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

Tilak Healthcare58 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Visual Impairment

Interventions

Software as medical deviceOTHER

At home measurements of visual acuity through a mobile app

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 exclusion criteria: 1. Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria. 2. Any planned surgery likely to modify patient refraction during the study (cataract surgery for example) 3. Subject not considered by the investigator or designee to correctly use ODYSIGHT modules 4. Subject unable to recognize alphabet letters or unable to correctly distinguish body laterality 5. Not French speaking patient 6. Epileptic users

Locations (3)

Centre Ophtalmologique Rabelais

Lyon, France

Institut Ophtalmologique de l'Ouest Clinique Jules Verne

Nantes, France

Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

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.

Time frame: 2 months

Secondary Outcomes

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.

Time frame: 2 months

Data from ClinicalTrials.gov

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