Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty

NCT ID: NCT00624221

Last Updated: 2016-04-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-11-30

Brief Summary

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Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.

Detailed Description

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Conditions

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Fuchs Endothelial Dystrophy Corneal Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.

Group Type ACTIVE_COMPARATOR

Descemet's stripping endothelial keratoplasty

Intervention Type PROCEDURE

Small incision corneal transplant procedure to treat dysfunctional endothelium.

2

The surgeon dissected the donor grafts used for the transplant procedures.

Group Type ACTIVE_COMPARATOR

Descemet's stripping endothelial keratoplasty

Intervention Type PROCEDURE

Small incision corneal transplant procedure to treat dysfunctional endothelium.

Interventions

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Descemet's stripping endothelial keratoplasty

Small incision corneal transplant procedure to treat dysfunctional endothelium.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* candidate for Descemet's stripping with endothelial keratoplasty
* at least 21 years old
* willing and able to return for scheduled follow-up visits
* reads and signs Informed Consent document

Exclusion Criteria

* visual acuity of less than 20/400 in fellow eye
* known sensitivity to planned study concomitant medications
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Carolina Lion's Eye Bank

UNKNOWN

Sponsor Role collaborator

Price Vision Group

INDUSTRY

Sponsor Role collaborator

Cornea Research Foundation of America

OTHER

Sponsor Role lead

Responsible Party

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Cornea Research Foundation of America

Principal Investigators

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Francis W Price, Jr, MD

Role: PRINCIPAL_INVESTIGATOR

Cornea Research Foundation of America

Locations

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Cornea Research Foundation of America

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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2005-10

Identifier Type: -

Identifier Source: org_study_id

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