Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT
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|ClinicalTrials.gov Identifier: NCT03765112|
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Diabetic Retinopathy||Device: Optical coherence tomography angiography||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||175 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT|
|Actual Study Start Date :||September 20, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 31, 2020|
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 [ Time Frame: 6 months ]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.
- Areas of different perfusion density [ Time Frame: 6 months ]Perfusion density of the capillary network will be measured at seven different areas and will be compared within the same patient
- Foveal avascular zone (FAZ) [ Time Frame: 6 months ]Size (area) of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
- Foveal avascular zone (FAZ) [ Time Frame: 6 months ]The circularity of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
- Presence of predominantly peripheral lesions (PPL) [ Time Frame: 6 months ]The presence of PPL (categorical variable yes/no) will be correlated with the perfusion density measured with OCTA
- Retinal layer thickness [ Time Frame: 6 months ]Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA
- 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 [ Time Frame: 18 months ]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,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765112
|Contact: Eduardo Navajas, MD||604 875 email@example.com|
|Contact: Theresa Wiens||604-875-4111 ext firstname.lastname@example.org|
|Eye Care Center||Recruiting|
|Vancouver, Canada, V5Z 3N9|
|Contact: Eduardo Navajas, MD 604 875 5475 email@example.com|
|Contact: Theresa Wiens, MSc 604-875-4111 ext 62544 firstname.lastname@example.org|
|Sub-Investigator: Sonja Karst, MD|