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

Not Applicable

Completed

• Conditions: Near Vision

• Registration Number: NCT03457441
• Lead Sponsor: Tilak Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-07
• Study Start: 2018-03-20
• Status Verified: 2018-07
• Primary Completion: 2018-07-24
• Study Completion: 2018-07-24
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts; 🇫🇷 Paris, Ile-de-France, France