OCT-Based Screening for Early Retinal Changes in Asymptomatic Diabetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-01-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Diabetic Macular Edema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Asymptomatic Diabetic Patients

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)

Spectral Domain OCT Imaging

Intervention Type DIAGNOSTIC_TEST

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.

Healthy Control Subjects

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)

Spectral Domain OCT Imaging

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes