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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OdySight vs Standardized methods | All patients perform Visual Acuity testing through OdySight and according to standard practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Software as medical device | Other | At home measurements of visual acuity through a mobile app |
|
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence between OdySight and standardized methods - Near Visual Acuity | 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity | ETDRS visual acuity at a 4-meter distance at clinic and near visual acuity evaluated with ODYSIGHT at home. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Near Visual Acuity - Subgroups analysis | 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 | 2 months |
| Near Visual Acuity variability |
Inclusion Criteria:
General inclusion criteria:
Age ≥ 18 years, all genders
Affiliated to or beneficiary of the French health care system
Signed/written informed consent
Already user of Odysight on a compatible smartphone/tablet
Patients willing and able to comply with all study and follow-up procedure
Ophthalmic inclusion criterion:
Baseline binocular visual acuity with habitual correction ≥ 20/63 (3/10) AND with at least an eye ≥ 20/200 (1/10).
Exclusion Criteria:
General exclusion criteria:
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Subjects with a near visual acuity between 0.0 and 1.0 logMAR in at least one eye, and binocular VA equal to or better than 0.5 logMAR are targeted for this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Ophtalmologique Rabelais | Lyon | 69002 | France | |||
| Institut Ophtalmologique de l'Ouest Clinique Jules Verne |
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| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D008269 | Macular Edema |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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To assess variability of measurements with a smartphone-based evaluation of NVA with Odysight at home vs at clinic |
| 2 months |
| Vision changes tracking | To evaluate ability of the VA application module to track vision change over time as compared to standardized methods. | 2 months |
| Compliance to OdySight | To evaluate compliance of daily use among time. | 2 months |
| Nantes |
| 44000 |
| France |
| Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts | Paris | Île-de-France Region | 75012 | France |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |