Analysis of Retinochoroidal Vasculature in Underweight Women Using Optical Coherence Tomography Angiography
1 other identifier
observational
48
1 country
1
Brief Summary
Cachectic patients and controls undergoing a comprehensive ophthalmologic examination. The imaging of all subjects is undertaken using a commercial OCTA device with a scan rate of 70,000 A-scans/s, scan beam wavelength of 840 ± 10 nm and bandwidth of 45 nm. All measurements are performed between 10:00 and 12:00 on the same day. The OCTA images are independently graded and assessed by two retinal specialists. The software automatically segmented these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedFirst Submitted
Initial submission to the registry
November 11, 2020
CompletedFirst Posted
Study publicly available on registry
November 17, 2020
CompletedNovember 18, 2020
November 1, 2020
3 months
November 11, 2020
November 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Choriocapillaris flow area
Choriocapillaris flow area assessed with optical coherence tomography angiography
10 minutes
Secondary Outcomes (4)
Subfoveal choroidal thickness
10 minutes
Vessel density
10 minutes
Foveal avascular zone
10 minutes
Subfoveal central macular thickness
10 minutes
Study Arms (2)
Underweight
Comprehensive ophthalmologic examination
Control
Comprehensive ophthalmologic examination
Interventions
Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and optical coherence tomography angiography imaging.
Eligibility Criteria
Study population includes a convenience sampling from the patients admitted to outpatient clinic between June 2020 and August 2020.
You may qualify if:
- Underweight (BMI \< 18.50 kg/m2).
You may not qualify if:
- refractive error \>+3.0 diopters (D) or \<-3.0 D spherical equivalent;
- poor image quality \<60 due to unstable fixation
- IOP \> 21 mm Hg
- longer AL (\>25 mm)
- pre-existing ophthalmic pathologies
- prior ocular surgery
- a systemic chronic disease that can cause underweight or retinopathy, such as cancer, malnutrition, and diabetes mellitus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aslı Çentinkaya Yaprak
Antalya, 070059, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 11, 2020
First Posted
November 17, 2020
Study Start
June 1, 2020
Primary Completion
August 30, 2020
Study Completion
August 30, 2020
Last Updated
November 18, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share