Visual Impairment
Conditions
Keywords
Visual acuity, Digital therapeutics, Medical software, ETDRS, Macular Edema, Age-related Macular Degeneration
Brief summary
OdySight is a mobile application allowing self-testing of visual parameters including near visual acuity and communication of the data to an online dashboard to patient's doctors. TIL-002 post-market clinical trial objective is to evaluate the near visual acuity at home, measured with OdySight application in comparison to the standardized methods. The clinical trial is intended to prove that OdySight can provide relevant data and participate in the remote monitoring of subject vision.
Interventions
OTHERSoftware as medical device
At home measurements of visual acuity through a mobile app
Sponsors
Tilak Healthcare
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
General inclusion criteria: 1. Age ≥ 18 years, all genders 2. Affiliated to or beneficiary of the French health care system 3. Signed/written informed consent 4. Already user of Odysight on a compatible smartphone/tablet 5. Patients willing and able to comply with all study and follow-up procedure Ophthalmic inclusion criterion: 6. Baseline binocular visual acuity with habitual correction ≥ 20/63 (3/10) AND with at least an eye ≥ 20/200 (1/10).
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Equivalence between OdySight and standardized methods - Near Visual Acuity | 2 months | To assess the equivalence between a smartphone based evaluation of near visual acuity with ODYSIGHT at home and standardized methods (Sloan ETDRS near vision letter chart and Landolt C near vision chart) performed in clinic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity | 2 months | ETDRS visual acuity at a 4-meter distance at clinic and near visual acuity evaluated with ODYSIGHT at home. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Near Visual Acuity - Subgroups analysis | 2 months | To assess the equivalence between a smartphone based evaluation of near visual acuity with ODYSIGHT at home and with standardized methods in specific subgroups defined by visual acuity and by pathology |
| Near Visual Acuity variability | 2 months | To assess variability of measurements with a smartphone-based evaluation of NVA with Odysight at home vs at clinic |
| Vision changes tracking | 2 months | To evaluate ability of the VA application module to track vision change over time as compared to standardized methods. |
| Compliance to OdySight | 2 months | To evaluate compliance of daily use among time. |
Countries
France
Outcome results
None listed