IMOvifa Perimeter Reference Database | NCT05792046

Studies
IMOvifa Perimeter Reference Database

NCT05792046

Sponsor

New View Optometric Center

Status

Completed

Last Update Posted

Sep 29, 2023Actual

Enrollment

376Actual

Phase

Not provided

Conditions

Normal Eyes

Interventions

Visual field

Countries

United States

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Aug 4, 2023Actual

Completion Date

Sep 22, 2023Actual

First Submitted Date

Mar 17, 2023

First Submission Date that Met QC Criteria

Mar 17, 2023

First Posted Date

Mar 30, 2023Actual

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

Sep 27, 2023

Last Update Posted Date

Sep 29, 2023Actual

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

This study will collect data to establish a reference database for the IMOvifa perimeter.

Detailed Description

This study will collect data from a reference population to be used as inputs to the calculation of age corrected significance limits for expected visual function sensitivity to establish reference limits for key output parameters for select test patterns of the IMOvifa perimeter device.

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

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

376Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal		Subjects with normal visual function	Device: Visual field

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Visual field	Device	test for detecting loss in visual function	Normal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reference limit for mean deviation	Visual sensitivity level in decibels	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

22 years of age or older on the date of informed consent
Able to understand the written informed consent and willing to participate
IOP ≤ 21 mmHg (each eye)
BCVA 20/40 or better (each eye)
Both eyes free of ocular conditions that may affect visual function (at doctor's discretion)

Exclusion Criteria:

Unable to tolerate ophthalmic imaging and/or VF testing
History of conditions known to adversely affect visual function (at doctor discretion)
Spherical Equivalent refractive error outside the range from +6 Diopters
Cylindrical refractive error outside the range +2.5 Diopters

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Persons with normal visual function

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Topcon Healthcare Innovation Center		La Jolla	California	92037	United States
New View Optometric Center

Intervention Browse Module

MeSH Terms

ID	Term
D058609	Visual Field Tests

Ancestor Terms

ID	Term
D014787	Vision Tests
D003941	Diagnostic Techniques, Ophthalmological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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Browse Branches

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