OCT in Fuchs’ Dystrophy

Overview

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.

Full Title of Study: “Evaluating Corneal Edema in Fuchs’ Endothelial Dystrophy Using Optical Coherence Tomography”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2026

Arms, Groups and Cohorts

  • 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.)

Clinical Trial Outcome Measures

Primary Measures

  • Corneal Epithelial Edema/Haze
    • Time Frame: up to 2 years
    • OCT will be used to measure corneal epithelial edema/haze (in microns) in participants with Fuchs’ or PBK
  • Corneal Stromal Edema/Haze
    • Time Frame: up to 2 years
    • OCT will be used to measure corneal stromal edema/haze (in microns) in participants with Fuchs’ or PBK

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oregon Health and Science University
  • Collaborator
    • National Eye Institute (NEI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Huang, Principal Investigator – Oregon Health and Science University
  • Overall Official(s)
    • Winston Chamberlain, MD, PhD, Principal Investigator, Oregon Health and Science University
  • Overall Contact(s)
    • Humberto Martinez, COT, 503-494-7712, martinhu@ohsu.edu

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