Establishing a Normative Database in Pediatric Population... | NCT04175444

Studies
Establishing a Normative Database in Pediatric Population of the Head-mounted visuALL Field Analyzer

NCT04175444

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Aug 29, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Visual Field Defect, Peripheral

Interventions

VisuALL Field Analyzer
Humphrey Field Analyzer

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

Aug 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

Jun 15, 2020Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Dec 1, 2022Actual

First Submitted Date

Nov 18, 2019

First Submission Date that Met QC Criteria

Nov 20, 2019

First Posted Date

Nov 25, 2019Actual

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

Aug 28, 2023

Last Update Posted Date

Aug 29, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sylvia L. Groth, MD, Assistant Professor of Ophthalmology, Vanderbilt University Medical CenterPrincipal Investigator

Lead Sponsor

Vanderbilt University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

The goal of this study is to determine reference values of the VisuALL Field Test in pediatric population. Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of different diseases of the visual pathway like glaucoma. Its main goal is to measure the differential light sensitivity at several locations in the central field of vision. Nevertheless, the accuracy of the current devices is limited by several factors such as the inherent inconsistency of the psychophysical test, stressful examinations and frequency of testing.

Several devices have been developed since the advent of the Octopus Perimeter and the Humphrey Field Analyzer (HFA) in an effort to improve the early detection of glaucoma. Several of these visual field test variants are implemented using laptops, iPads, and virtual reality headsets. These modalities bring portability but lack fixation methods, environmental control, and hardware standardization. These deficiencies may limit their wide usage.

The main goal of this study is to develop an initial pediatric reference database of a novel visual field test ecosystem that takes advantage of a Head Mounted Device (HMD).

Detailed Description

This is a cross-sectional observational study. The primary endpoint of the study will be at the end of the recruitment phase.

Participants that qualify for the study will be invited to a clinical site of the Vanderbilt Eye Institute or equivalent testing space and best corrected visual acuity will be checked with standard Snellen Acuity chart.
Once vision is confirmed to meet study requirements, the child will be instructed on how to use the headset.
The test will be generated and participant will complete various testing strategies including suprathreshold, full threshold and individual point testing and possibly other strategies for frequency of seeing curves.
Patient with pathology may be confirmed with formal standard of care visual field testing
Short survey will be administered to inquire on ease of device use
Data will be submitted for analysis

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal Subjects		This is a study of normal subjects to establish a normative database.	Diagnostic Test: VisuALL Field Analyzer Diagnostic Test: Humphrey Field Analyzer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VisuALL Field Analyzer	Diagnostic Test	Each participant will conduct a visual field test with the visuaALL headset.	Normal Subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retinal sensitivity	Retinal sensitivity at each location and compared between the two test strategies	End of the recruitment phase, average 3 months
Mean retinal sensitivity	Mean retinal sensitivity at each quadrants and each hemifield	End of the recruitment phase, average 3 months

Secondary Outcomes

Measure	Description	Time Frame
Frequency of seeing curves	Establish frequency of seeing curves with the head mounted device	End of the recruitment phase, average 3 months
Ease of device use	Patients will be given a short survey asking about ease of device use, 2 questions on 1-5 scale with 1 being the least and 5 being the most.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No history of intraocular surgery
Best corrected visual acuity (BVCA) 20/25 or better in each eye

Exclusion Criteria:

A spherical refraction outside ± 5.0 D and cylinder correction outside 2.0 D.
Intraocular surgery in the study eye
History of systemic condition known to affect visual function.
History of medication known to affect visual function.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Population will be healthy children recruited. All ethnicities will be included and both genders.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sylvia Groth, MD	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37232	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

We are not planning to share individual participant data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided