Diabetic Retinopathy Grading Clinical Trial
Official title:
Comparison of Smartphone-based Ophthalmoscopy Versus Dilated Ophthalmic Examination for Diabetic and Nondiabetic Eye Disease
| Verified date | June 2014 |
| Source | Università degli Studi di Brescia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - type 1 or 2 diabetes - ability to provide written informed consent Exclusion Criteria: - significant optic media opacities |
Intervention Model: Single Group Assignment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Spedali Civili di Brescia | Brescia | BS |
| Lead Sponsor | Collaborator |
|---|---|
| Università degli Studi di Brescia | Luisa Delcassi, Nausica Ghilardi |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diabetic retinopathy grading | 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 |
The same day as dilated ophthalmic examination | No |