Recruiting

OCT

Sponsor:

Oregon Health and Science University

Code:

NCT04258787

Conditions

Fuchs Dystrophy

Pseudophakic Bullous Keratopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04258787

Start date

Jun 26, 2020

Status verified date

Sep, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.)

Primary outcome measure

  • Corneal Epithelial Edema/Haze [ Time Frame: up to 2 years ]
  • Corneal Stromal Edema/Haze [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

Denzil Romfh, OD

503-494-4351romfhd@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

Denzil Romfh, OD

503-494-4351romfhd@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-09-09.