OCT in Fuchs' Dystrophy

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT04258787
Status
Recruiting

Conditions

  • Fuchs Dystrophy
  • Pseudophakic Bullous Keratopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 26, 2020
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239
Humberto Martinez, COT
503-494-7712
Denzil Romfh, OD
503-494-4351
David Huang, MD, PhD (SUB_INVESTIGATOR)
Afshan Nanji, MD (SUB_INVESTIGATOR)
Richard Stutzman, MD (SUB_INVESTIGATOR)
Yan Li, PhD (SUB_INVESTIGATOR)

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