Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fuchs' Endothelial Corneal Dystrophy
- Sponsor
- Cornea Research Foundation of America
- Enrollment
- 2593
- Locations
- 1
- Primary Endpoint
- Visual acuity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female aged 18 or older
- •Scheduled to undergo endothelial keratoplasty
- •Able to provide written informed consent.
Exclusion Criteria
- •Age less than 18 years
Outcomes
Primary Outcomes
Visual acuity
Time Frame: 1, 3, 6, and 12 months and annually
Secondary Outcomes
- Endothelial cell density(6 months, 12 months and annually)
- Intraocular pressure(1, 3, 6, 12 months and annually)
- Manifest refraction(1, 3, 6, 12 months and annually)
- corneal pachymetry(1, 3, 6, 12 months and annually)