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| Sponsor: | Cornea Research Foundation of America |
|---|---|
| Information provided by: | Cornea Research Foundation of America |
| ClinicalTrials.gov Identifier: | NCT00800111 |
Purpose
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 | Intervention |
|---|---|
|
Fuchs' Endothelial Corneal Dystrophy Bullous Keratopathy Iridocorneal Endothelial Syndrome Posterior Polymorphous Dystrophy |
Procedure: endothelial keratoplasty |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment |
| Official Title: | Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes |
| Estimated Enrollment: | 4000 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment
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).
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Francis W Price, Jr., MD | 317-814-2990 | fprice@pricevisiongroup.net |
| United States, Indiana | |
| Price Vision Group | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Francis W Price, Jr., MD | |
| Principal Investigator: Francis W Price, Jr., MD | |
| United States, Washington | |
| Pacific Cataract & Laser Institute | Recruiting |
| Chehalis, Washington, United States, 98532 | |
| Contact: Arthur W Giebel, MD 360-748-8632 Arthur.Giebel@pcli.com | |
| Principal Investigator: Arthur W Giebel, MD | |
| Principal Investigator: | Francis W Price, Jr., MD | Cornea Research Foundation of America |
More Information
| Responsible Party: | Cornea Research Foundation of America ( Francis W. Price, Jr. MD ) |
| Study ID Numbers: | CRFA2008-01 |
| Study First Received: | November 26, 2008 |
| Last Updated: | February 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00800111 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
failed penetrating keratoplasty |
|
Corneal Diseases Pathologic Processes Disease Genetic Diseases, Inborn Corneal Dystrophies, Hereditary |
Eye Diseases Syndrome Fuchs' Endothelial Dystrophy Corneal Edema Eye Diseases, Hereditary |
