Effects of Differences in Body Composition on Retina and Choroid

NCT06888765 | Completed

• 2 other identifiers: ETHICS-2024-1132024-113
• Study Type: observational
• Target: 261
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Obesity, Morbid; Body Composition

Keywords

Obesity; Retina; Choroid; Body Mass Index (BMI); Body Composition Analysis; Optical Coherence Tomography (OCT); Microvascular Structures

Outcome Measures

Primary Outcomes (5)

• Central Macular Thickness (CMT)

  Measurement of central macular thickness (CMT) in micrometers using spectral-domain Optical Coherence Tomography (OCT). The measurement focuses on the 1 mm central foveal region.

  Baseline (Cross-sectional)

• Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness

  Measurement of peripapillary RNFL thickness in micrometers using spectral-domain OCT. RNFL thickness is assessed around the optic disc at baseline.

  Baseline (Cross-sectional)

• Choroidal Thickness

  Subfoveal choroidal thickness (in micrometers) measured using Enhanced Depth Imaging OCT (EDI-OCT). Measurements are taken at the fovea and at predefined intervals (e.g., 500 µm, 1000 µm) on either side of the fovea.

  Baseline (Cross-sectional)

• Choroidal Vascularity Index (CVI)

  Calculation of the choroidal vascularity index (CVI) as the ratio of luminal area to total choroidal area in EDI-OCT images. Measurements are performed at the subfoveal region and analyzed using ImageJ software.

  Baseline (Cross-sectional)

• Retinal Microvascular Parameters (OCTA)

  Evaluation of retinal microvascular parameters using Optical Coherence Tomography Angiography (OCTA). Metrics include vascular density, vessel length, and foveal avascular zone (FAZ) area/circularity in both superficial and deep capillary plexuses.

  Baseline (Cross-sectional)

Secondary Outcomes (2)

• Composite Association Between Body Composition and Ocular Parameters

  Baseline

• Composite Regional Vascular Density Changes in Retinal and Choroidal Layers

  Baseline

Other Outcomes (8)

• FAZ Area

  Baseline

• FAZ Perimeter

  Baseline

• FAZ Circularity Index

  Baseline

Study Arms (5)

Underweight

Participants with BMI \<18.5

Other: Optical Coherence Tomography (OCT) and Body Composition Analysis

Normal Weight

Participants with BMI between 18.5 and 24.9

Other: Optical Coherence Tomography (OCT) and Body Composition Analysis

Overweight

Participants with BMI between 25 and 29.9

Other: Optical Coherence Tomography (OCT) and Body Composition Analysis

Obese

Participants with BMI between 30 and 34.9

Other: Optical Coherence Tomography (OCT) and Body Composition Analysis

Severely Obese

Participants with BMI \>35

Other: Optical Coherence Tomography (OCT) and Body Composition Analysis

Interventions

Optical Coherence Tomography (OCT) and Body Composition Analysis OTHER

This observational study included non-invasive diagnostic assessments to evaluate retinal, choroidal, ocular, and body composition parameters. Optical Coherence Tomography (OCT) measured macular and peripapillary retinal parameters, including retinal volume and cup/disc ratio. Enhanced Depth Imaging OCT (EDI-OCT) assessed choroidal thickness and vascularity, while Optical Coherence Tomography Angiography (OCTA) analyzed vessel density and foveal avascular zone (FAZ) metrics. Optical biometry measured axial length, anterior chamber depth, lens thickness, K1, K2, and central corneal thickness. Autorefractometry and tonometry were part of the routine ophthalmologic examination, including slit-lamp biomicroscopy. Bioelectrical impedance analysis (BIA) assessed body composition, including BMI, fat percentage, muscle mass, and metabolic age. These assessments were for research purposes only, without therapeutic intervention.

Normal Weight; Obese; Overweight; Severely Obese; Underweight

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study aims to evaluate changes in ocular microvascular structures in healthy individuals aged 18-65 years with different body mass index (BMI) categories. Participants included in the study have no systemic or ophthalmologic diseases, and their refractive error is within the ±4 diopter range.

You may qualify if:

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

You may not qualify if:

• Presence of ocular diseases such as glaucoma, uveitis, diabetic retinopathy, amblyopia, or retinal vein occlusion,
• History of previous ocular surgery,
• Refractive error exceeding ±4 diopters,
• Use of medications that may affect choroidal or retinal vascular structures,
• Pregnancy or breastfeeding,
• Presence of metallic prostheses, pacemakers, or other implants that could interfere with body composition analysis.

Sponsors & Collaborators

• Bayram Meydan: lead

Study Sites (1)

Duzce Univ. Fac. of Medicine, Dept. of Ophthalmology

Düzce, Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (3)

• Tapp RJ, Owen CG, Barman SA, Welikala RA, Foster PJ, Whincup PH, Strachan DP, Rudnicka AR; UK Biobank Eye, Vision Consortium. Retinal Vascular Tortuosity and Diameter Associations with Adiposity and Components of Body Composition. Obesity (Silver Spring). 2020 Sep;28(9):1750-1760. doi: 10.1002/oby.22885. Epub 2020 Jul 29.

  PMID: 32725961 BACKGROUND

• Ozgur G, Gokmen O. Associations between body mass index and choroidal thickness, superficial and deep retinal vascular indices, and foveal avascular zone measured by OCTA. Photodiagnosis Photodyn Ther. 2023 Jun;42:103515. doi: 10.1016/j.pdpdt.2023.103515. Epub 2023 Mar 14.

  PMID: 36924979 BACKGROUND

• Dogan B, Dogan U, Gedik B, Turkmen B, Cakir RC, Demirer ME, Aslaner A. Optical coherence tomography angiography evaluation of optic disc and retinal vascular densities in obese patients. Photodiagnosis Photodyn Ther. 2023 Dec;44:103826. doi: 10.1016/j.pdpdt.2023.103826. Epub 2023 Oct 4.

  PMID: 37797912 BACKGROUND

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• MURAT KAYA, Prof. Dr.

  Duzce University Faculty of Medicine, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

• BAYRAM MEYDAN, MD, Research Assistant

  Duzce University Faculty of Medicine, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant, MD

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 21, 2025
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)