NCT00345020

Brief Summary

The research objectives of this study are to determine if small incision Deep Lamellar Endothelial Keratoplasty (DLEK) is able to further reduce the degree of corneal astigmatism and shorten the time course of corneal topography stabilization compared to standard full thickness corneal transplant (PKP) surgery.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

June 23, 2006

Last Update Submit

August 14, 2018

Conditions

Corneal Transplantation

Keywords

Deep Lamellar Endotheliam Keratoplasty

Outcome Measures

Primary Outcomes (1)

  • to determine if small incision Deep Lamellar Endothelial Keratoplasty (DLEK) is able to further reduce the degree of corneal astigmatism and shorten the time course of corneal topography stabilization

Interventions

Deep Lamellar Endothelial Keratoplasty: Small Incision TechniquePROCEDURE

Eligibility Criteria

Age21 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390-8866, United States

Location

Study Officials

  • Vinod Mootha, M.D.

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

US(1)