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

Tilak Healthcare120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

120

Conditions

Near Vision

Interventions

Standards vision testsOTHER

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

OdySight medical application assessmentDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

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).

Time frame: 1 day ( During evaluation visit)

Secondary Outcomes

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)

Time frame: 1 day ( During evaluation visit)

Data from ClinicalTrials.gov

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