Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro

Study Overview
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Brief Summary
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EyeSwift Pro assessment of visual function parameters as measured by psychophysics

Detailed Description
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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).

Official Title
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Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro for Assessment of Ocular and Visual Functions

Conditions
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Visual Functions

Intervention / Treatment
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* Device: Eyeswift Pro


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Visual Function<br>automated vision measured by EyeSwift®Pro-ESP100 | Device: Eyeswift Pro<br>* assessment of visual function parameters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement by the EyeSwift®Pro-ESP100 | Automated measurement of heterophoria and heterotropia and detection of a deviating eye in the primary eye position | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement by the EyeSwift®Pro-ESP100 | Automated measurement of dichoptic divergence and convergence | 1 day | 
| measurement by the EyeSwift®Pro-ESP100 | Automated measurement of dynamic resolution acuity | 1 day | 
| measurement by the EyeSwift®Pro-ESP100 | Manual measurement of visual acuity | 1 day | 
| measurement by the EyeSwift®Pro-ESP100 | Automated measurement of contrast sensitivity | 1 day | 
| measurement by the EyeSwift®Pro-ESP100 | Presentation of a Worth 4-dot test | 1 day | 
| measurement by the EyeSwift®Pro-ESP100 | Manual testing of color vision impairments | 1 day | 
| measurement by the EyeSwift®Pro-ESP100 | Manual measurement of stereoacuity | 1 day | 
| measurement by the EyeSwift®Pro-ESP100 | Automated analysis of reading patterns | 1 day | 
| measurement by the EyeSwift®Pro-ESP100 | Automated measurement of fixation stability | 1 day | 
| measurement by the EyeSwift®Pro-ESP100 | Automated measurement of extraocular motility | 1 day |