Safety Study of a Sutureless Amniotic Membran Transplantation to Treat Ocular Surface Disorders (Expanded Access)
NCT ID: NCT02168790
Last Updated: 2014-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
7 participants
INTERVENTIONAL
2011-02-28
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Amniotic membrane ring
Application of amniotic membrane device for 6-7 days.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Technische Universität Dresden
OTHER
Klinikum Chemnitz gGmbH
OTHER
Responsible Party
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Katrin Engelmann
Principal Investigator
Principal Investigators
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Ilya Kotomin
Role: STUDY_CHAIR
Klinikum Chemnitz gGmbH
Locations
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Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Countries
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References
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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
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.
Other Identifiers
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SKC002AR01
Identifier Type: -
Identifier Source: org_study_id
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