Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
15 participants
OBSERVATIONAL
2013-10-31
2014-02-28
Brief Summary
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Detailed Description
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Scanning Protocol: This studies choroidal volume measurement protocol has been previously published. In short, 31 high resolution B-scans centered at the fovea will be obtained by a single investigator. To optimize image quality each B-scan will be averaged from at least 25 individual scans using the build in eye tracking software (TrueTrack, Heidelberg Engineering, Heidelberg, Germany). Scan length will be set to 9.3mm and spacing to 240µm, resulting in a 30x25 degree area around the fovea.
Each individual will undergo SD-OCT measurement every 3 hours within a 24 hour timeframe (at 0, 3, 6, 9 12, 15, 18, and 21 o'clock; 8 times total). Additionally, automated blood pressure measurement and Goldmann applanation tonometry will be performed every 3 hours. Subject will be instructed to sleep in erect position from 21 to 6 o'clock, and will be awoken for examination at 0 and 3.
OCT Analysis: Two retinal specialists will manually adjust the segmentation lines for automated choroidal volume calculation by the devices build in software. Choroidal thickness is defined as the layer between the outer boarder of the retinal pigment epithelium (RPE) and the hyper reflective layer behind the large vessels of the choroid (chorio-scleral interface). The devices Software thus generates a three-dimensional choroidal thickness map, divided according to the Early Treatment Diabetic Retinopathy Study (EDTRS) grid. In addition to this, subfoveal choroidal thickness will be measured manually using the SD-OCTs integrated caliper tool, drawing a perpendicular line to the RPE within the aforementioned bounds.
This is considered a pilot study, so explorative data analysis will be performed.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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healthy subject
healthy subject, every 3 hour measurement
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Gerald Seidel, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
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Department of Ophthalmology, Medical University of Graz
Graz, Styria, Austria
Countries
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Related Links
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PMID 25447108
Other Identifiers
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CVdi
Identifier Type: -
Identifier Source: org_study_id
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