OCT in Fuchs' Dystrophy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
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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.) |
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Damaged or diseased corneal endothelium from Fuchs' or PBK
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Willingness to commit to required study visits
Exclusion Criteria:
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Prior Endothelial Keratoplasty (EK) or any other surgery except uncomplicated cataract surgery
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Presence of a condition that increases the probability for treatment failure (e.g., heavily vascularized cornea, uncontrolled uveitis)
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Other primary endothelial dysfunction conditions (e.g., posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy, iridocorneal endothelial syndrome)
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Central sub-epithelial or stromal scarring that could impact post-operative clarity assessment
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Peripheral anterior synechiae in the angle greater than 3 clock hours
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Hypotony
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Uncontrolled glaucoma
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Visually significant optic nerve or macular pathology
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Oregon Health and Science University
- National Eye Institute (NEI)
Investigators
- Principal Investigator: Winston Chamberlain, MD, PhD, Oregon Health and Science University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OHSU IRB#00020108
- R01EY029023-01