Safety Study of a Sutureless Amniotic Membran Transplantation to Treat Ocular Surface Disorders (Expanded Access) (AmnioClip)
Primary Purpose
Corneal Ulcers, Corneal Melting
Status
Completed
Phase
Early Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Amniotic membrane ring
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Ulcers focused on measuring amniotic membrane holder, aminiotic membrane transplantation
Eligibility 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
Sites / Locations
- Klinikum Chemnitz gGmbH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Amniotic membrane ring
Arm Description
Application of amniotic membrane device for 6-7 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02168790
First Posted
June 12, 2014
Last Updated
June 18, 2014
Sponsor
Klinikum Chemnitz gGmbH
Collaborators
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT02168790
Brief Title
Safety Study of a Sutureless Amniotic Membran Transplantation to Treat Ocular Surface Disorders (Expanded Access)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinikum Chemnitz gGmbH
Collaborators
Technische Universität Dresden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Ulcers, Corneal Melting
Keywords
amniotic membrane holder, aminiotic membrane transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amniotic membrane ring
Arm Type
Experimental
Arm Description
Application of amniotic membrane device for 6-7 days.
Intervention Type
Device
Intervention Name(s)
Amniotic membrane ring
Other Intervention Name(s)
Amniotic membrane
Intervention Description
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.
Primary Outcome Measure Information:
Title
Slit lamp investigation of the inflammation status of the conjunctiva
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expanded average of 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilya Kotomin
Organizational Affiliation
Klinikum Chemnitz gGmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
State/Province
Saxony
ZIP/Postal Code
09116
Country
Germany
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
background
PubMed Identifier
25955359
Citation
Kotomin I, Valtink M, Hofmann K, Frenzel A, Morawietz H, Werner C, Funk RH, Engelmann K. Sutureless fixation of amniotic membrane for therapy of ocular surface disorders. PLoS One. 2015 May 8;10(5):e0125035. doi: 10.1371/journal.pone.0125035. eCollection 2015.
Results Reference
derived
Learn more about this trial
Safety Study of a Sutureless Amniotic Membran Transplantation to Treat Ocular Surface Disorders (Expanded Access)
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