Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro

NCT05382676 | Unknown

• 1 other identifier: NS-00921
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

EyeSwift Pro assessment of visual function parameters as measured by psychophysics

Conditions

Visual Functions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• measurement by the EyeSwift®Pro-ESP100

  1 day

• measurement by the EyeSwift®Pro-ESP100

  1 day

• measurement by the EyeSwift®Pro-ESP100

  1 day

• measurement by the EyeSwift®Pro-ESP100

  1 day

• measurement by the EyeSwift®Pro-ESP100

  1 day

Study Arms (1)

Visual Function

automated vision measured by EyeSwift®Pro-ESP100

Device: Eyeswift Pro

Interventions

Eyeswift Pro DEVICE

assessment of visual function parameters

Visual Function

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The EyeSwift® Pro-ESP100 is indicated for use in patients aged 3 years and above who are responsive to taking direction and who can pay attention for the duration of the required tests/ protocols

You may qualify if:

• ≥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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NovaSight: lead

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 19, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 19, 2022

Record last verified: 2022-05