RecruitingNCT04258787Updated Sep 9, 2025

OCT in Fuchs' Dystrophy

An observational study in Fuchs Dystrophy and Pseudophakic Bullous Keratopathy, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Oregon Health and Science University · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 60
Ages: 18 Years and older
Sex: All

Study 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 studied

Fuchs Dystrophy
Pseudophakic Bullous Keratopathy

Browse trials for

Fuchs' Endothelial Dystrophy 90

Keywords

Fuchs
Pseudophakic Bullous Keratopathy
Optical Coherence Tomography (OCT)
PBK

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Adults age 18 or older with Fuchs' or PBK

Inclusion criteria

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

Exclusion criteria

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

Observational model: Case-control
Time perspective: Prospective
Enrollment: 60 participants (estimated)
Patient registry: No

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.)

What researchers measure

Primary outcomes

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

Study locations

1 of 1 sites recruiting

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT04258787
Lead sponsor: Oregon Health and Science University
Collaborators: National Eye Institute (NEI)
Responsible party: David Huang (Principal Investigator, Oregon Health and Science University) — Principal investigator
First posted: Feb 6, 2020
Start date: Jun 26, 2020
Primary completion: Jun 2027 (estimated)
Completion: Jun 2028 (estimated)
Last update: Sep 9, 2025

Study contacts

Humberto Martinez, COT

Contact

martinhu@ohsu.edu

503-494-7712

Denzil Romfh, OD

Contact

romfhd@ohsu.edu

503-494-4351

Winston Chamberlain, MD, PhD

principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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