Prospective Clinical Trials to Assess Performance and Saf... | NCT05382676

Studies
Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro

NCT05382676

Sponsor

NovaSight

Status

Unknown status

Last Update Posted

May 19, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Visual Functions

Interventions

Eyeswift Pro

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2022Estimated

Primary Completion Date

Jun 2023Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Apr 25, 2022

First Submission Date that Met QC Criteria

May 16, 2022

First Posted Date

May 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2022

Last Update Posted Date

May 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Label	Type	Description	Intervention Names
Visual Function		automated vision measured by EyeSwift®Pro-ESP100	Device: Eyeswift Pro

Name	Type	Description	Arm Group Labels	Other Names
Eyeswift Pro	Device	assessment of visual function parameters	Visual Function

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
measurement by the EyeSwift®Pro-ESP100	Automated measurement of heterophoria and heterotropia and detection of a deviating eye in the primary eye position	1 day

Secondary Outcomes

Measure	Description	Time Frame
measurement by the EyeSwift®Pro-ESP100	Automated measurement of dichoptic divergence and convergence	1 day
measurement by the EyeSwift®Pro-ESP100	Automated measurement of dynamic resolution acuity

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Probability Sample