Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro

NovaSight

Status: Unknown

Conditions: Visual Functions

Treatments: Device: Eyeswift Pro

Study type: Observational

Funder types: Industry

Identifiers

NCT05382676

NS-00921

Details and patient eligibility

About

EyeSwift Pro assessment of visual function parameters as measured by psychophysics

Full description

The following assessments and procedures will be carried out in this trial:

• Baseline assessments will include the following: age, gender, ethnicity, race, education, clinical ocular diagnosis, and general health and use of any concomitant medications.
• Visual and ocular assessment will include unitary testing methods, using the EyeSwift Pro system and the reference method (if applicable).

Enrollment: 500 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥4 years
• Have visual acuity better than 6/60
• Diagnosed as having either Orthophoria or/and Heterophoria or/and Orthotropia or/and heterotopia (group A only)
• Normal vision or visual impermeant (group C and E only)
• Normal or deficient vergence (group D only)
• Normal or deficient reading disabilities (group F only)
• 8 years and older or third grade (group F only)
• Subject in general good health and able, as per investigator decision, to comply with study visits and protocol procedures
• Signed and dated informed consent form
• Parent and participant understand and are willing to comply with

Exclusion criteria

• Anophthalmic
• Photosensitive epilepsy or susceptible to epileptic seizures
• Pre-existing concomitant pathology such as congenital cataracts or glaucoma (not including group E)
• Severe developmental delay that would interfere with testing (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded
• Extraocular muscle (EOM) paralysis (groups A and B only)
• Nystagmus
• Any ocular pathology or anomalies which can interfere with eye-tracking
• Any ocular pathology or anomalies (i.e., age-related macular degeneration (AMD), diabetic retinopathy etc.) (relevant for groups A-F, group E can include such anomalies)

Trial design

500 participants in 1 patient group

Visual Function

Description:

automated vision measured by EyeSwift®Pro-ESP100

Treatment:

Device: Eyeswift Pro