NCT03685734

Brief Summary

To assess objective and subjective visual outcomes achieved by patients with corneal endothelial dysfunction who have undergone surgical treatment with Descemet stripping automated endothelial keratoplasty (DSAEK).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 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

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2.7 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

September 26, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

September 25, 2018

Last Update Submit

September 25, 2018

Conditions

Corneal Endothelial Disorder

Keywords

DSAEK

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Scored with reference to the logarithm of the minimum angle of resolution (logMAR) and its variation in line gain.

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with corneal endothelial dysfunction underwent DSAEK

You may qualify if:

  • Clinical eligibility for DSAEK
  • Informed written consent
  • Successful completion of DSAEK procedure
  • Postoperative follow-up at least 1 year
  • Ability to respond to the questionnaire

You may not qualify if:

  • Patients with clinical edematous cornea
  • With significant stromal opacity
  • With major disturbances of ocular surface
  • Previous corneal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 26, 2018

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

January 1, 2016

Last Updated

September 26, 2018

Record last verified: 2018-08