Study of Endothelial Keratoplasty Outcomes
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|ClinicalTrials.gov Identifier: NCT00800111|
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : January 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Fuchs' Endothelial Corneal Dystrophy Bullous Keratopathy Iridocorneal Endothelial Syndrome Posterior Polymorphous Dystrophy||Procedure: endothelial keratoplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2593 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||February 2018|
Endothelial keratoplasty procedure is performed.
Procedure: endothelial keratoplasty
Endothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea).
- Visual acuity [ Time Frame: 1, 3, 6, and 12 months and annually ]
- Endothelial cell density [ Time Frame: 6 months, 12 months and annually ]
- Intraocular pressure [ Time Frame: 1, 3, 6, 12 months and annually ]
- Manifest refraction [ Time Frame: 1, 3, 6, 12 months and annually ]
- corneal pachymetry [ Time Frame: 1, 3, 6, 12 months and annually ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800111
|United States, Indiana|
|Price Vision Group|
|Indianapolis, Indiana, United States, 46260|
|Principal Investigator:||Francis W Price, Jr., MD||Cornea Research Foundation of America|