OCT in Fuchs' Dystrophy

Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography

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.

Study Overview

• Status: Recruiting
• Conditions: Fuchs Dystrophy; Pseudophakic Bullous Keratopathy

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Humberto Martinez, COT; Phone Number: 503-494-7712; Email: martinhu@ohsu.edu
• Study Contact Backup: Name: Denzil Romfh, OD; Phone Number: 503-494-4351; Email: romfhd@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Sub-Investigator: David Huang, MD, PhD
      • Contact: Humberto Martinez, COT; Phone Number: 503-494-7712; Email: martinhu@ohsu.edu
      • Contact: Denzil Romfh, OD; Phone Number: 503-494-4351; Email: romfhd@ohsu.edu
      • Sub-Investigator: Afshan Nanji, MD
      • Sub-Investigator: Richard Stutzman, MD
      • Sub-Investigator: Yan Li, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults age 18 or older with Fuchs' or PBK

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: Winston Chamberlain, MD, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography (OCT); Fuchs; Pseudophakic Bullous Keratopathy; PBK
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: OHSU IRB#00020108; R01EY029023-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No