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OCT in Fuchs' Dystrophy

Recruiting
Conditions
Fuchs Dystrophy
Pseudophakic Bullous Keratopathy
Registration Number
NCT04258787
Lead Sponsor
Oregon Health and Science University
Brief Summary

This is an observational study using optical coherence tomography (OCT) technology to quantify corneal edema in Fuchs' endothelial dystrophy and predict refractive shift from resolving corneal edema after surgical treatments.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Damaged or diseased corneal endothelium from Fuchs' or PBK
  • Willingness to commit to required study visits
Exclusion Criteria
  • Prior Endothelial Keratoplasty (EK) or any other surgery except uncomplicated cataract surgery
  • Presence of a condition that increases the probability for treatment failure (e.g., heavily vascularized cornea, uncontrolled uveitis)
  • Other primary endothelial dysfunction conditions (e.g., posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy, iridocorneal endothelial syndrome)
  • Central sub-epithelial or stromal scarring that could impact post-operative clarity assessment
  • Peripheral anterior synechiae in the angle greater than 3 clock hours
  • Hypotony
  • Uncontrolled glaucoma
  • Visually significant optic nerve or macular pathology

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Corneal Stromal Edema/Hazeup to 2 years

OCT will be used to measure corneal stromal edema/haze (in microns) in participants with Fuchs' or PBK

Corneal Epithelial Edema/Hazeup to 2 years

OCT will be used to measure corneal epithelial edema/haze (in microns) in participants with Fuchs' or PBK

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Oregon Health & Science University

🇺🇸

Portland, Oregon, United States

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