Diabetic Macular EdemaDREAM-OCTNCT07232225
OCT-Based Screening for Early Retinal Changes in Asymptomatic Diabetic Patients
An observational study of Diabetic Macular Edema, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Spectral Domain OCT Imaging
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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.
Read the 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).
- Conditions
- Diabetic Macular Edema
- Being tested
- Spectral Domain OCT Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral Domain OCT ImagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Spectral Domain OCT Imaging | |
| 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) Receives: Diagnostic Test: Spectral Domain OCT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 %).
Measured: Baseline ( single assessment at the time of enrollment )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Rafaat Marsis Rizkallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232225
- Sponsor's protocol ID
- OCT DME
- Acronym
- DREAM-OCT
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gu Q, Pan T, Cheng R, Huang J, Zhang K, Zhang J, Yang Y, Cheng P, Liu Q, Shen H. Macular vascular and photoreceptor changes for diabetic macular edema at early stage. Sci Rep. 2024 Sep 4;14(1):20544. doi: 10.1038/s41598-024-71286-6.
PubMed 39232012Kim JT, Lee MW. Longitudinal changes in each retinal layer thickness in patients with moderate or more severe diabetic retinopathy taking calcium dobesilate. PLoS One. 2025 Jun 4;20(6):e0325655. doi: 10.1371/journal.pone.0325655. eCollection 2025.
PubMed 40465771Aldakhil S, Challa N, Alhoshan SA, Abohaimed F, Alnasser BN, Almuhawas HA, AlObaisi S, Alrasheed SH. Quantitative Analysis of Early Retinal Changes and OCT Parameters in Diabetic Subjects with and Without Retinopathy. Diagnostics (Basel). 2025 Feb 13;15(4):451. doi: 10.3390/diagnostics15040451.
PubMed 40002602Kalaw FGP, Sharma P, Walker E, Borooah S. Differences in macular thickness associated with peripheral retinal vessel whitening in diabetic patients. Sci Rep. 2024 Aug 27;14(1):19881. doi: 10.1038/s41598-024-68839-0.
PubMed 39191790Endo H, Kase S, Tanaka H, Takahashi M, Katsuta S, Suzuki Y, Fujii M, Ishida S, Kase M. Factors based on optical coherence tomography correlated with vision impairment in diabetic patients. Sci Rep. 2021 Feb 4;11(1):3004. doi: 10.1038/s41598-021-82334-w.
PubMed 33542264Shah J, Tan B, Wong D, Abdul Gani NFB, Hu Q, Liu X, Chua J. Evaluation of thickness of individual macular retinal layers in diabetic eyes from optical coherence tomography. Sci Rep. 2024 Aug 2;14(1):17909. doi: 10.1038/s41598-024-68552-y.
PubMed 39095380