Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2020-06-26
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Willingness to commit to required study visits
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Oregon Health and Science University
OTHER
Responsible Party
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David Huang
Principal Investigator
Principal Investigators
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Winston Chamberlain, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health & Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OHSU IRB#00020108
Identifier Type: -
Identifier Source: org_study_id
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