Clinical trial NCT04175444: Establishing a Normative Database in Pediatric Population of the Head-mounted visuALL Field Analyzer
Official title: Establishing a Normative Database in Pediatric Population of the Head-mounted visuALL Field Analyzer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Field Defect, Peripheral
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population will be healthy children recruited. All ethnicities will be included and both genders.

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

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.

Primary outcomes:
measure: Retinal sensitivity
timeFrame: End of the recruitment phase, average 3 months
measure: Mean retinal sensitivity
timeFrame: End of the recruitment phase, average 3 months
Secondary outcomes:
measure: Frequency of seeing curves
timeFrame: End of the recruitment phase, average 3 months
measure: Ease of device use
timeFrame: End of the recruitment phase, average 3 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sylvia Groth, MD
role: PRINCIPAL_INVESTIGATOR
References: