Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- University of British Columbia
- Enrollment
- 175
- Locations
- 1
- Primary Endpoint
- Perfusion density
- Last Updated
- 4 years ago
Overview
Brief Summary
This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls.
Detailed Description
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.
Investigators
Eduardo Navajas
Principal Investigator
University of British Columbia
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 Participants can have 1 or 2 study eyes
- •Patient Group:
- •Diabetes mellitus type 1 or 2
- •Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR
Exclusion Criteria
- •Substantial media opacities that would preclude successful imaging
- •Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye
- •Structural damage to the center of macula in the study eye
- •History of prior panretinal photocoagulation
- •History of treatment with intravitreal agents over the prior 6 months
- •Macular edema involving the central subfield
- •Prior history of vitrectomy
- •Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques
- •Substantial non-diabetic intraocular pathology in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies
- •Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0, or history of corneal transplantation in the study eye
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Areas of different perfusion density(6 months)
- Foveal avascular zone (FAZ)(6 months)
- Presence of predominantly peripheral lesions (PPL)(6 months)
- Retinal layer thickness(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(18 months)