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NCT Number: NCT04258787

OCT in Fuchs' Dystrophy

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.

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Key information

Conditions

Fuchs Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn Pseudophakic Bullous Keratopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Afshan Nanji, MD

SUB_INVESTIGATOR

David Huang, MD, PhD

SUB_INVESTIGATOR

Denzil Romfh, OD

CONTACT

[email protected]

503-494-4351

Humberto Martinez, COT

CONTACT

[email protected]

503-494-7712

Richard Stutzman, MD

SUB_INVESTIGATOR

Yan Li, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Denzil Romfh, OD

CONTACT

[email protected]

503-494-4351

Humberto Martinez, COT

CONTACT

[email protected]

503-494-7712

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Feb 6, 2020
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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