An interventional study of Optical coherence tomography angiography in Diabetes Mellitus and Diabetic Retinopathy, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by University of British Columbia · Not applicable, Interventional, and Diagnostic
This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls.
The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the most prevalent complication of DM and a leading cause of visual impairment due to closure of capillaries. High-resolution imaging techniques of the retina and its supplying vascular networks can allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In this study capillary changes of patients with different severity levels of diabetic retinopathy will be investigated with non-invasive imaging technology to better understand the process of disease progression.
Imaging will be done with Optical Coherence tomography (OCT) angiography as well as spectral domain OCT and ultra wide-field imaging.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's planned enrollment of 175 is above the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Patient Group:
Exclusion Criteria:
Substantial media opacities that would preclude successful imaging
Patients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging.
Device: Optical coherence tomography angiography
Multiple scans of the retina will be recorded to evaluate microvascular changes.
Perfusion density
The density of perfused capillaries (metric variable) measured with optical coherence tomography angiography (OCTA) will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Time frame: 6 months
Areas of different perfusion density
Perfusion density of the capillary network will be measured at seven different areas and will be compared within the same patient
Time frame: 6 months
Foveal avascular zone (FAZ)
Size (area) of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Time frame: 6 months
Foveal avascular zone (FAZ)
The circularity of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Time frame: 6 months
Presence of predominantly peripheral lesions (PPL)
The presence of PPL (categorical variable yes/no) will be correlated with the perfusion density measured with OCTA
Time frame: 6 months
Retinal layer thickness
Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA
Time frame: 6 months
Change in perfusion density in patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR over the follow up of one year
Patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR will be followed over one year. Perfusion density will be measured at each timepoint and followed over the year,
Time frame: 18 months
Plan to share: No
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University of British Columbia