Simultaneous OCT and B-FAF in Eyes With Alteration of the Foveal Contour
NCT ID: NCT03287648
Last Updated: 2021-01-20
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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UNKNOWN
20 participants
OBSERVATIONAL
2017-06-01
2024-05-20
Brief Summary
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The aim of the study is to evaluate in detail these alterations recording simultaneously OCT and B-FAF.
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Detailed Description
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The OCT recording protocol will consist of a sequence of 37 horizontal sections, spaced 120-µm apart, covering an area of 20° or 30° horizontally by 15° vertically, and a sequence of 24 radial sections recorded in the high-resolution (HR) mode simultaneously with infrared (IR) images.
In addition, simultaneous B-FAF/OCT images will be acquired (horizontal, and vertical OCT sections, centered on the fovea and recorded in the HR mode).
The same OCT/FAF protocol will be used for the study eye and for the fellow eye.
For the study eyes that had been examined in the past, the ''Follow-up'' function will be used in addition to the prespecified protocol to evaluate if any changes had occurred since the last scan.
Multiple other morphological characteristics will be analyzed using OCT imaging, including the status of the posterior cortex, the presence of operculum, the integrity/disruption of the external limiting membrane (ELM), ellipsoid zone (EZ), and the central and minimal foveal thickness (CFT and mFT respectively). The latter will be defined as the thinnest part of the fovea within the foveal pit identified by examining radial scans whereas the former will be measured in relation to the highest point of the foveal bulge.
All measurements will be performed using the Spectralis built-in manual caliper function at high magnification after adjusting the scale to 1:1 µm except for CFT, which will be calculated using the automated ''thickness map'' function of the Heidelberg Eye Explorer.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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optical coherence tomography and blue-fundus autofluorescence
Simultaneous infra-red and optical coherence tomography (cube and radial pattern) centered on the fovea Simultaneous fundus autofluorescence and optical coherence tomography (radial pattern) centered on the fovea
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* focal, well-defined increased autofluorescence signal at the fovea
Exclusion Criteria
* juxtafoveal telangiectasia
* ring of increased B-FAF
* vitelliform and pseudovitelliform lesions
* history of diabetes, retinal vein occlusion, uveitis, CSR, AMD or any other retinal -disease potentially associated with intra or subretinal fluid
* macular drusen
* history of submacular hemorrhage
20 Years
90 Years
ALL
No
Sponsors
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University of Milan
OTHER
University of Molise
OTHER
Responsible Party
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Roberto dell'Omo
Associate Professor
Locations
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University of Molise
Campobasso, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0004/2017
Identifier Type: -
Identifier Source: org_study_id
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