Study of a device for detecting diabetic eye disease
Not Applicable
- Conditions
- Diabetic retinopathyEye Diseases
- Registration Number
- ISRCTN11684778
- Lead Sponsor
- Fraunhofer Portugal Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 578
Inclusion Criteria
1. Diabetes mellitus diagnosis
2. 18-90 years old
Exclusion Criteria
1. Blindness
2. Strabismus
3. Retinal detachment
4. Blepharospasm
5. No autonomy to remain seated
6. Sensitivity to light due to medication, recent photodynamic therapy, or other reason
7. Pregnant or breastfeeding women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of EyeFundusScope for diabetic retinopathy screening, measured using sensitivity, specificity, predictive values and likelihood ratios at the time of retinal image acquisition
- Secondary Outcome Measures
Name Time Method