Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: New widefield fundus camera: Retinal imaging performed using the new widefield fundus camera (model: Pristine 5.0)
Intervention2: Nil: Nil
Control Intervention1: Reference standard fund
Sponsors
Remidio Innovative Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Every consecutive participant above 18 years of age who consents to participate in the study and visit the retina clinic
Exclusion criteria
Exclusion criteria: Subjects with significant media opacity that blocks a sufficient view of the fundus, such as advanced cataracts, corneal opacity, vitreous hemorrhage, or other pathology. Subjects with inability to fixate on the target, such as those with nystagmus or amblyopia. Subjects with active eye infection, sudden loss of vision, or who are in the immediate post-operative period (less than two weeks). Subjects who are hypersensitive to light or unable to tolerate fundus imaging. Subjects for whom dilation is contraindicated, such as those with angle closure glaucoma or ocular hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of agreement between Diabetic Retinopathy (DR) stages detected using Pristine 5.0 and Reference Standard.Timepoint: Percentage of agreement between Diabetic Retinopathy (DR) stages detected using Pristine 5.0 and Reference Standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of image quality, including factors such as illumination, focus, fixation, and presence of external artifacts, for images captured using Pristine 5.0 and the Reference Standard.Timepoint: At the time of imaging (baseline visit);Sensitivity, specificity, positive predictive value, and negative predictive value of diabetic retinopathy detection by the Pristine 5.0 system compared to the Reference Standard.Timepoint: At the time of image interpretation (within 1 week of image capture);Sensitivity, specificity, positive predictive value, and negative predictive value of diabetic retinopathy diagnosis by the Pristine 5.0 system and the Reference Standard compared to the ophthalmologist diagnosis.Timepoint: At the time of image interpretation (within 1 week of image capture) | — |
Countries
India
Contacts
Public ContactRanjitha K
Remidio Innovative Solution Pvt Ltd, Bengaluru, India
Outcome results
None listed