Findings from a recent study published in the American Journal of Ophthalmology indicate positive outcomes following the use of NovaSight’s novel binocular eye-tracking device for treating pediatric patients diagnosed with amblyopia.
Let’s start with NovaSight.
The Tel Aviv, Israel-based medical equipment manufacturer is developing eye-tracking technology and artificial intelligence (AI)-based vision care solutions for pediatric patients.
- Its portfolio consists of three technologies:
- CureSight: A binocular treatment
- EyeSwift: An eye-tracking-based vision diagnostics system
- TrackSight: A software-as-a-service (SaaS)-based vision health monitoring and myopia prevention program
Now this eye-tracking device.
CureSight received 510(k) clearance from the FDA in 2022 as an eye-tracking-based binocular system designed to replace the traditional method of eye patching for pediatric amblyopia.
- What it includes: The system consists of a medical device and red-blue treatment glasses (shipped to a patient’s home and collected following the end of treatment).
Target patients: Children diagnosed with anisometropic amblyopia (no strabismus) between ages 4 and 9, as well as with mild strabismus of up to 5 prism diopters.
And how is the treatment conducted?
Per NovaSight, a patient will watch streamed content of their choosing from their home while simultaneously being monitored under remote supervision by an eye care professional (ECP) and the company’s monitoring center.
The process: Via real-time tracking of both eyes’ gaze position, the system “blurs the center of vision of the dominant eye and provides the lazy eye (amblyopic) with a normal sharp image.”
- What this does: This prompts the visual system to use information originating from the amblyopic eye to then process fine details and, ultimately, improve its acuity and develop stereoacuity while both eyes learn to work in tandem.
Talk about this real-time monitoring.
The system operates via an integrated cloud platform that aggregates all data from the CureSight system, allowing for an ECP to:
- Conduct real-time monitoring of patients’ treatments and progress reports
- Monitoring includes image processing
- Access a patient’s complete vision summary at any time
And how long does treatment take?
Ideally: A minimum of 90 minutes a day, five days a week.
Note: This was the duration used during a previously-conducted, controlled pivotal trial evaluating the system’s efficacy among pediatric amblyopic patients.
- See the data on its long-term (12-week and 1-year posttreatment) vision gains following 4 months of treatment.
How is this different from standard eye patching?
NovaSight has noted that CureSight bypasses the difficulty of traditional patching treatment’s monocular nature by enabling pediatric patients to develop stereoscopic vision.
Even further: The system can be used as an at-home treatment with any streamed digital content.
Alrighty, now let’s talk about this new study.
Published in August, the randomized controlled trial (RCT) evaluated the effectiveness and safety of CureSight treatment versus eye patching in 149 pediatric patients (aged 4 to <9) diagnosed with amblyopia.
The setup:
- Group 1: CureSight binocular treatment (n = 75)
- Treatment duration: 90 minutes/day, 5 days/week for 16 weeks (120 hours)
- Group 2: Patching (n = 74)
- Treatment duration: 2 hours patching/day, 7 days/week (224 hours)
And what was measured?
The primary outcome included mean improvement (from baseline to Week 16) in the VA of the amblyopic eye for both study groups
- Non-inferiority of ≤0.10 logarithm of the minimum angle of resolution (logMAR)
Other outcomes: Changes in both stereoacuity and binocular VA (also baseline to Week 16).
Now these findings.
Based on data from the per protocol (PP) dataset of the trial (n = 54), CureSight was found to be “significantly more effective than patching with greater VA improvements and higher adherence rates compared to those undergoing patching (n = 56),” according to the company.
The numbers:After 16 weeks of treatment, the mean improvement in distance VA in the PP CureSight was 2.8 lines.
- Note: This was 0.53 lines higher than that achieved in the patching group.
Go on …
In regards to the modified intent-to-treat (mITT) CureSight group, median adherence was 94%—notably significantly higher than the patching group (83.9%), NovaSight reported.
So … what does all this mean?
Essentially, the study authors concluded that CureSight—noted as the “binocular, eye-tracking-based amblyopia home treatment,” is “at least as effective as patching.”
And as a whole: “The entire body of CureSight clinical trial evidence — and the most recent findings in particular — demonstrate that this treatment can greatly benefit our patients,” stated Nicholas Sala, DO, of Pediatric Ophthalmology of Erie, Inc., in Erie, Pennsylvania, as well as a clinical investigator of a previous clinical trial of the eye-tracking system.