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

Not Applicable

• Conditions: Fuchs' Endothelial Corneal Dystrophy; Bullous Keratopathy; Iridocorneal Endothelial Syndrome; Posterior Polymorphous Dystrophy; Endothelial Dysfunction
• Interventions: Other: Endothelial Keratoplasty

• Registration Number: NCT02020044
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Status Verified: 2013-12
• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-18
• Last Update Submitted: 2013-12-18
• Study First Posted: 2013-12-24
• Last Update Posted: 2013-12-24
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endothelial Keratoplasty	Endothelial Keratoplasty	Descemet membrane endothelial keratoplasty DMEK Ultra-thin Descemet stripping automated endothelial keratoplasty Ultra-thin DSAEK

Primary Outcome Measures

Name	Time	Method
Visual acuity (change from baseline)	1, 3, 6, and 12 months and annually

Secondary Outcome Measures

Name	Time	Method
corneal topography (change from baseline)	1, 3, 6, and 12 months and annually
Endothelial cell density (change from baseline)	1, 3, 6, and 12 months and annually
Intraocular pressure (change from baseline)	1, 3, 6, and 12 months and annually
Manifest refraction (change from baseline)	1, 3, 6, 12 months and annually
corneal pachymetry (change from baseline)	1, 3, 6, 12 months and annually
Quality of Life, NEI-VFQ 25 (change from baseline)	3, 12 months, annualy	Questionnaire
Anterior Segment OCT of cornea and anterior chamber angle (change from baseline)	1, 3, 6, and 12 months and annually
postoperative Medication (change from baseline)	1,3,6 and 12 months and annually
Histological Sample of Recipient's Descemet Membrane	intraoperative	Recipient's Descemet Membrane

Trial Locations

Locations (1)

Department of Ophthalmology, Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany