Skip to main content
OpenTrials
Completed

NCT Number: NCT04631978

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aslı Çentinkaya Yaprak

Antalya, 070059, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Underweight (BMI < 18.50 kg/m2).

Exclusion criteria

  • 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.

Treatment and study plan

Comprehensive ophthalmologic examination

Diagnostic 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.

Primary outcomes

  1. Choriocapillaris flow area

    Time frame: 10 minutes

    Choriocapillaris flow area assessed with optical coherence tomography angiography

Secondary outcomes

  1. Subfoveal choroidal thickness

    Time frame: 10 minutes

    Subfoveal choroidal thickness assessed with optical coherence tomography angiography

  2. Vessel density

    Time frame: 10 minutes

    Vessel density assessed with optical coherence tomography angiography

  3. Foveal avascular zone

    Time frame: 10 minutes

    Foveal avascular zone assessed with optical coherence tomography angiography

  4. Subfoveal central macular thickness

    Time frame: 10 minutes

    Subfoveal central macular thickness assessed with optical coherence tomography angiography

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2020
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.