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CachexiaNCT04631978

Analysis of Retinochoroidal Vasculature in Underweight Women Using Optical Coherence Tomography Angiography

An observational study of Cachexia and Underweight, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Cachexia, Underweight
What is being tested?
Comprehensive ophthalmologic examination
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2020to 30 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Study population includes a convenience sampling from the patients admitted to outpatient clinic between June 2020 and August 2020.

Who may be able to join

  • Underweight (BMI < 18.50 kg/m2).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Aslı Çentinkaya Yaprak

    Antalya, 070059

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed 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.

Being tested
Comprehensive ophthalmologic examination
Medical subject headings
Cachexia, Thinness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive ophthalmologic examinationDiagnostic test

    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.

Study groups in NCT04631978
Study groupRoleWhat they receive
UnderweightComprehensive ophthalmologic examination
Receives: Diagnostic Test: Comprehensive ophthalmologic examination
ControlComprehensive ophthalmologic examination
Receives: Diagnostic Test: Comprehensive ophthalmologic examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Choriocapillaris flow area

    Choriocapillaris flow area assessed with optical coherence tomography angiography

    Measured: 10 minutes

Secondary outcomes (4)
  1. Subfoveal choroidal thickness

    Subfoveal choroidal thickness assessed with optical coherence tomography angiography

    Measured: 10 minutes

  2. Vessel density

    Vessel density assessed with optical coherence tomography angiography

    Measured: 10 minutes

  3. Foveal avascular zone

    Foveal avascular zone assessed with optical coherence tomography angiography

    Measured: 10 minutes

  4. Subfoveal central macular thickness

    Subfoveal central macular thickness assessed with optical coherence tomography angiography

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start1 Jun 2020
  3. Primary completion30 Aug 2020
  4. Study completion30 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04631978
Sponsor's protocol ID
19102017-15/4-184
Status last verified
Nov 2020
First submitted
11 Nov 2020
Last updated
18 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cachexia and Underweight, run by Akdeniz University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Choriocapillaris flow area (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.

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