NCT03685851

Brief Summary

To study the correlation between graft size in DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) and UT (ultra thin)-DSAEK type corneal transplants to the visual acuity 6 months postoperatively.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Status
completed

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

February 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
Last Updated

October 11, 2018

Status Verified

September 1, 2018

Enrollment Period

3.2 years

First QC Date

September 25, 2018

Last Update Submit

October 9, 2018

Conditions

Corneal Transplant

Outcome Measures

Primary Outcomes (1)

  • Postoperative visual acuity

    postoperative visual acuity in logmar

    Month 6

Secondary Outcomes (1)

  • Pachymetry

    Month 6

Study Arms (2)

UT-DSAEK

With graft 6 months thick less than 100 µm

Procedure: DSAEK type corneal transplant

DSAEK

With graft thicker than 100 µm

Procedure: DSAEK type corneal transplant

Interventions

DSAEK type corneal transplantPROCEDURE

All surgeries were performed by the same surgeon and according to the same protocol

DSAEKUT-DSAEK

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent DSAEK surgery between february 2012 and june 2017

You may qualify if:

  • Patients who underwent DSAEK surgery
  • Patients in department of ophthalmology between february 2012 and june 2017

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 26, 2018

Study Start

February 1, 2012

Primary Completion

April 1, 2015

Study Completion

June 30, 2017

Last Updated

October 11, 2018

Record last verified: 2018-09