Duzce Univ. Fac. of Medicine, Dept. of Ophthalmology
Düzce, 81620, Turkey (Türkiye)
NCT Number: NCT06888765
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.
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Notify Me18 year–65 year
All sexes
Observational
Düzce, 81620, Turkey (Türkiye)
Study Overview
This study is a prospective observational research planned to be conducted at Düzce University between July 1, 2024, and October 1, 2024. The aim of this study is to evaluate the potential effects of body composition differences on retinal and choroidal microvascular structures using non-invasive imaging techniques. The study is designed to investigate how obesity-related changes in fat distribution, metabolic parameters, and vascular structures may influence ocular health.
A total of 200 participants are planned to be enrolled, consisting of individuals who will visit the ophthalmology clinic for routine eye examinations and will be confirmed to have no pre-existing ocular pathologies. Participants will be classified into five groups based on Body Mass Index (BMI):
Each group is expected to include 40 participants.
Planned Study Procedures and Measurements Ophthalmologic Evaluations
All participants will undergo a comprehensive ophthalmologic examination, including:
Study Objectives and Clinical Significance
This study aims to determine the relationship between body composition differences and retinal/choroidal microvascular changes to better understand how systemic metabolic alterations influence ocular structures. The results are expected to contribute to:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline (Cross-sectional)
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.
Time frame: Baseline (Cross-sectional)
Measurement of peripapillary RNFL thickness in micrometers using spectral-domain OCT. RNFL thickness is assessed around the optic disc at baseline.
Time frame: Baseline (Cross-sectional)
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.
Time frame: Baseline (Cross-sectional)
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.
Time frame: Baseline (Cross-sectional)
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.
Time frame: Baseline
This composite outcome measure includes correlation analyses between BIA parameters (fat percentage, muscle mass, visceral fat, metabolic rate) and multiple ocular structures (central macular thickness, RNFL thickness, choroidal thickness, CVI). The aim is to determine whether body composition influences overall microvascular integrity.
Time frame: Baseline
This composite outcome measure evaluates retinal and choroidal vascular densities (VAD, VLD) in predefined ETDRS regions (foveal, parafoveal, perifoveal) using OCTA. The objective is to compare these densities across different BMI groups.
Time frame: Baseline
Measurement of the foveal avascular zone (FAZ) area (in mm²) using OCT Angiography to evaluate differences across BMI groups.
Time frame: Baseline
Measurement of the FAZ perimeter (in mm) using OCT Angiography to assess potential variations in foveal microcirculation among different BMI categories.
Time frame: Baseline
Assessment of FAZ shape using a circularity index. Higher values indicate a more circular FAZ. Comparisons will be made across underweight, normal, overweight, obese, and severely obese groups.
Time frame: Baseline
Comparison of axial length measurements among different BMI categories to identify possible associations with ocular morphology.
Time frame: Baseline
Spherical equivalent refraction (in diopters) measured using an autorefractometer. Differences across BMI categories will be assessed.
Time frame: Baseline
Intraocular pressure (IOP) measured in mmHg using a non-contact tonometer. Differences across BMI groups will be evaluated.
Time frame: Baseline
This outcome measure includes the measurement of waist circumference, hip circumference, and height. From these, waist-to-hip ratio (WHR) and waist-to-height ratio (WHtR) are calculated to assess central obesity. All measurements are performed following standardized protocols at baseline.
Time frame: Baseline
This outcome measure involves the analysis of body composition parameters using bioelectrical impedance analysis (BIA) with the Tanita BC-418 MA device. Parameters such as body weight, body mass index (BMI), total fat percentage, muscle mass, visceral fat, and basal metabolic rate are recorded. These data are compared across different BMI groups to evaluate overall body composition differences.
Bayram Meydan
Other
The Impact of Changes in Body Composition on the Retina and Choroid
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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.
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