- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02223546
Circadian Macular Volume Changes in the Choroid (CVdi)
Pilotstudy: Diurnal Changes in Choroidal Volume
Studieoversikt
Status
Forhold
Detaljert beskrivelse
All patients undergo enhanced depth imaging (EDI) by the Spectralis SD-OCT device (Heidelberg Spectralis HRA2, Heidelberg Engineering, Heidelberg, Germany). SD-OCT measurements will be performed in both eyes after pupil dilation.
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Styria
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Graz, Styria, Østerrike, 8036
- Department of Ophthalmology, Medical University of Graz
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- age 18-65, signed informed consent form,
Exclusion Criteria:
- any ocular pathology, including history of ocular surgery or trauma, use of ocular medication, elevated intraocular pressure (IOP), or significant vitreous floaters. Further exclusion criteria were current use of any systemic medications, history of cardio-vascular disease, diabetes mellitus, or hypertension
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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healthy subject
healthy subject, every 3 hour measurement
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Macular Choroidal Volume
Tidsramme: daily average out of measurements every 3 hours within a 24 hour timeframe
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macular choroidal volume in the central 6mm
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daily average out of measurements every 3 hours within a 24 hour timeframe
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Subfoveal Choroidal Thickness
Tidsramme: daily average out of measurements every 3 hours within a 24 hour timeframe
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daily average out of measurements every 3 hours within a 24 hour timeframe
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean Ocular Perfusion Pressure
Tidsramme: every 3 hours within a 24 hour timeframe
|
mean arterial pressure (MAP) is defined as DBP + 1/3(SBP - DBP); mean ocular perfusion pressure results from 2/3(MAP - IOP).
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every 3 hours within a 24 hour timeframe
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Gerald Seidel, MD, Medical University of Graz
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CVdi
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