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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02020044
Other study ID # EA2/108/12
Secondary ID
Status Recruiting
Phase N/A
First received December 11, 2013
Last updated December 18, 2013
Start date September 2012

Study information

Verified date December 2013
Source Charite University, Berlin, Germany
Contact Anna-Karina Maier, MD
Email anna-karina.maier@charite.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or female aged 18 or older

- Scheduled to undergo endothelial keratoplasty

- Able to provide written informed consent.

Exclusion Criteria:

- Age less than 18 years

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Endothelial Keratoplasty


Locations

Country Name City State
Germany Department of Ophthalmology, Charité - Universitätsmedizin Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Guerra FP, Anshu A, Price MO, Giebel AW, Price FW. Descemet's membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology. 2011 Dec;118(12):2368-73. doi: 10.1016/j.ophtha.2011.06.002. Epub 2011 Aug 27. — View Citation

Maier AK, Gundlach E, Gonnermann J, Klamann MK, Eulufi C, Bertelmann E, Joussen AM, Torun N. Fellow Eye Comparison of Descemet Membrane Endothelial Keratoplasty and Penetrating Keratoplasty. Cornea. 2013 Oct;32(10):1344-8. doi: 10.1097/ICO.0b013e31829dd816. — View Citation

Maier AK, Gundlach E, Klamann MK, Gonnermann J, Bertelmann E, Joussen AM, Torun N, Rieck PW. [Influence of donor lamella thickness on visual acuity after Descemet's stripping automated endothelial keratoplasty (DSAEK)]. Ophthalmologe. 2014 Feb;111(2):128-34. doi: 10.1007/s00347-013-2795-0. German. — View Citation

Maier AK, Klamann MK, Torun N, Gonnermann J, Schroeter J, Joussen AM, Rieck P. Intraocular pressure elevation and post-DSEK glaucoma after Descemet`s stripping endothelial keratoplasty. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1191-8. doi: 10.1007/s00417-012-2203-5. Epub 2012 Nov 20. — View Citation

van Dijk K, Ham L, Tse WH, Liarakos VS, Quilendrino R, Yeh RY, Melles GR. Near complete visual recovery and refractive stability in modern corneal transplantation: Descemet membrane endothelial keratoplasty (DMEK). Cont Lens Anterior Eye. 2013 Feb;36(1):13-21. doi: 10.1016/j.clae.2012.10.066. Epub 2012 Oct 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual acuity (change from baseline) 1, 3, 6, and 12 months and annually No
Secondary Endothelial cell density (change from baseline) 1, 3, 6, and 12 months and annually No
Secondary Intraocular pressure (change from baseline) 1, 3, 6, and 12 months and annually No
Secondary Manifest refraction (change from baseline) 1, 3, 6, 12 months and annually No
Secondary corneal pachymetry (change from baseline) 1, 3, 6, 12 months and annually No
Secondary Quality of Life, NEI-VFQ 25 (change from baseline) Questionnaire 3, 12 months, annualy No
Secondary corneal topography (change from baseline) 1, 3, 6, and 12 months and annually No
Secondary Anterior Segment OCT of cornea and anterior chamber angle (change from baseline) 1, 3, 6, and 12 months and annually No
Secondary postoperative Medication (change from baseline) 1,3,6 and 12 months and annually No
Secondary Histological Sample of Recipient's Descemet Membrane Recipient's Descemet Membrane intraoperative No
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