Visual Field Defect, PeripheralNCT04175444
Establishing a Normative Database in Pediatric Population of the Head-mounted visuALL Field Analyzer
An observational study of Visual Field Defect, Peripheral, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Field Defect, Peripheral
- What is being tested?
- VisuALL Field Analyzer and Humphrey Field Analyzer
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 1 Dec 2022
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Population will be healthy children recruited. All ethnicities will be included and both genders.
Who may be able to join
- No history of intraocular surgery
- Best corrected visual acuity (BVCA) 20/25 or better in each eye
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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).
Read the 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
- Conditions
- Visual Field Defect, Peripheral
- Being tested
- VisuALL Field Analyzer, Humphrey Field Analyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisuALL Field AnalyzerDiagnostic test
Also called visual field testing strategy, head mounted device, Olleyes
Each participant will conduct a visual field test with the visuaALL headset.
Humphrey Field AnalyzerDiagnostic test
Also called standard of care visual field test
Each participant will conduct a standard of care Humphrey Visual Field.
| Study group | Role | What they receive |
|---|---|---|
| Normal Subjects | This is a study of normal subjects to establish a normative database. Receives: Diagnostic Test: VisuALL Field Analyzer; Diagnostic Test: Humphrey Field Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal sensitivity
Retinal sensitivity at each location and compared between the two test strategies
Measured: End of the recruitment phase, average 3 months
Mean retinal sensitivity
Mean retinal sensitivity at each quadrants and each hemifield
Measured: End of the recruitment phase, average 3 months
Secondary outcomes (2)
Frequency of seeing curves
Establish frequency of seeing curves with the head mounted device
Measured: 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.
Measured: End of the recruitment phase, average 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start15 Jun 2020
- Primary completion1 Jul 2020
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Field Defect, PeripheralStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvia L. Groth, MD, Vanderbilt University Medical Center
- Investigators
- Sylvia Groth, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175444
- Sponsor's protocol ID
- 000000001
- Status last verified
- Aug 2023
- First submitted
- 18 Nov 2019
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We are not planning to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Normative Database in Pediatric Population of the Head-mounted visuALL Field Analyzer
- ClinicalTrials.gov ID
- NCT04175444
- Acronym / sponsor ID
- 000000001
- Conditions
- Visual Field Defect, Peripheral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 25 Nov 2019 (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.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Subjects | – | Diagnostic Test: VisuALL Field Analyzer, Diagnostic Test: Humphrey Field AnalyzerThis is a study of normal subjects to establish a normative database. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Population will be healthy children recruited. All ethnicities will be included and both genders.
Key inclusion criteria (2 listed)
- No history of intraocular surgery
- Best corrected visual acuity (BVCA) 20/25 or better in each eye
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| VisuALL Field AnalyzerAlso: visual field testing strategy, head mounted device, OlleyesEach participant will conduct a visual field test with the visuaALL headset. | Diagnostic test | Normal Subjects |
| Humphrey Field AnalyzerAlso: standard of care visual field testEach participant will conduct a standard of care Humphrey Visual Field. | Diagnostic test | Normal Subjects |
Primary outcome
Retinal sensitivity
Time frame: End of the recruitment phase, average 3 months
Retinal sensitivity at each location and compared between the two test strategies
Mean retinal sensitivity
Time frame: End of the recruitment phase, average 3 months
Mean retinal sensitivity at each quadrants and each hemifield
2 secondary outcomes
Frequency of seeing curves
Time frame: End of the recruitment phase, average 3 months
Ease of device use
Time frame: End of the recruitment phase, average 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No. We are not planning to share individual participant data
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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.
Sylvia Groth, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Field Defect, Peripheral, run by Vanderbilt University Medical Center at 1 site in United States.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retinal sensitivity (time frame: End of the recruitment phase, average 3 months). The study lists 2 primary outcomes in all. 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 29 Aug 2023.