An observational study in Cachexia and Underweight, sponsored by Akdeniz University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-18.
Sponsored by Akdeniz University · Observational
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.
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.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's enrollment of 48 is below the median of 150 across 88 observational studies indexed under Cachexia.
Browse Cachexia studies →Akdeniz University is the lead sponsor of 297 studies on the registry; 62 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study population includes a convenience sampling from the patients admitted to outpatient clinic between June 2020 and August 2020.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Comprehensive ophthalmologic examination
Diagnostic Test: Comprehensive ophthalmologic examination
Comprehensive ophthalmologic examination
Diagnostic Test: Comprehensive ophthalmologic examination
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.
Choriocapillaris flow area
Choriocapillaris flow area assessed with optical coherence tomography angiography
Time frame: 10 minutes
Subfoveal choroidal thickness
Subfoveal choroidal thickness assessed with optical coherence tomography angiography
Time frame: 10 minutes
Vessel density
Vessel density assessed with optical coherence tomography angiography
Time frame: 10 minutes
Foveal avascular zone
Foveal avascular zone assessed with optical coherence tomography angiography
Time frame: 10 minutes
Subfoveal central macular thickness
Subfoveal central macular thickness assessed with optical coherence tomography angiography
Time frame: 10 minutes
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2020 to primary completion in Aug 2020, 2 months.
Of 38 observational studies under Cachexia, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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