Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical App in Comparison to a Standardized Method (TIL-001)

Tilak Healthcare

Status: Completed

Conditions: Near Vision

Treatments: Device: OdySight medical application assessment; Other: Standards vision tests

Study type: Interventional

Funder types: Industry

Identifiers

NCT03457441

2017-A03250-53

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Near visual acuity +1.0 and +0.7 logMAR

Other group

Description:

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

Treatment:

Device: OdySight medical application assessment

Other: Standards vision tests

Near visual acuity +0.6 and +0.3 logMAR

Other group

Description:

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

Treatment:

Device: OdySight medical application assessment

Other: Standards vision tests

Near visual acuity +0.2 and +0.0 logMAR

Other group

Description:

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

Treatment:

Device: OdySight medical application assessment

Other: Standards vision tests