Post-market Evaluation of OdySight App to Monitor Near Visual Acuity at Home (TIL002)

Study Overview
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Brief Summary
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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.

Official Title
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Post-market Study for At-home Evaluation of Near Visual Acuity With OdySight, a Smartphone Based Medical Application in Comparison to a Standardized Method (TIL002)

Conditions
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Visual Impairment

Intervention / Treatment
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* Other: Software as medical device


Participation Criteria
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Eligibility Criteria
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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: Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria. Any planned surgery likely to modify patient refraction during the study (cataract surgery for example) Subject not considered by the investigator or designee to correctly use ODYSIGHT modules Subject unable to recognize alphabet letters or unable to correctly distinguish body laterality Not French speaking patient Epileptic users

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OdySight vs Standardized methods<br>All patients perform Visual Acuity testing through OdySight and according to standard practice | Other: Software as medical device<br>* At home measurements of visual acuity through a mobile app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual acuity, Digital therapeutics, Medical software, ETDRS, Macular Edema, Age-related Macular Degeneration