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OCT in Fuchs' Dystrophy

Sponsor
Oregon Health and Science University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04258787
Collaborator
National Eye Institute (NEI) (NIH)
60
Enrollment
1
Location
35.2
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography
    Actual Study Start Date :
    Jun 26, 2020
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Group A: No Surgery Group

    This group consists of adults ages 18 or older who have been diagnosed with Fuchs' dystrophy or pseudophakic bullous keratopathy but do not require surgery per standard-of-care guidelines.
    Group B: Surgery Group

    This group consists of adults ages 18 or older who have been diagnosed with Fuchs' dystrophy or pseudophakic bullous keratopathy, who require Descemet's Stripping Endothelial Keratoplasty (DSAEK), Descemet's Membrane Endothelial Keratoplasty (DMEK), or Descemet's Stripping Only (DSO) surgery. All treatment decisions will be made by the attending physician based on standard-of-care guidelines. (The study does not designate a treatment modality or pay for the treatment.)

    Outcome Measures

    Primary Outcome Measures

    1. Corneal Epithelial Edema/Haze [up to 2 years]

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

    2. Corneal Stromal Edema/Haze [up to 2 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Oregon Health and Science University
    • National Eye Institute (NEI)

    Investigators

    • Principal Investigator: Winston Chamberlain, MD, PhD, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Huang, Principal Investigator, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT04258787
    Other Study ID Numbers:
    • OHSU IRB#00020108
    • R01EY029023-01
    First Posted:
    Feb 6, 2020
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by David Huang, Principal Investigator, Oregon Health and Science University
    Fuchs
    Pseudophakic Bullous Keratopathy
    Optical Coherence Tomography (OCT)
    PBK
    Additional relevant MeSH terms:
    Fuchs' Endothelial Dystrophy

    Study Results

    No Results Posted as of Sep 23, 2021