ObesityNCT06888765
Effects of Differences in Body Composition on Retina and Choroid
An observational study of Obesity and Obesity, Morbid, run by Bayram Meydan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Obesity, Morbid, Body Composition
- What is being tested?
- Optical Coherence Tomography (OCT) and Body Composition Analysis
- How many people
- 261 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Jan 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age between 18 and 65 years,
- No detected pathology in routine ophthalmologic examination,
- Providing written informed consent for participation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce Univ. Fac. of Medicine, Dept. of Ophthalmology
Düzce, Düzce, 81620
About this study
Official title: The Impact of Changes in Body Composition on the Retina and Choroid
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:
Read more
- 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.
Read the detailed description
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):
- Group 1: Underweight (BMI <18.5)
- Group 2: Normal weight (BMI 18.5-24.9)
- Group 3: Overweight (BMI 25-29.9)
- Group 4: Obese (BMI 30-34.9)
- Group 5: Severely/Morbidly Obese (BMI >35)
Each group is expected to include 40 participants.
Planned Study Procedures and Measurements Ophthalmologic Evaluations
All participants will undergo a comprehensive ophthalmologic examination, including:
- Autorefractometry to assess refractive errors
- Intraocular pressure (IOP) measurement using a non-contact tonometer
- Detailed slit-lamp biomicroscopy to examine anterior and posterior segment structures Body Composition Analysis
- Bioelectrical Impedance Analysis (BIA) will be performed to assess:
- Total body fat percentage, visceral fat index, muscle mass, and metabolic age
- Segmental body composition (fat and muscle mass in arms, legs, and trunk)
- Extracellular and intracellular water distribution
- Waist circumference, waist-to-hip ratio, waist-to-height ratio OCT and OCTA Imaging
- Optical Coherence Tomography (OCT) and Enhanced Depth Imaging-OCT (EDI-OCT) will be used to obtain:
- Macular and peripapillary retinal thickness measurements
- Retinal nerve fiber layer (RNFL) thickness
- Optic disc and cup-to-disc ratio analysis
- Choroidal thickness at the subfoveal region and 500 µm intervals
- Optical Coherence Tomography Angiography (OCTA) will be performed to analyze:
- Superficial and deep retinal capillary plexus vascular density
- Foveal avascular zone (FAZ) area, perimeter, and circularity
- Vascular tortuosity and branchpoint density Image Processing and Analysis
- OCTA images will be analyzed using the OCTAVA software, where:
- Vessel area density, vessel length density, total vessel length, mean vessel diameter, median vessel diameter, branchpoint density, fractal dimension, and vessel tortuosity will be calculated.
- FAZ metrics (FAZ area, perimeter, and circularity) and vascular density values will be evaluated using ETDRS grid segmentation and FD-300 analysis.
- Choroidal Vascularity Index (CVI) will be calculated from EDI-OCT images using ImageJ software.
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:
- Identifying early ocular biomarkers associated with obesity
- Developing preventive strategies for obesity-related retinal and choroidal complications
- Enhancing the clinical use of non-invasive imaging techniques in metabolic disease monitoring No new treatment, drug, or interventional procedure is planned to be applied in this study, and no life-threatening risks are anticipated.
- Conditions
- Obesity, Obesity, Morbid, Body Composition
- Being tested
- Optical Coherence Tomography (OCT) and Body Composition Analysis
- Keywords
- Obesity, Retina, Choroid, Body Mass Index (BMI), Body Composition Analysis, Optical Coherence Tomography (OCT), Microvascular Structures
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography (OCT) and Body Composition AnalysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Underweight | Participants with BMI <18.5 Receives: Other: Optical Coherence Tomography (OCT) and Body Composition Analysis | |
| Normal Weight | Participants with BMI between 18.5 and 24.9 Receives: Other: Optical Coherence Tomography (OCT) and Body Composition Analysis | |
| Overweight | Participants with BMI between 25 and 29.9 Receives: Other: Optical Coherence Tomography (OCT) and Body Composition Analysis | |
| Obese | Participants with BMI between 30 and 34.9 Receives: Other: Optical Coherence Tomography (OCT) and Body Composition Analysis | |
| Severely Obese | Participants with BMI >35 Receives: Other: Optical Coherence Tomography (OCT) and Body Composition Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Cross-sectional)
Secondary outcomes (2)
Composite Association Between Body Composition and Ocular Parameters
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.
Measured: Baseline
Composite Regional Vascular Density Changes in Retinal and Choroidal Layers
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Jul 2024
- Primary completion1 Oct 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayram Meydan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bayram Meydan, Duzce University
- Investigators
- MURAT KAYA, Prof. Dr., Principal investigator, Duzce University Faculty of Medicine, Department of OphthalmologyBAYRAM MEYDAN, MD, Research Assistant, Principal investigator, Duzce University Faculty of Medicine, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888765
- Sponsor's protocol ID
- ETHICS-2024-113
- Other IDs
- 2024-113
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical considerations and data privacy regulations. The collected data contain sensitive personal health information, and sharing them could potentially violate patient confidentiality and institutional policies. Additionally, there are no plans for a public data repository for this study.
Publications
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.
PubMed 32725961Ozgur 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.
