Published in Research

Study finds comparable data for Olleyes VisuALL VRP in SAP for pediatrics

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5 min read

A new study published in the Journal of the American Association for Pediatric Ophthalmology and Strabismus (APPOS) examined the use of Olleyes’ VisuALL virtual reality platform (VRP) against the conventional Humphrey visual field (HVF) when performing standard automated perimetry (SAP) in pediatric patients with glaucoma.

Let’s start with Olleyes.

Founded in 2018 as a privately-held medical software company, Olleyes, Inc. is focused on developing diagnostic technology for in-office and at-home evaluation of glaucoma, diabetic retinopathy (DR), and age-related macular degeneration (AMD).

And the VisuALL?

The VisuALL VRP is a novel, head-mounted visual perimetry device (available in two models) and VR VF assessment system that enables simultaneous binocularity during VF testing and gamification of the testing strategy.

The comprehensive tests include (but are not limited to):

  • Visual acuity (VA)
  • Color vision
  • Pupillometry
  • Extraocular motility

Talk about its other features.

The portable system includes:

  • A headset with ultra high definition resolution (4K HD)
  • Fully integrated suite of diagnostic tools for comprehensive testing (see above)
  • Proprietary testing algorithm designed to reduce fixation loss to zero
    • Animated and gamified testing with child-friendly methods
  • Virtual assistant (named “Annie”) equipped to help users in 20+ languages

Gotcha. Now talk about the study.

  • Approved by the Institutional Review Board of the Duke University Medical Center, the prospective observational study enrolled  children < 21 years of age with known or suspected glaucoma.

Patients were identified as having glaucoma based on the Childhood Glaucoma Research Network classification system with 2 or more of the following criteria:

  • Intraocular pressure (IOP) >21 mmHg
  • Progressive myopia
  • Corneal enlargement or Haab striae
  • Characteristic optic nerve cupping or cup asymmetry
  • Reproducible field defects on prior visual field testing.

Glaucoma suspects were identified as having one (but not more) of the previous criteria.

What was assessed?

Study participants were enrolled from January to November 2022—underwent a comprehensive eye exam that included:

  • IOP measurement
  • Refraction
  • Stereoacuity testing

Further, participants underwent VF testing via the Humphrey Field Analyzer (HFA) (HVF 24-2 SITA Fast protocol [size 3 stimulus]) followed by the game-based VisuALL VRF 24-2 (size 3 stimulus) evaluating foveal sensitivity, individual sensitivities at all points, and global indices (mean deviation [MD], pattern standard deviation [PSD]), according to the study.

And the findings?

A total of 77 eyes (38 participants; average age = 14.1 ± 3.6 years) were included in the final data set.

Additionally, three participants (5 eyes) completed the VRF (VisuALL) but not the HVF 24-2 (HFA).

Give me some numbers.

Investigators observed a significant correlation in the mean sensitivity of both VisuALL and conventional HFA for both groups:

  • Healthy: R = 0.5
  • Glaucoma: R = 0.8

Expert input on this?

Although there is a longstanding assumption that HVF has been the gold standard for this study, the investigators found that there are indications in which the VRF can perform as well as HVF.

When evaluating the subset of eyes with optical coherence tomography (OCT) retinal nerve fiber layer (RNFL) measurements of <70 μm (n = 25)—in whom visual field defects were expected—VRF was able to identify defects in 100%, while HVF identified defects in only 92% of study participants.

What was the average test time?

  • VisuALL: 365 ± 108 seconds (P < 0.001)
  • HFA: 238 ± 63 seconds (P < 0.001)

And this all means…

These findings demonstrate that VisuALL is comparable to conventional HVF SAP and—of the utmost significance—is well-tolerated in a pediatric glaucoma population, according to the investigators.

So what was the significance of this study?

Per the authors, this was the first study of its kind to utilize VRF in this pediatric population, adding “our findings add evidence to a growing body of literature in adults about the potential for VR and portable laptop fields to be transformative in-office as well as home testing.”

And for the future?

They recommended that further studies are needed to determine the following:

  • Evaluate the use of VRF for home use in pediatric patients
  • Assess the learning effect of field tests in the pediatric glaucoma population
  • Identify whether a game-based VRF is clinically superior to a non-game-based VRF

Final conclusion?

The authors concluded that VRF testing such as VisuALL offers “the advantage of not requiring a dedicated testing area or examination room,” as well as a more comfortable option for certain patients.

Thus, it could potentially provide a “suitable substitute” for clinical practices that do not have easy access to a standard HVF device.

*Featured image courtesy of Olleyes.

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