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Clinical Trials/NCT02206594
NCT02206594
Completed
Not Applicable

Combined Cataract Surgery and Planned Descemetorhexis

Medical College of Wisconsin1 site in 1 country2 target enrollmentJanuary 2014
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ConditionsFuchs' Corneal DystrophyCataract

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fuchs' Corneal Dystrophy
Sponsor
Medical College of Wisconsin
Enrollment
2
Locations
1
Primary Endpoint
Corneal clarity as assessed by slit lamp photography
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of Fuchs' corneal dystrophy.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steve Koenig

Steven B. Koenig, MD

Medical College of Wisconsin

Eligibility Criteria

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)

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

Outcomes

Primary Outcomes

Corneal clarity as assessed by slit lamp photography

Time Frame: Assessed up to 1 year following descemetorhexis

Secondary Outcomes

  • Resolution of edema as assessed by slit lamp photography(Assessed up to 1 year following descemetorhexis)

Study Sites (1)

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