Pratical Assessment of DSAEK in the Management of Endothelial Decompensation Following Penetrating Keratoplasty (MADE)

September 26, 2018 updated by: Centre Hospitalier Régional Metz-Thionville

Pratical Assessment of Descemet'Sstripping Automated Endothelial Keratoplasty (DSAEK) in the Management of Endothelial Decompensation Following Penetrating Keratoplasty

Reporting our anatomical and functional results and the possible complications of the first six Descemet's stripping endothelial keratoplasty (DSAEK) performed in our department secondary to endothelial decompensation after penetrating keratoplasty.

Study Overview

Status

Completed

Conditions

Detailed Description

A retrospective and observational monocentric study fo six patients with DSAEK after prior penetrating keratoplasty (PK). The data collected are: demographic characteristics, ophthalmological comorbidities, initial indication of PK, delay between PK and DSAEK. Preoperative Visual Acuity and at 1, 3 and 6 months postoperative were collected in logmar for analysis. The central cornea and graft thickness measured in OCT as well as the postoperative complications were also collected.

Study Type

Observational

Enrollment (Actual)

6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who profited of the first Descemet's stripping endothelial keratoplasty to endothelial decompensation after penetrating keratoplasty

Description

Inclusion Criteria:

  • with endothelial decompensation after penetrating keratoplasty
  • surgery realised by the same surgeon

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual acuity
Time Frame: change from visual acuity at 6 month
pre and postoperative visual acuity in logmar
change from visual acuity at 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cornea thickness
Time Frame: change from cornea thickness at 6 month
the central cornea and graft thickness measured in OCT
change from cornea thickness at 6 month
postoperative complications
Time Frame: month 6
all the postoperative complications were collected
month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

July 31, 2016

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-15Obs-CHRMT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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