Optical Coherence Tomography Angiography Biomarkers in Diabetic Nephropathy Patients in Thailand: A Diabetic Eye and Kidney Diseases Study

Completed

• Conditions: Diabetic mellitusDiabetic nephropathyDiabetic retinopathyMicroalbuminuriaMacroalbuminuria; diabetes mellitus; diabetic retinopathy; diabetic nephropathy; microalbuminuria; macroalbuminuria; optical coherence tomography angiography; OCTA; vessel density; intercapillary area

• Registration Number: TCTR20210308001
• Lead Sponsor: Ratchadapiseksompotch Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-08
• Study Completion: 2022-03-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

1.Participants aged 18-70 years with a diagnosis of type 2 diabetes mellitus according to diagnostic criteria by the American Diabetes Association
2.History of 24-urine albumin and creatinine testing within 3 months prior the recruitment
3.For no DN group, participants with 24-hour urine albumin <30 mg
4.For early DN group, participant with 24-hour urine albumin 30-300 mg
5.For late DN group, participants with 24-hour urine albumin >300 mg
6.Absence of retinal anomaly other than diabetic retinopathy

Exclusion Criteria

1.History of ocular trauma or surgery other than uncomplicated cataract surgery
2.History corneal disorders, strabismus, nystagmus, uveitis, glaucoma, optic nerve abnormalities, neurological disorders or other abnormalities affecting the visual pathway
3.History of retinal laser treatment or intravitreal anti-vascular growth factor (anti-VEGF) treatment
4.Presence of diabetic macular edema or tractional retinal detachment
5.Media opacities preventing reliable retinal imaging
6.Active urinary tract infection
7.Suspected of any non-diabetic renal diseases
8.End-stage kidney disease requiring dialysis or kidney transplantation
9.Participants who could not cooperate adequately for the OCTA examination

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vessel density At the beginning of the study Optical coherence tomography angiography and calculated with automated software

Secondary Outcome Measures

Name	Time	Method
Intercapillary area At the beginning of the study Optical coherence tomography angiography and calculated with automated software,FAZ area At the beginning of the study Optical coherence tomography angiography and calculated with automated software,Fractal dimension At the beginning of the study Optical coherence tomography angiography and calculated with automated software,Subfoveal choroidal thickness At the beginning of the study Optical coherence tomography angiography and calculated with automated software