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

NCT07232225 | Not Yet Recruiting

• 1 other identifier: OCT DME
• Study Type: observational
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline ( single assessment at the time of enrollment )

Secondary Outcomes (1)

• Correlation between OCT changes and duration of diabetes/HbA1c level

  Baseline ( single assessment at the time of enrollment )

Study Arms (2)

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

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

Interventions

Spectral Domain OCT Imaging 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.

Asymptomatic Diabetic Patients; Healthy Control Subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 39232012 RESULT

• Kim 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.

  PMID: 40465771 RESULT

• Aldakhil 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.

  PMID: 40002602 RESULT

• Kalaw 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.

  PMID: 39191790 RESULT

• Endo 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.

  PMID: 33542264 RESULT

• Shah 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.

  PMID: 39095380 RESULT

Central Study Contacts

Abanoub Rafaat Rizkallah, MBBCh

CONTACT

+201222505178; Abanoub.15235476@med.aun.edu.eg

Wael Mohamed Soliman, MD

CONTACT

+201065566530; waelsoliman73@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician / Master's Candidate, Ophthalmology Department

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11