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Completed

NCT Number: NCT00624221

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

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.

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Key information

Conditions

Fuchs Endothelial Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal Edema Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cornea Research Foundation of America

Indianapolis, Indiana, 46260, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Descemet's stripping endothelial keratoplasty

Procedure

Small incision corneal transplant procedure to treat dysfunctional endothelium.

Primary outcomes

  1. Endothelial Cell Loss

    Time frame: 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 outcomes

  1. Best Corrected Vision

    Time frame: 6 months and 1 year after grafting

  2. Graft Dislocation

    Time frame: 1 day to 1 month after grafting

Sponsors and collaborators

Lead sponsor

Cornea Research Foundation of America

Other

Collaborators

  • North Carolina Lion's Eye Bank
  • Price Vision Group

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 27, 2008
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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