NCT00874835

Brief Summary

The purpose of this study is to determine whether the surgical outcomes in patients undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of an insertion device over the traditional forceps insertion method.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

May 7, 2010

Status Verified

May 1, 2010

Enrollment Period

1.6 years

First QC Date

April 1, 2009

Last Update Submit

May 6, 2010

Conditions

Corneal Transplantation

Keywords

Endothelial KeratoplastyEKDescemet Stripping Endothelial KeratoplastyCorneal TransplantationKeratoplastyDSEKDSAEK

Outcome Measures

Primary Outcomes (1)

  • 6-month post-operative endothelial cell density

    6-months post-operatively

Secondary Outcomes (1)

  • 12-month post-operative endothelial cell density

    12-months post-operatively

Interventions

EndoSaver™ Corneal Endothelium Delivery InstrumentDEVICE

Efficacy of device to maintain function and integrity of corneal endothelial cells during insertion into the eye during keratoplasty.

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Fuchs endothelial dystrophy or bullous keratopathy determined to need a corneal transplant for visual restoration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Eye Center

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

  • Keith A Walter, MD

    Wake Forest University Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 3, 2009

Study Start

March 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

May 7, 2010

Record last verified: 2010-05

Locations

US(1)