OCT in Fuchs' Dystrophy

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Fuchs Dystrophy; Pseudophakic Bullous Keratopathy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04258787

OHSU IRB#00020108

R01EY029023-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

60 participants in 2 patient groups

Group A: No Surgery Group

Description:

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

Description:

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.)