Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro

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

EyeSwift Pro assessment of visual function parameters as measured by psychophysics

Study Overview

• Status: Not yet recruiting
• Conditions: Visual Functions
• Intervention / Treatment: Device: Eyeswift Pro

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 Type: Observational
• Enrollment (Anticipated): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Visual Function; automated vision measured by EyeSwift®Pro-ESP100	Device: Eyeswift Pro; assessment of visual function parameters

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NovaSight

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NS-00921

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No