Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro

• Conditions: Visual Functions
• Interventions: Device: Eyeswift Pro

• Registration Number: NCT05382676
• Lead Sponsor: NovaSight

Brief Summary

EyeSwift Pro assessment of visual function parameters as measured by psychophysics

Detailed 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).

Study Timeline

• Study First Submitted: 2022-04-25
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-16
• Last Update Submitted: 2022-05-16
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19
• Study Start: 2022-06
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Visual Function	Eyeswift Pro	automated vision measured by EyeSwift®Pro-ESP100

Primary Outcome Measures

Name	Time	Method
measurement by the EyeSwift®Pro-ESP100	1 day	Automated measurement of heterophoria and heterotropia and detection of a deviating eye in the primary eye position

Secondary Outcome Measures

Name	Time	Method
measurement by the EyeSwift®Pro-ESP100	1 day	Automated measurement of extraocular motility