OCT-Based Screening for Early Retinal Changes in Asymptomatic Diabetic Patients
- Conditions
- Diabetic Macular Edema
- Registration Number
- NCT07232225
- Lead Sponsor
- Assiut University
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 112
- 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
- No significant abnormalities on fundus examination
- Intraocular pressure (IOP) below 21 mmHg
- Willing and able to provide written informed consent
- 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
- Uncooperative participants or those who decline to give consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of retinal thickness parameters between diabetic patients and healthy controls Baseline ( single assessment at the time of enrollment ) 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).
- Secondary Outcome Measures
Name Time Method Correlation between OCT changes and duration of diabetes/HbA1c level Baseline ( single assessment at the time of enrollment ) 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 %).