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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05382676
Enrollment
500
Registered
2022-05-19
Start date
2022-06-30
Completion date
2023-06-30
Last updated
2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Functions

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).

Interventions

DEVICEEyeswift Pro

assessment of visual function parameters

Sponsors

NovaSight
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
measurement by the EyeSwift®Pro-ESP1001 dayAutomated measurement of heterophoria and heterotropia and detection of a deviating eye in the primary eye position

Secondary

MeasureTime frameDescription
measurement by the EyeSwift®Pro-ESP1001 dayAutomated measurement of dichoptic divergence and convergence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026