The Effect Of Preoperative Parameters On Success After DMEK Surgery

July 18, 2022 updated by: Semih Çakmak, Beyoglu Eye Research and Education Hospital

The Effect Of Preoperative Anterior Segment Parameters On Success After Descemet Membrane Endothelial Keratoplasty (Dmek) Surgery

The aim of this study is to evaluate the effect of preoperative parameters on surgical results in Descemet Membrane Endothelial Keratoplasty (DMEK) surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In patients undergoing Descemet Membrane Endothelial Keratoplasty (DMEK) surgery; preoperative anterior chamber depth, angle parameters, axial length and corneal parameters will be evaluated. The effects of these parameters on surgical results will be examined.

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34420
        • Beyoglu Eye Training and Research Hospital

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

Probability Sample

Study Population

Patients who developed pseudophakic bullous keratopathy, Fuchs endothelial dystrophy, endothelial insufficiency after herpetic endotheliitis and associated permanent corneal edema and therefore DMEK surgery.

Description

Inclusion Criteria:

  • Scheduled to undergo Descemet membrane endothelial keratoplasty(DMEK)
  • aged 18 old older

Exclusion Criteria:

  • Patients with corneal pathology other than endothelial insufficiency
  • Glaucoma patients,
  • Patients who have previously had any keratoplasty procedure

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
All patients
Procedure: Descemet membrane endothelial keratoplasty (DMEK)
All participants underwent DMEK surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual acuity
Time Frame: Baseline and after surgery 1, 3, 6, and 12 months
Change from baseline
Baseline and after surgery 1, 3, 6, and 12 months
Change in endothelial cell density
Time Frame: after surgery 1, 3, 6, and 12 months
Change from baseline
after surgery 1, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maximum (steepest) and minimum (flattest) keratometry values in the central corneal zone
Time Frame: Baseline and after surgery 1, 3, 6, and 12 months
Change from baseline
Baseline and after surgery 1, 3, 6, and 12 months
Change in anterior chamber depth
Time Frame: Baseline and after surgery 1, 3, 6, and 12 months
Change from baseline
Baseline and after surgery 1, 3, 6, and 12 months
Change in axial length
Time Frame: Baseline and after surgery 1, 3, 6, and 12 months
Change from baseline
Baseline and after surgery 1, 3, 6, and 12 months
Change in central pachymetry
Time Frame: Baseline and after surgery 1, 3, 6, and 12 months
Change from baseline
Baseline and after surgery 1, 3, 6, and 12 months
Change in intraocular pressure
Time Frame: Baseline and after surgery 1, 3, 6, and 12 months
Change from baseline
Baseline and after surgery 1, 3, 6, and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical complications
Time Frame: During surgery
Complications occurring during the surgery will be recorded.
During surgery

Collaborators and Investigators

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

Sponsor

Beyoglu Eye Research and Education Hospital

Investigators

  • Principal Investigator: Semih Çakmak, MD, Beyoglu Eye Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

July 10, 2022

Study Registration Dates

First Submitted

May 16, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeyogluEREH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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