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

Cornea Research Foundation of America40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fuchs Endothelial Dystrophy Corneal Edema

Interventions

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Endothelial Cell Loss

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.

Time frame: 6 months after grafting

Secondary Outcomes

Best Corrected Vision

Time frame: 6 months and 1 year after grafting

Graft Dislocation

Time frame: 1 day to 1 month after grafting