Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty

Not Applicable

Completed

• Conditions: Corneal Edema; Fuchs Endothelial Dystrophy
• Interventions: Procedure: Descemet's stripping endothelial keratoplasty

• Registration Number: NCT00624221
• Lead Sponsor: Cornea Research Foundation of America

Brief Summary

Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-10
• Study Completion: 2007-11
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-27
• Results First Submitted: 2010-02-02
• Results First Submitted QC: 2010-03-02
• Results First Posted: 2010-03-12
• Status Verified: 2010-10
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• candidate for Descemet's stripping with endothelial keratoplasty
• at least 21 years old
• willing and able to return for scheduled follow-up visits
• reads and signs Informed Consent document

Exclusion Criteria

• visual acuity of less than 20/400 in fellow eye
• known sensitivity to planned study concomitant medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Descemet's stripping endothelial keratoplasty	The surgeon dissected the donor grafts used for the transplant procedures.
1	Descemet's stripping endothelial keratoplasty	An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.

Primary Outcome Measures

Name	Time	Method
Endothelial Cell Loss	6 months after grafting	Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.

Secondary Outcome Measures

Name	Time	Method
Best Corrected Vision	6 months and 1 year after grafting
Graft Dislocation	1 day to 1 month after grafting

Trial Locations

Locations (1)

Cornea Research Foundation of America; 🇺🇸 Indianapolis, Indiana, United States