Status:
UNKNOWN
Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro
Lead Sponsor:
NovaSight
Conditions:
Visual Functions
Eligibility:
All Genders
6+ years
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 ...
Eligibility Criteria
Inclusion
- ≥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
- 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)
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05382676
Start Date
June 1 2022
End Date
June 1 2023
Last Update
May 19 2022
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