CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,593 enrolled
Drug / intervention
endothelial keratoplastyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00800111
NCT00800111N/ACompleted

Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes

Cornea Research Foundation of America·interventional·Posted Dec 1, 2008·Updated Jan 23, 2019

In Brief

A clinical study evaluating endothelial keratoplasty for Fuchs' Endothelial Corneal Dystrophy and 3 related conditions. Completed, enrolled 2,593 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 1, 2008
Enrollment StartFeb 1, 2008
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 10 yearsPosted 17.6 years ago

Interventions

endothelial keratoplastyprocedure

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