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

Corneal Edema Clinical Trial

Official title:

A Prospective, Randomized, Single Center Study Evaluating Use of Surgeon- and Eye Bank-prepared Donor Tissue for Descemet's Stripping and Endothelial Keratoplasty, a Type of Cornea Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624221
• Other study ID #: 2005-10
• Status: Completed
• Phase: N/A
• First received: February 19, 2008
• Last updated: October 21, 2010
• Start date: January 2006
• Est. completion date: November 2007

Study information

• Verified date: October 2010
• Source: Cornea Research Foundation of America
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Edema
• Fuchs Endothelial Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Procedure:
• Descemet's stripping endothelial keratoplasty
Small incision corneal transplant procedure to treat dysfunctional endothelium.

Locations

Country	Name	City	State
United States	Cornea Research Foundation of America	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Cornea Research Foundation of America	North Carolina Lion's Eye Bank, Price Vision Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after grafting	No
Secondary	Best Corrected Vision		6 months and 1 year after grafting	Yes
Secondary	Graft Dislocation		1 day to 1 month after grafting	No