Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro

NCT ID: NCT05382676

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-06-30

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).

Conditions

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Visual Functions

Study Groups

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Visual Function

automated vision measured by EyeSwift®Pro-ESP100

Eyeswift Pro

Intervention Type DEVICE

assessment of visual function parameters

Interventions

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Eyeswift Pro

assessment of visual function parameters

Intervention Type DEVICE

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)
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NovaSight

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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NS-00921

Identifier Type: -

Identifier Source: org_study_id

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