OCT-Based Screening for Early Retinal Changes in Asymptomatic Diabetic Patients
ConditionDiabetic Macular Edema
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorAssiut University
About this trial
The goal of this observational study is to detect early retinal changes in people with diabetes who do not have visual symptoms. The study will use Optical Coherence Tomography (OCT) and fundus examination to screen for early retinal involvement in diabetic patients.
The main questions this study aims to answer are:
Can OCT detect early retinal changes before symptoms appear in people with diabetes?
Is fundus examination useful for identifying early diabetic retinal changes?
Participants will undergo a comprehensive eye examination, including OCT macular scans and fundus examination, at Assiut Ophthalmology Hospital. No treatment or invasive procedures will be performed as part of this study.
The collected data will help improve early detection and prevention of diabetic retinal complications.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least 6 months
Best-corrected visual acuity (BCVA) of 6/6 using Snellen chart
No visual symptoms (no blurred vision or metamorphopsia)
Clear ocular media allowing high-quality OCT imaging
Disqualifiers
History of previous macular disease or treatment (laser photocoagulation or intravitreal injection)
Media opacity that prevents adequate OCT imaging (e.g., dense cataract, corneal opacity)
Presence of other retinal diseases (e.g., age-related macular degeneration, retinal vein occlusion)
Systemic or neurological diseases that affect the retina or visual pathway
Trial population
Participants will be recruited from the Ophthalmology Department at Assiut Ophthalmology Hospital, Egypt. The study will include two groups: Group 1: Patients diagnosed with type 1 or type 2 diabetes mellitus for at least 6 months, without visual symptoms and with normal fundus examination findings. Group 2: Age- and sex-matched healthy individuals without diabetes, serving as controls. All participants will undergo a comprehensive ophthalmic examination, including best-corrected visual acuity testing, intraocular pressure measurement, fundus examination and spectral-domain optical coherence tomography (SD-OCT) imaging for retinal evaluation.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Spectral Domain OCT Imaging
Diagnostic testNon-invasive spectral domain optical coherence tomography(SD-0CT) imaging using a NIDEK RS-330 device to measure central macular , parafoveal, and perifoveal thickness and to assess the structural integrity and layers of the retina. This is a diagnostic procedure performed for observation only.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: Asymptomatic Diabetic Patients1 intervention
Group B: Healthy Control Subjects1 intervention
Trial outcomes
Primary outcomes
1
Comparison of retinal thickness parameters between diabetic patients and healthy controls
Measurement of central macular thickness (CMT), parafoveal, and perifoveal thickness (in micrometers) using Spectral Domain OCT and assessment of retinal layer structural integrity abnormalities (e.g., intraretinal fluid or hard exudates).
Time frame
Baseline ( single assessment at the time of enrollment )Secondary outcomes
1
Correlation between OCT changes and duration of diabetes/HbA1c level
Assessment of the statistical correlation between the measured retinal thickness parameters (CMT, parafoveal, and perifoveal thickness) and clinical variables, specifically the duration of diabetes mellitus (in years) and the latest recorded HbA1c level (in %).
Time frame
Baseline ( single assessment at the time of enrollment )Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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