Comparison of Smartphone-based Ophthalmoscopy Versus Dilated Ophthalmic Examination for Diabetic and Nondiabetic Eye Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Diabetic retinopathy grading
Study Overview
Brief Summary
A subset of 120 diabetic patients underwent dilated examination and smartphone ophthalmoscopy. The smartphone was equipped with a compact add-on that filtered and delivered the smartphone's LED light coaxially to the camera, allowing a clear and convenient view of the retina.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •type 1 or 2 diabetes
- •ability to provide written informed consent
Exclusion Criteria
- •significant optic media opacities
Outcomes
Primary Outcomes
Diabetic retinopathy grading
Time Frame: The same day as dilated ophthalmic examination
The grading was performed according to the Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy classification. Grade 0: no diabetic retinopathy Grade 1: mild non-proliferative diabetic retinopathy Grade 2: average non-proliferative diabetic retinopathy Grade 3: severe non-proliferative diabetic retinopathy Grade 4: proliferative diabetic retinopathy
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrea Russo
MD, PhD Researcher
Università degli Studi di Brescia