Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Endothelial Dysfunction Clinical Trial

Official title:

Prospective Clinical Study on Postoperative Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02020044
• Other study ID #: EA2/108/12
• 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. 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

• Bullous Keratopathy
• Endothelial Dysfunction
• Fuchs' Endothelial Corneal Dystrophy
• Fuchs' Endothelial Dystrophy
• Iridocorneal Endothelial Syndrome
• Posterior Polymorphous Dystrophy

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