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

NCT00624221 | Completed Results

• 1 other identifier: 2005-10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fuchs Endothelial Dystrophy; Corneal Edema

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Best Corrected Vision

  6 months and 1 year after grafting

• Graft Dislocation

  1 day to 1 month after grafting

Study Arms (2)

1

ACTIVE COMPARATOR

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

Procedure: Descemet's stripping endothelial keratoplasty

2

ACTIVE COMPARATOR

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

Procedure: Descemet's stripping endothelial keratoplasty

Interventions

Descemet's stripping endothelial keratoplasty PROCEDURE

Small incision corneal transplant procedure to treat dysfunctional endothelium.

1; 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cornea Research Foundation of America: lead
• North Carolina Lion's Eye Bank: collaborator
• Price Vision Group: collaborator

Study Sites (1)

Cornea Research Foundation of America

Indianapolis, Indiana, 46260, United States

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Corneal Edema

Interventions

Descemet Stripping Endothelial Keratoplasty

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Corneal Transplantation; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Transplantation

Results Point of Contact

• Title: Marianne O. Price, PhD
• Organization: Cornea Research Foundation of America

mprice@cornea.org

317-814-2990

Study Officials

• Francis W Price, Jr, MD

  Cornea Research Foundation of America

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 27, 2008
• Study Start: January 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 27, 2016
• Results First Posted: March 12, 2010

Record last verified: 2010-10

Locations

US (1)