Visual FunctionsNCT05382676
Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro
An observational study of Visual Functions, run by NovaSight.
Trial summary
EyeSwift Pro assessment of visual function parameters as measured by psychophysics Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Visual Functions
- What is being tested?
- Eyeswift Pro
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- ≥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)
Show all 10Show fewer
- 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
Who cannot join
- 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)
About this study
Official title: Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro for Assessment of Ocular and Visual Functions
EyeSwift Pro assessment of visual function parameters as measured by psychophysics
Read the 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).
- Conditions
- Visual Functions
- Being tested
- Eyeswift Pro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyeswift ProDevice
assessment of visual function parameters
| Study group | Role | What they receive |
|---|---|---|
| Visual Function | automated vision measured by EyeSwift®Pro-ESP100 Receives: Device: Eyeswift Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement by the EyeSwift®Pro-ESP100
Automated measurement of heterophoria and heterotropia and detection of a deviating eye in the primary eye position
Measured: 1 day
Secondary outcomes (10)
measurement by the EyeSwift®Pro-ESP100
Automated measurement of dichoptic divergence and convergence
Measured: 1 day
measurement by the EyeSwift®Pro-ESP100
Automated measurement of dynamic resolution acuity
Measured: 1 day
measurement by the EyeSwift®Pro-ESP100
Manual measurement of visual acuity
Measured: 1 day
measurement by the EyeSwift®Pro-ESP100
Automated measurement of contrast sensitivity
Measured: 1 day
measurement by the EyeSwift®Pro-ESP100
Presentation of a Worth 4-dot test
Measured: 1 day
measurement by the EyeSwift®Pro-ESP100
Manual testing of color vision impairments
Measured: 1 day
measurement by the EyeSwift®Pro-ESP100
Manual measurement of stereoacuity
Measured: 1 day
measurement by the EyeSwift®Pro-ESP100
Automated analysis of reading patterns
Measured: 1 day
measurement by the EyeSwift®Pro-ESP100
Automated measurement of fixation stability
Measured: 1 day
measurement by the EyeSwift®Pro-ESP100
Automated measurement of extraocular motility
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual FunctionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaSight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382676
- Sponsor's protocol ID
- NS-00921
- Status last verified
- May 2022
- First submitted
- 25 Apr 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro for Assessment of Ocular and Visual Functions
- ClinicalTrials.gov ID
- NCT05382676
- Acronym / sponsor ID
- NS-00921
- Conditions
- Visual Functions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- NovaSightIndustry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual Function | – | Device: Eyeswift Proautomated vision measured by EyeSwift®Pro-ESP100 |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- ≥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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eyeswift Proassessment of visual function parameters | Device | Visual Function |
Primary outcome
measurement by the EyeSwift®Pro-ESP100
Time frame: 1 day
Automated measurement of heterophoria and heterotropia and detection of a deviating eye in the primary eye position
10 secondary outcomes
measurement by the EyeSwift®Pro-ESP100
Time frame: 1 day
measurement by the EyeSwift®Pro-ESP100
Time frame: 1 day
measurement by the EyeSwift®Pro-ESP100
Time frame: 1 day
measurement by the EyeSwift®Pro-ESP100
Time frame: 1 day
measurement by the EyeSwift®Pro-ESP100
Time frame: 1 day
measurement by the EyeSwift®Pro-ESP100
Time frame: 1 day
measurement by the EyeSwift®Pro-ESP100
Time frame: 1 day
measurement by the EyeSwift®Pro-ESP100
Time frame: 1 day
measurement by the EyeSwift®Pro-ESP100
Time frame: 1 day
measurement by the EyeSwift®Pro-ESP100
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Functions, run by NovaSight.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement by the EyeSwift®Pro-ESP100 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.