DMEK And Cataract Surgery: Comparison Of Sequential Versus Combined Procedure (CISIPHE)

August 23, 2023 updated by: Centre Hospitalier Régional Metz-Thionville
The aim of this study is to describe the outcomes of phaco-DMEK (Descemet Membrane Endothelial Keratoplasty ) according to a sequential versus a combined procedure

Study Overview

Status

Completed

Conditions

Detailed Description

The study included patients who underwent DMEK combined or not with cataract surgery between January 2014 and march 2016. Were excluded patients with other ocular comorbidity, and those who had graft after a first graft failure. The main outcome was BVCA measured at one year. The post-operative follow up was down at D7, M1, M3, M6, and M12. Secondary outcomes were; the mean time to visual recovery and influence of the delay between cataract removal and DMEK.

Study Type

Observational

Enrollment (Actual)

31

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients who underwent DMEK combined or not with cataract surgery

Description

Inclusion Criteria:

  • patients who underwent DMEK combined or not with cataract surgery

Exclusion Criteria:

  • patients with other ocular comorbidity, and those who had graft after a first graft failure

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best visual acuity
Time Frame: Month 12
logMar
Month 12

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)

November 1, 2016

Primary Completion (Actual)

May 30, 2017

Study Completion (Actual)

May 30, 2017

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria

November 23, 2017

First Posted (Actual)

November 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-08Obs-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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