Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro
NCT ID: NCT05382676
Last Updated: 2022-05-19
Study Results
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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UNKNOWN
500 participants
OBSERVATIONAL
2022-06-30
2023-06-30
Brief Summary
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Detailed Description
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* 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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Study Groups
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Visual Function
automated vision measured by EyeSwift®Pro-ESP100
Eyeswift Pro
assessment of visual function parameters
Interventions
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Eyeswift Pro
assessment of visual function parameters
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
6 Years
ALL
No
Sponsors
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NovaSight
INDUSTRY
Responsible Party
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Other Identifiers
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NS-00921
Identifier Type: -
Identifier Source: org_study_id
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