Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical App in Comparison to a Standardized Method

Study Overview
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Brief Summary
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This study evaluates the level of agreement between visual parameters tested using OdySight, a mobile application, and standards in office methods.

Official Title
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Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical Application in Comparison to a Standardized Method

Conditions
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Near Vision

Intervention / Treatment
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* Other: Standards vision tests
* Device: OdySight medical application assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Near visual acuity +1.0 and +0.7 logMAR<br>Subjects with near visual acuity between +1.0 and +0.7 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application | Other: Standards vision tests<br>* 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<br>Device: OdySight medical application assessment<br>* 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<br>|
| Other: Near visual acuity +0.6 and +0.3 logMAR<br>Subjects with near visual acuity between +0.6 and +0.3 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application | Other: Standards vision tests<br>* 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<br>Device: OdySight medical application assessment<br>* 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<br>|
| Other: Near visual acuity +0.2 and +0.0 logMAR<br>Subjects with near visual acuity between +0.2 and +0.0 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application | Other: Standards vision tests<br>* 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<br>Device: OdySight medical application assessment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near visual acuity assessment with OdySight versus with near visual acuity chart | 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). | 1 day ( During evaluation visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near visual acuity assessment with OdySight versus with ETDRS chart | To assess the relation between the ETDRS visual acuity at a 4-meter distance and near visual acuity evaluated with ODYSIGHT (NVA module) | 1 day ( During evaluation visit) |