Clinical trial NCT05382676: Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro
Official title: Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro for Assessment of Ocular and Visual Functions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Visual Functions
Lead sponsor: NovaSight
Sponsor class: INDUSTRY
First posted: 2022-05-19
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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

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).

Eligibility criteria: 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)

Primary outcomes:
measure: measurement by the EyeSwift®Pro-ESP100
timeFrame: 1 day
Secondary outcomes:
measure: measurement by the EyeSwift®Pro-ESP100
timeFrame: 1 day
measure: measurement by the EyeSwift®Pro-ESP100
timeFrame: 1 day
measure: measurement by the EyeSwift®Pro-ESP100
timeFrame: 1 day
measure: measurement by the EyeSwift®Pro-ESP100
timeFrame: 1 day
measure: measurement by the EyeSwift®Pro-ESP100
timeFrame: 1 day
measure: measurement by the EyeSwift®Pro-ESP100
timeFrame: 1 day
measure: measurement by the EyeSwift®Pro-ESP100
timeFrame: 1 day
measure: measurement by the EyeSwift®Pro-ESP100
timeFrame: 1 day
measure: measurement by the EyeSwift®Pro-ESP100
timeFrame: 1 day
measure: measurement by the EyeSwift®Pro-ESP100
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References: