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Combined Cataract Surgery and Planned Descemetorhexis

Not Applicable
Completed
Conditions
Fuchs' Corneal Dystrophy
Cataract
Interventions
Procedure: Descemetorhexis
Registration Number
NCT02206594
Lead Sponsor
Medical College of Wisconsin
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
DescemetorhexisDescemetorhexis-
Primary Outcome Measures
NameTimeMethod
Corneal clarity as assessed by slit lamp photographyAssessed up to 1 year following descemetorhexis
Secondary Outcome Measures
NameTimeMethod
Resolution of edema as assessed by slit lamp photographyAssessed up to 1 year following descemetorhexis

Trial Locations

Locations (1)

The Medical College of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

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