OCT in Fuchs' Dystrophy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Damaged or diseased corneal endothelium from Fuchs' or PBK
Willingness to commit to required study visits
Disqualifiers
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
Trial population
Adults age 18 or older with Fuchs' or PBK
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Group A: No Surgery Group
Group B: Group B: Surgery Group
Trial outcomes
Primary outcomes
1
Corneal Epithelial Edema/Haze
OCT will be used to measure corneal epithelial edema/haze (in microns) in participants with Fuchs' or PBK
Time frame
up to 2 years2
Corneal Stromal Edema/Haze
OCT will be used to measure corneal stromal edema/haze (in microns) in participants with Fuchs' or PBK
Time frame
up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
National Eye Institute (NEI)
Collaborator
Source ClinicalTrials.gov