Safety Study of a Sutureless Amniotic Membran Transplantation to Treat Ocular Surface Disorders (Expanded Access) (AmnioClip)
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|ClinicalTrials.gov Identifier: NCT02168790|
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : June 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Corneal Ulcers Corneal Melting||Device: Amniotic membrane ring||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|Klinikum Chemnitz gGmbH|
|Chemnitz, Saxony, Germany, 09116|
|Study Chair:||Ilya Kotomin||Klinikum Chemnitz gGmbH|