    
Other Study ID Numbers: SKC002AR01
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014
Keywords provided by Katrin Engelmann, Klinikum Chemnitz gGmbH:
amniotic membrane holder, aminiotic membrane transplantation
Additional relevant MeSH terms:
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Corneal Ulcer
Eye Infections
Infection
Keratitis
Corneal Diseases
Eye Diseases