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

Cornea Research Foundation of America

Status: Completed

Conditions: Corneal Edema; Fuchs Endothelial Dystrophy

Treatments: Procedure: Descemet's stripping endothelial keratoplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00624221

2005-10

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

1

Active Comparator group

Description:

An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.

Treatment:

Procedure: Descemet's stripping endothelial keratoplasty

2

Active Comparator group

Description:

The surgeon dissected the donor grafts used for the transplant procedures.

Treatment:

Procedure: Descemet's stripping endothelial keratoplasty