Descemet Membrane Endothelial Keratoplasty vs. Descemet's Stripping With Endothelial Keratoplasty vs. Descemet Stripping Only

January 11, 2023 updated by: Wake Forest University Health Sciences

Incidence of Post-operative Cystoid Macular Edema: A Prospective Study Comparing DMEK, DSEK, and DSO

This study aims to evaluate and compare incidence of post-operative cystoid macular edema (CME) after Descemet Membrane Endothelial Keratoplasty (DMEK), Descemet's Stripping Automated endothelial Keratoplasty (DSEK) and Descemet Stripping Only (DSO).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients that are undergoing any of these procedures will be asked if they are willing to have a baseline pre-operative Optical Coherence Tomography (OCT) scan completed within 4 weeks of surgery. Additional OCT scans will be collected during routine follow up care. It is hypothesized that the rates of CME will be lower with DSO compared to DMEK and DSEK.

Study Type

Observational

Enrollment (Actual)

4

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

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences

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 with endothelial dysfunction that require treatment, and are being evaluated for Descemet Stripping Only (DSO), Descemet Membrane Endothelial Keratoplasty (DMEK) or Descemet's Stripping Automated Endothelial Keratoplasty (DSEK)

Description

Inclusion Criteria:

  • Any patient that is undergoing DSO or endothelial corneal transplantation vis DMEK or DSEK

Exclusion Criteria:

  • Patients that do not have an optical coherence tomography measurement pre- operatively
  • Patients that don't have an optical coherence tomography measurement post- operatively
  • Patients with a previous history of uncontrolled macular edema

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: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endothelial Dysfunction Cohort
All patients enrolled in the study will receive a baseline Optical Coherence Tomography scan (OCT) within 4 weeks prior to surgery. Two additional OCT scan will be performed 6 weeks and 3 months after surgery.
Diagnostic test: Optical Coherence Tomography
OCT is an imaging method that uses light waves to create images of the retina.
Other Names:
  • OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Post-Op CME
Time Frame: 6 weeks post-operative
The frequency (number of Subjects) of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO.
6 weeks post-operative
Incidence of Post-Op CME
Time Frame: 3 months post-operative
The frequency (number of Subjects) of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO.
3 months post-operative
Severity of Post-Op CME
Time Frame: 6 weeks post-operative
The severity of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO that experience Cystoid Macular Edema after surgery - measured by net change of Central Foveal Thickness on Optical Coherence Tomography (OCT- is an imaging technique that uses low-coherence light to capture micrometer-resolution, two- and three-dimensional images from within optical scattering media, e.g., biological tissue)
6 weeks post-operative
Severity of Post-Op CME
Time Frame: 3 months post-operative
The severity of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO that experience Cystoid Macular Edema after surgery - measured by net change of Central Foveal Thickness on Optical Coherence Tomography (OCT- is an imaging technique that uses low-coherence light to capture micrometer-resolution, two- and three-dimensional images from within optical scattering media, e.g., biological tissue)
3 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft Detachment
Time Frame: 6 weeks and 3 months post-operative
Frequency (number of Subjects) of post-operative graft detachment will be evaluated in patients that receive a corneal endothelial transplant.
6 weeks and 3 months post-operative
Re-bubbling Procedure
Time Frame: 6 weeks and 3 months post-operative
The incidence (number of Subjects) of re-bubbling procedures performed post-operatively will be evaluated.
6 weeks and 3 months post-operative
Infection
Time Frame: 6 weeks and 3 month post-operative
The incidence (number of Subjects) of post-operative infection will be evaluated.
6 weeks and 3 month post-operative
Final Visual Acuity
Time Frame: 3 months post-operative
The Snellen Visual Acuity test - This means that the test subject sees the same line of letters at 20 feet that person with normal vision sees at 20 feet. 20/40 vision means that the test subject sees at 20 feet what a person with normal vision sees at 40 feet.
3 months post-operative

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Matthew Giegengack, Wake Forest Health Sciences

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)

November 21, 2020

Primary Completion (Actual)

August 24, 2022

Study Completion (Actual)

August 24, 2022

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00067948

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will not be shared. Final, overall results will be reported for each outcome.

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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