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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06150495
Other study ID # IRB no. 2021-06-029
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 259
Est. completion date December 31, 2025
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility 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.

Study Design


Locations

Country Name City State
Korea, Republic of Dongguk University Ilsan Hospital Goyang-si Republic Of Korea

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The foveal avascular zone (FAZ) area (mm^2) FAZ was defined as the avascular area in the foveal center. Upon initial registration and through study completion, an average of 1 year
Primary central foveal retinal thickness (um) and macular ganglion cell-inner plexiform layer (GC-IPL) thickness (um) Retinal layer thickness were calculated automatically using the bundled software Upon initial registration and through study completion, an average of 1 year
Primary Retinal vessel density (VD, %) The VD (%) was calculated using the following formula: VD (%) = vascular area (pixel) / (total area - FAZ area) (pixel) × 100. Upon initial registration and through study completion, an average of 1 year
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