Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04631978 |
| Other study ID # |
19102017-15/4-184 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
August 30, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Akdeniz University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Cachectic patients and controls undergoing a comprehensive ophthalmologic examination,
including the measurements of best-corrected visual acuity (BCVA), refractive error (KR-8900;
Topcon, Tokyo, Japan), intraocular pressure (IOP, Full Auto Tonometer TX-F; Topcon), axial
length (AL, Lenstar LS 900, Haag-Streit AG, Switzerland), slit lamp examination of the
anterior segment, dilated fundus examination, and OCTA imaging (Optovue RTVue XR 100 Avanti,
Freemont, California, USA) are included in the study. To calculate BMI, height is measured
using a standard anthropometric tape (Bioplus Stature Meter, model number IND/09/2005/815),
and a certified electronic weighing scale (model number Omron HN-283) is used to measure
weight.
According to the national guidelines, the patients are classified into two underweight
groups: Group 1 consisting of those with a BMI of <17.00 kg/m2 and Group 2 comprising those
with a BMI of 17.00 to 18.49 kg/m2. The control group is formed with individuals with a
normal BMI (18.50 to 24.99 kg/m2).
The right eye of each participant is included in the study. If the right eye meets any of the
exclusion criteria, then the left eye is selected for the sample. The inclusion criteria for
the patient group is being underweight (BMI < 18.50 kg/m2). The exclusion criteria for all
groups are as follows: 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; and a systemic chronic disease
that can cause underweight or retinopathy, such as cancer, malnutrition, and diabetes
mellitus.
OCTA
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. This device can
perform 70 000 A-scans/s per second to acquire volumes of 304 × 304 A-scans. All measurements
are performed between 10:00 and 12:00 on the same day.
To evaluate the vascular structures, 6×6 mm OCTA software is used. The split-spectrum
amplitude decorrelation angiography (SSADA) algorithm is performed in all participants. The
images of poor quality (signal strength index (SSI) < 8) with either significant motion
artifact or incorrect segmentation are excluded. 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. The same software also
calculates the flow index rates in a central circular zone of 3.144 mm² in the outer retina
and CC segments. Choroidal thickness is calculated manually by two retinal specialists, and
the average value was used.
