Study of Endothelial Keratoplasty Outcomes

Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00800111

Enrollment

2593

Registered

2008-12-01

Start date

2008-02-29

Completion date

2018-02-28

Last updated

2019-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome, Posterior Polymorphous Dystrophy

Keywords

failed penetrating keratoplasty

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.

Interventions

PROCEDUREendothelial keratoplasty

Endothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Visual acuity	1, 3, 6, and 12 months and annually

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026