An observational study in Diabetic Macular Edema, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Assiut University · Observational
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.
Diabetic retinopathy is a leading cause of vision impairment worldwide. Even in the absence of visual symptoms, patients with diabetes may already have early structural retinal changes that can be detected only with advanced imaging. Identifying these changes at an early stage is essential to prevent progression to vision-threatening complications.
This observational cross-sectional study aims to evaluate the role of Optical Coherence Tomography (OCT) and fundus examination in detecting early retinal changes among diabetic patients with no visual complaints. The study will be conducted at the Ophthalmology Department, Assiut University Hospitals, Egypt.
Eligible participants will include individuals with a confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least six months, best-corrected visual acuity of 6/6, clear ocular media, and no clinical evidence of retinal disease. A control group of healthy subjects with normal ocular findings will also be included for comparison.
All participants will undergo a complete ophthalmic assessment that includes:
Medical and ocular history, including diabetes duration and systemic status.
Visual acuity measurement (uncorrected and best-corrected) using the Snellen chart.
Anterior segment evaluation by slit-lamp biomicroscopy.
Fundus examination using slit-lamp biomicroscopy.
Spectral-domain OCT macular scanning (NIDEK RS-330, Japan) for assessment of macular thickness and retinal layer structure.
Data will be analyzed using SPSS software (Version 16). Quantitative variables will be expressed as mean ± standard deviation and compared using appropriate statistical tests. Correlations between OCT parameters, disease duration, and HbA1c levels will be evaluated.
The study is non-interventional and poses no significant risk to participants, as it involves only routine, non-invasive ophthalmic imaging. The findings are expected to improve early detection strategies for diabetic retinal changes and support the use of OCT and fundus examination as effective screening tools in routine diabetic eye care.
The estimated sample size will include approximately 112 participants (56 diabetic patients and 56 healthy controls).
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
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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.
Exclusion Criteria:
Patients diagnosed with Type 1or Type 2 Diabetes Mellitus for at least 6 months,BCVA 6/6, no visual symptoms, clear ocular media, no significant changes on fundus examination, and fulfilling all inclusion/exclusion criteria. (Total n=56)
Diagnostic Test: Spectral Domain OCT Imaging
Age-matched healthy subjects with no history of diabetes mellitus, BCVA 6/6, no visual symptoms, and fulfilling all study inclusion/exclusion criteria except for the diagnosis of diabetes. (Total n=56)
Diagnostic Test: Spectral Domain OCT Imaging
Non-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.
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 )
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 )
No study locations are listed for this record.
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Assiut University