OCT in Fuchs' Dystrophy

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04258787

Enrollment

Registered

2020-02-06

Start date

2020-06-26

Completion date

2028-06-30

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs Dystrophy, Pseudophakic Bullous Keratopathy

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Countries

United States

Contacts

Primary ContactHumberto Martinez, COT

martinhu@ohsu.edu503-494-7712

Backup ContactDenzil Romfh, OD

romfhd@ohsu.edu503-494-4351

Outcome results