About this trial
The specific aims of the clinical studies are to:
* Develop a directional high-resolution OCT and OCT angiography prototype to improve imaging of structure and perfusion. * Validate wide-field OCT and OCT angiography parameters to improve early glaucoma detection. * Simulate visual field results by combining structural and angiography OCT data. * Assess abilities of above technologies and OCT-derived parameters on predicting glaucoma detection, conversion, and progression.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
No history or evidence of retinal pathology or glaucoma
Normal Humphrey 24-2 VF: A mean defect (MD), corrected pattern standard deviation (CPSD) within 95% limits of normal reference, and glaucoma hemifield test (GHT) within normal limits (97%).
Intraocular pressure < 21 mm Hg
Central corneal pachymetry > 500 microns
Disqualifiers
Best-corrected visual acuity less than 20/40
Age < 40 or >85 years
Refractive error of > +3.00 D or < -7.00 D
Previous intraocular surgery except for uncomplicated keratorefractive surgery and cataract extraction with posterior chamber intraocular lens implantation
Trial population
The study will enroll both males and females and include all ethnic and racial groups through clinical practices in the centers. The study will enroll subjects in the older adult age range commonly affected by glaucoma - 40 years or older. The study will exclude people with life-threatening or debilitating illness that would make 5-year participation unlikely or cooperation with tests difficult. For similar reasons those older than 85 years are excluded. The study also excludes those with any disease that might confound the diagnosis of glaucoma. Otherwise people with any health status are eligible for enrollment. Two groups of participants are recruited in the study: healthy controls or participants with confirmed glaucoma.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Measure of retinal non-perfusion areas in mm2
Measure vessel density in percentage (%)
Determine accuracy of sector visual field progression in OCT-based sector visual field simulation compared to actual visual field results. Measured in dB change over time.
Sponsors and contacts
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Oregon Health and Science University
Lead sponsor
National Eye Institute (NEI)
Collaborator