Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
259 participants
OBSERVATIONAL
2019-01-01
2025-12-31
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy control
The controls included patients without DM who presented for regular ophthalmic examination.
No interventions assigned to this group
intensive control (IC) group
The mean HbA1c level was calculated during the 12 months prior to the OCT and OCTA. Based on the mean HbA1c level, T2DM patients were divided into intensive control (IC; mean HbA1c ≤ 7.0%) and moderate control (MC; mean HbA1c \> 7.0%) groups
No interventions assigned to this group
moderate control (MC) group
The mean HbA1c level was calculated during the 12 months prior to the OCT and OCTA. Based on the mean HbA1c level, T2DM patients were divided into intensive control (IC; mean HbA1c ≤ 7.0%) and moderate control (MC; mean HbA1c \> 7.0%) groups
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 neurodegenerative diseases, such as Parkinson's disease and dementia.
30 Years
70 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Locations
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Dongguk University Ilsan Hospital
Goyang-si, Republic of Korea, South Korea
Countries
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Other Identifiers
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IRB no. 2021-06-029
Identifier Type: -
Identifier Source: org_study_id