PubMed 36924979Dogan 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.
PubMed 37797912
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Changes in Body Composition on the Retina and Choroid
- ClinicalTrials.gov ID
- NCT06888765
- Acronym / sponsor ID
- ETHICS-2024-113
- Conditions
- Obesity, Obesity, Morbid, Body Composition
- Keywords
- Obesity, Retina, Choroid, Body Mass Index (BMI), Body Composition Analysis, Optical Coherence Tomography (OCT), Microvascular Structures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Bayram MeydanUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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):
- Group 1: Underweight (BMI <18.5)
- Group 2: Normal weight (BMI 18.5-24.9)
- Group 3: Overweight (BMI 25-29.9)
- Group 4: Obese (BMI 30-34.9)
- Group 5: Severely/Morbidly Obese (BMI >35)
Each group is expected to include 40 participants.
Planned Study Procedures and Measurements Ophthalmologic Evaluations
All participants will undergo a comprehensive ophthalmologic examination, including:
- Autorefractometry to assess refractive errors
- Intraocular pressure (IOP) measurement using a non-contact tonometer
- Detailed slit-lamp biomicroscopy to examine anterior and posterior segment structures Body Composition Analysis
- Bioelectrical Impedance Analysis (BIA) will be performed to assess:
- Total body fat percentage, visceral fat index, muscle mass, and metabolic age
- Segmental body composition (fat and muscle mass in arms, legs, and trunk)
- Extracellular and intracellular water distribution
- Waist circumference, waist-to-hip ratio, waist-to-height ratio OCT and OCTA Imaging
- Optical Coherence Tomography (OCT) and Enhanced Depth Imaging-OCT (EDI-OCT) will be used to obtain:
- Macular and peripapillary retinal thickness measurements
- Retinal nerve fiber layer (RNFL) thickness
- Optic disc and cup-to-disc ratio analysis
- Choroidal thickness at the subfoveal region and 500 µm intervals
- Optical Coherence Tomography Angiography (OCTA) will be performed to analyze:
- Superficial and deep retinal capillary plexus vascular density
- Foveal avascular zone (FAZ) area, perimeter, and circularity
- Vascular tortuosity and branchpoint density Image Processing and Analysis
- OCTA images will be analyzed using the OCTAVA software, where:
- Vessel area density, vessel length density, total vessel length, mean vessel diameter, median vessel diameter, branchpoint density, fractal dimension, and vessel tortuosity will be calculated.
- FAZ metrics (FAZ area, perimeter, and circularity) and vascular density values will be evaluated using ETDRS grid segmentation and FD-300 analysis.
- Choroidal Vascularity Index (CVI) will be calculated from EDI-OCT images using ImageJ software.
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:
- Identifying early ocular biomarkers associated with obesity
- Developing preventive strategies for obesity-related retinal and choroidal complications
- Enhancing the clinical use of non-invasive imaging techniques in metabolic disease monitoring No new treatment, drug, or interventional procedure is planned to be applied in this study, and no life-threatening risks are anticipated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Underweight | – | Other: Optical Coherence Tomography (OCT) and Body Composition AnalysisParticipants with BMI <18.5 |
| Normal Weight | – | Other: Optical Coherence Tomography (OCT) and Body Composition AnalysisParticipants with BMI between 18.5 and 24.9 |
| Overweight | – | Other: Optical Coherence Tomography (OCT) and Body Composition AnalysisParticipants with BMI between 25 and 29.9 |
| Obese | – | Other: Optical Coherence Tomography (OCT) and Body Composition AnalysisParticipants with BMI between 30 and 34.9 |
| Severely Obese | – | Other: Optical Coherence Tomography (OCT) and Body Composition AnalysisParticipants with BMI >35 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age between 18 and 65 years,
- No detected pathology in routine ophthalmologic examination,
- Providing written informed consent for participation.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence Tomography (OCT) and Body Composition AnalysisThis 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. | Other | Normal Weight, Obese, Overweight, Severely Obese, Underweight |
Primary outcome
Central Macular Thickness (CMT)
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.
Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness
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.
Choroidal Thickness
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.
Choroidal Vascularity Index (CVI)
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.
Retinal Microvascular Parameters (OCTA)
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.
2 secondary outcomes
Composite Association Between Body Composition and Ocular Parameters
Time frame: Baseline
Composite Regional Vascular Density Changes in Retinal and Choroidal Layers
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Results publication: PubMed 32725961Tapp 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.
- Results publication: PubMed 36924979Ozgur 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.
- Results publication: PubMed 37797912Dogan 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical considerations and data privacy regulations. The collected data contain sensitive personal health information, and sharing them could potentially violate patient confidentiality and institutional policies. Additionally, there are no plans for a public data repository for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MURAT KAYA, Prof. Dr. principal investigator
Duzce University Faculty of Medicine, Department of Ophthalmology
BAYRAM MEYDAN, MD, Research Assistant principal investigator
Duzce University Faculty of Medicine, Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity, Morbid, run by Bayram Meydan 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 3 inclusion and 6 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 21 Mar 2025. 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?
Central Macular Thickness (CMT) (time frame: Baseline (Cross-sectional)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06888765, which also lists 3 linked publications.
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 21 Mar 2025.