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

November 14, 2025 updated by: Abanoub Rafaat Marsis Rizkallah, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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.
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of retinal thickness parameters between diabetic patients and healthy controls
Time Frame: 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).
Baseline ( single assessment at the time of enrollment )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between OCT changes and duration of diabetes/HbA1c level
Time Frame: 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 %).
Baseline ( single assessment at the time of enrollment )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • OCT DME

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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