Status:
UNKNOWN
Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT
Lead Sponsor:
University of British Columbia
Conditions:
Diabetes Mellitus
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery
- Inability to obtain fundus images of sufficient quality to be analyzed and graded
Key Trial Info
Start Date :
September 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT03765112
Start Date
September 20 2018
End Date
March 31 2023
Last Update
October 1 2021
Active Locations (1)
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1
Eye Care Center
Vancouver, Canada, V5Z 3N9