Study of Endothelial Keratoplasty Outcomes

Not Applicable

Completed

• Conditions: Fuchs' Endothelial Corneal Dystrophy; Bullous Keratopathy; Posterior Polymorphous Dystrophy; Iridocorneal Endothelial Syndrome
• Interventions: Procedure: endothelial keratoplasty

• Registration Number: NCT00800111
• Lead Sponsor: Cornea Research Foundation of America

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 Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-28
• Study First Posted: 2008-12-01
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2593

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	endothelial keratoplasty	Endothelial keratoplasty procedure is performed.

Primary Outcome Measures

Name	Time	Method
Visual acuity	1, 3, 6, and 12 months and annually

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States