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NCT06888765Completed

Effects of Differences in Body Composition on Retina and Choroid

The Impact of Changes in Body Composition on the Retina and Choroid

Source: ClinicalTrials.gov · Last updated 21 Mar 2025

Brief summary (registry, in English)

The goal of this observational study is to examine the effects of body composition differences on retinal and choroidal structures. The study aims to investigate how variations in fat distribution and body composition parameters influence ocular microvascular structures. The main questions it aims to answer are: * How do differences in body composition (BMI, waist circumference, bioelectrical impedance parameters) affect retinal and choroidal microvascular structures? * Are there significant structural changes in the retina and choroid among individuals with different body composition profiles? Participants will: * Be classified into five groups based on their Body Mass Index (BMI) (underweight, normal weight, overweight, obese, and severely/morbidly obese). * Undergo detailed body composition analysis using bioelectrical impedance analysis (BIA) to assess fat mass, muscle mass, visceral fat index, and metabolic age. * Receive comprehensive ophthalmologic evaluations, including Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA), to measure retinal thickness, choroidal thickness, and microvascular parameters. * OCTA images will be analyzed using the OCTAVA software to compute vascular parameters. This study does not involve any new treatments, drugs, or interventional procedures. The findings aim to provide insights into the relationship between body composition and ocular microvascular health, contributing to early detection and prevention strategies for obesity-related ocular complications.

Status (registry)
Completed
Study type
Observational
Enrollment
261 (actual)
First submitted
7 Mar 2025
Start date
1 Jul 2024
Primary completion date
1 Oct 2024
Lead sponsor
Bayram Meydan
Diseases
Obesity
NCT number
NCT06888765

What you commit to

  • Study type: Observational
  • Participants enrolled: 261
  • From 1 Jul 2024 to the primary completion date, 1 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of previous ocular surgery,
  • Use of medications that may affect choroidal or retinal vascular structures,
  • Presence of metallic prostheses, pacemakers, or other implants that could interfere with body composition analysis.

Other illness

  • Presence of ocular diseases such as glaucoma, uveitis, diabetic retinopathy, amblyopia, or retinal vein occlusion,

Other

  • Refractive error exceeding ±4 diopters,
  • Pregnancy or breastfeeding,

Who the study is looking for

  • Age between 18 and 65 years,
  • No detected pathology in routine ophthalmologic examination,
  • Providing written informed consent for participation.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duzce Univ. Fac. of Medicine, Dept. of Ophthalmology
Coordinator of this site? Confirm its status
DüzceTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.