Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCTA | Experimental | Patients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical coherence tomography angiography | Device | Multiple scans of the retina will be recorded to evaluate microvascular changes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Foveal avascular zone (FAZ) |
Not provided
Inclusion Criteria:
Patient Group:
Exclusion Criteria:
Substantial media opacities that would preclude successful imaging
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo Navajas, MD | Contact | 604 875 5475 | edunavajas@gmail.com | |
| Theresa Wiens | Contact | 604-875-4111 | 62544 | twiens@eyecarecentre.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Care Center | Recruiting | Vancouver | V5Z 3N9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32392316 | Derived | Karst SG, Heisler M, Lo J, Schuck N, Safari A, V Sarunic M, Maberley DAL, Navajas EV. Evaluating Signs of Microangiopathy Secondary to Diabetes in Different Areas of the Retina with Swept Source OCTA. Invest Ophthalmol Vis Sci. 2020 May 11;61(5):8. doi: 10.1167/iovs.61.5.8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Size (area) of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
| 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. | 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 | 6 months |
| Retinal layer thickness | Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA | 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, | 18 months |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |