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Study of Endothelial Keratoplasty Outcomes

NCT00800111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2593

Last updated 2019-01-23

No results posted yet for this study

Summary

Endothelial keratoplasty is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. This technique offers many advantages compared with traditional full-thickness cornea transplants. Patients experience minimal change in glasses prescription and usually recover useful vision within weeks. Visual fluctuations are minimal during the healing process. The patient's cornea remains structurally intact and is more resistant to injury.

Endothelial keratoplasty is undergoing rapid and widespread adoption. Between 2005 and 2007, the number of corneas placed by US eye banks for endothelial keratoplasty increased ten-fold (2007 Eye Bank Association of America Annual Report). However, the procedure is less than 10 years old, and little is known about long term outcomes. Endothelial keratoplasty candidates at our center are invited to participate in an open enrollment, prospective study of the long-term outcomes of this procedure.

Conditions

  • Fuchs' Endothelial Corneal Dystrophy
  • Bullous Keratopathy
  • Iridocorneal Endothelial Syndrome
  • Posterior Polymorphous Dystrophy

Interventions

PROCEDURE

endothelial keratoplasty

Endothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea).

Sponsors & Collaborators

  • Cornea Research Foundation of America

    lead OTHER

Principal Investigators

  • Francis W Price, Jr., MD · Cornea Research Foundation of America

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800111 on ClinicalTrials.gov