Clinical Trial: Study of Endothelial Keratoplasty Outcomes
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes
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.
Detailed Summary:
Sponsor: Cornea Research Foundation of America
Current Primary Outcome: Visual acuity [ Time Frame: 1, 3, 6, and 12 months and annually ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Endothelial cell density [ Time Frame: 6 months, 12 months and annually ]
Information By: Cornea Research Foundation of America
Dates:
Date Received: November 26, 2008
Date Started: February 2008
Date Completion:
Last Updated: January 30, 2017
Last Verified: January 2017
