OCT in Fuchs' Dystrophy

NCT04258787 | Recruiting

• 2 other identifiers: OHSU IRB#00020108R01EY029023-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fuchs Dystrophy; Pseudophakic Bullous Keratopathy

Keywords

Fuchs; Pseudophakic Bullous Keratopathy; Optical Coherence Tomography (OCT); PBK

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults age 18 or older with Fuchs' or PBK

You may qualify if:

• Damaged or diseased corneal endothelium from Fuchs' or PBK
• Willingness to commit to required study visits

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Winston Chamberlain, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Humberto Martinez, COT

CONTACT

503-494-7712; martinhu@ohsu.edu

Denzil Romfh, OD

CONTACT

503-494-4351; romfhd@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: June 26, 2020
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)