Glycemic Control and Retinal Microvascular Changes (NCT06150495) | Clinical Trial Compass
UnknownNot Applicable
Glycemic Control and Retinal Microvascular Changes
South Korea259 participantsStarted 2019-01-01
Plain-language summary
The goal of this prospective, observational study is to compare in the association of glycemic control and retinal microvascular changes in patients with type 2 diabetes mellitus (T2DM) without diabetic retinopathy (DR).
The main question it aims to answer are:
• Do degenerative changes in retinal microvasculature or nerves depend on glycemic control even before diabetic retinopathy is detected?
Participants will receive an annual routine comprehensive examination including ultra-widefield fundus photography, spectral domain optical coherence tomography (OCT), and swept-source optical coherence tomography angiography (OCTA).
Who can participate
Age range
30 Years – 70 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:
* The study included 30-70-year-old patients with T2DM without known DR at baseline who underwent regular screening for DR at the department of ophthalmology.
* Who underwent regular checkups for DR between January 2019 and August 2022 at Dongguk University Ilsan Hospital.
* The controls included patients without DM who presented for regular ophthalmic examination.
Exclusion Criteria:
* patients with a history of retinal or choroidal diseases (i.e., age-related macular degeneration, retinal vein occlusion, uveitis, retinal detachment, and central serous chorioretinopathy), glaucoma, or optic neuropathy
* patients with neurodegenerative diseases, such as Parkinson's disease and dementia.
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
The foveal avascular zone (FAZ) area (mm^2)
Timeframe: Upon initial registration and through study completion, an average of 1 year
2
central foveal retinal thickness (um) and macular ganglion cell-inner plexiform layer (GC-IPL) thickness (um)
Timeframe: Upon initial registration and through study completion, an average of 1 year
3
Retinal vessel density (VD, %)
Timeframe: Upon initial registration and through study completion, an average of 1 year