Study of Endothelial Keratoplasty Outcomes

Cornea Research Foundation of America

Status: Completed

Conditions: Iridocorneal Endothelial Syndrome; Bullous Keratopathy; Posterior Polymorphous Dystrophy; Fuchs' Endothelial Corneal Dystrophy

Treatments: Procedure: endothelial keratoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00800111

CRFA2008-01

Details and patient eligibility

About

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.

Enrollment: 2,593 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,593 participants in 1 patient group

Treatment

Other group

Description:

Endothelial keratoplasty procedure is performed.

Treatment:

Procedure: endothelial keratoplasty