Near Vision
Conditions
Brief summary
This study evaluates the level of agreement between visual parameters tested using OdySight, a mobile application, and standards in office methods.
Interventions
OTHERStandards vision tests
Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application
DEVICEOdySight medical application assessment
Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application
Sponsors
Tilak Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years * Able to correctly distinguish the body laterality (left and right) * Able to recognize alphabet letters and read French * Affiliated to or beneficiary of the French health care system * Signed/written informed consent * Subject presenting a level of visual acuity of one of his eyes that fits to one of the pre-set cohort (visual acuity between +1.0 and +0.7 logMAR, between +0.6 and +0.3 logMAR or between +0.2 and 0.0 logMAR); the two eyes can be included in two different cohorts.
Exclusion criteria
* Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria. * Pregnant and breastfeeding women. * Subject not considered by the investigator or designee to correctly use OdySight modules after the training session
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Near visual acuity assessment with OdySight versus with near visual acuity chart | 1 day ( During evaluation visit) | To assess the equivalence between a smartphone based evaluation of near visual acuity with ODYSIGHT (NVA module) and a standardized method (Sloan ETDRS near vision letter chart). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Near visual acuity assessment with OdySight versus with ETDRS chart | 1 day ( During evaluation visit) | To assess the relation between the ETDRS visual acuity at a 4-meter distance and near visual acuity evaluated with ODYSIGHT (NVA module) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Contrast sensitivity assessment with OdySight versus with Pelli-Robson | 1 day ( During evaluation visit) | To compare the smartphone based evaluation of the contrast sensitivity with ODYSIGHT (contrast sensitivity module) and a standardized method (Pelli-Robson chart) |
| Scotoma/metamorphopsia detection with OdySight versus with standard Amsler grid | 1 day ( During evaluation visit) | To compare the smartphone based evaluation of the Amsler Grid with ODYSIGHT (Amsler grid module) and standardized methods (paper Amsler Grid) |
| Global functional disorders assessment with Odysight versus with OCT | 1 day ( During evaluation visit) | To compare functional disorder(s) detected or measured by ODYSIGHT application with anatomical data (OCT: Optical coherence tomography) |
Countries
France
Outcome results
None listed