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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT-Based Screening for Early Retinal Changes in Asymptomatic Diabetic Patients
- ClinicalTrials.gov ID
- NCT07232225
- Acronym / sponsor ID
- DREAM-OCT / OCT DME
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Diabetic Patients | – | Diagnostic Test: Spectral Domain OCT ImagingPatients 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) |
| Healthy Control Subjects | – | Diagnostic Test: Spectral Domain OCT ImagingAge-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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectral Domain OCT ImagingNon-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. | Diagnostic test | Asymptomatic Diabetic Patients, Healthy Control Subjects |
Primary outcome
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).
1 secondary outcome
Correlation between OCT changes and duration of diabetes/HbA1c level
Time frame: Baseline ( single assessment at the time of enrollment )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Results publication: PubMed 39232012Gu 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.
- Results publication: PubMed 40465771Kim 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.
- Results publication: PubMed 40002602Aldakhil 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.
- Results publication: PubMed 39191790Kalaw 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.
- Results publication: PubMed 33542264Endo 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.
- Results publication: PubMed 39095380Shah 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.
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
RecruitingPhase 2
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Enrolling by invitationPhase 3
Suprachoroidal Bevacizumab Versus Intravitreal Bevacizumab in Diabetic Macular Edema
Diabetic Macular Edema (DME)
RecruitingPhase 4
Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
Diabetic Retinal Disease
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
Diabetic Retinopathy, Macular Edema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abanoub Rafaat Rizkallah, MBBCh (+201222505178, Abanoub.15235476@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of retinal thickness parameters between diabetic patients and healthy controls (time frame: Baseline ( single assessment at the time of enrollment )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07232225, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.