OCT-Based Screening for Early Retinal Changes in Asymptomatic Diabetic Patients (NCT07232225) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
OCT-Based Screening for Early Retinal Changes in Asymptomatic Diabetic Patients
112 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of retinal thickness parameters between diabetic patients and healthy controls
Timeframe: Baseline ( single assessment at the time of enrollment )