Combined Cataract Surgery and Planned Descemetorhexis

August 20, 2015 updated by: Steve Koenig, Medical College of Wisconsin
A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of Fuchs' corneal dystrophy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

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
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • The Medical College of Wisconsin

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

Description

General Inclusion Criteria:

  • Patient >18 years old
  • Willing and able to provide informed consent

Ocular Inclusion Criteria (all ocular inclusion criteria apply only to the study eye):

  • Fuchs' corneal dystrophy diagnosed
  • Cataract present
  • Best corrected visual acuity ≤ 20/40
  • Candidate for current endothelial transplant procedure (DSAEK, DMEK)

General Exclusion Criteria:

  • <18 years old
  • Medically unstable patient
  • Monocular patient
  • Unwilling or unable to provide informed consent

Ocular Exclusion Criteria (all ocular exclusion criteria apply only to the study eye):

  • Corneal dystrophy other than Fuchs'
  • Central corneal scar or central opacity not related to Fuchs'
  • Severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy
  • History of prior vitreoretinal surgery
  • Advanced or unstable glaucoma
  • Known steroid responders with glaucoma

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Descemetorhexis
Procedure: Descemetorhexis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corneal clarity as assessed by slit lamp photography
Time Frame: Assessed up to 1 year following descemetorhexis
Assessed up to 1 year following descemetorhexis

Secondary Outcome Measures

Outcome Measure
Time Frame
Resolution of edema as assessed by slit lamp photography
Time Frame: Assessed up to 1 year following descemetorhexis
Assessed up to 1 year following descemetorhexis

Other Outcome Measures

Outcome Measure
Time Frame
Reconstitution of the endothelial cell layer as assessed by specular microscopy
Time Frame: Assessed up to 1 year following descemetorhexis
Assessed up to 1 year following descemetorhexis

Collaborators and Investigators

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

Sponsor

Medical College of Wisconsin

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

January 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 18, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Estimate)

August 21, 2015

Last Update Submitted That Met QC Criteria

August 20, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCW-EI-001

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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