NovaSight announced the release of 1-year follow-up outcomes for CureSight, an at-home amblyopia treatment, published in the American Journal of Ophthalmology.
Refresh me on NovaSight.
Launched in 2016, the Tel Aviv, Israel-based company is a medical equipment manufacturer specializing in vision care solutions based on artificial intelligence (AI) and eye-tracking technologies.
Its target patient base: pediatric vision care
Its products:
- CureSight (more on that in a moment)
- EyeSwift
- Eye tracking-based vision diagnostics system
- Includes original and EyeSwift Pro device, designed to provide fast, accurate, and objective measurements of multiple visual performances + identify various visual system impairments
- TrackSight
- Software-based vision health monitoring and myopia prevention
- Uses computer monitors’ embedded webcam to perform eye-tracking on digital devices
Now talk about CureSight.
Cleared by the FDA as an eye tracking-based amblyopia treatment, the CureSight binocular system is designed to replace the traditional method of an eye patch.
The result: CureSight helps pediatric patients develop stereoscopic vision—”which is difficult to be achieved with the monocular nature of traditional patching treatment,” according to the company.
How does it work?
Per NovaSight, an integrated cloud platform processes all data from the CureSight system, enabling an eyecare professional (ECP) to gain access to a comprehensive patient vision summary at any time.
This includes real-time monitoring of patients’ treatments (such as image processing) as well as progress reports.
The key differentiator for this: CureSight can be used as an at-home treatment with any streamed digital content.
Gotcha. So what did this follow-up trial analyze?
The prospective, multicenter, nonrandomized, observational study examined the long-term outcomes of the treatment group in a previous non-inferiority randomized controlled trial (RCT) that examined CureSight as a treatment for pediatric amblyopia.
The study’s positive data was reported in 2022.
I’m not familiar with this RCT … give me a recap.
The single-masked (examiner only), controlled pivotal trial (NCT05185076) enrolled 103 pediatric participants (aged 4 to under 9) diagnosed with amblyopia. Patients were randomized into two groups:
- Experimental (CureSight)
- Participants (n = 43) watched CureSight-based treatment for 90 minutes per day, 5 days a week for 16 weeks
- Daily sessions must have been completed in a single 90-minute session or two shorter sessions equaling 90 minutes per day
- Comparator (Patching occlusive deprivation)
- Participants wore an adhesive patch over the dominant eye for 2 hours per day, 7 days per week for 16 weeks
- Daily 2 hours of patching must have been completed in a single 2-hour session or two shorter sessions equaling 2 hours per day
- Note: The exact number of participants in this group is unclear.
- Daily 2 hours of patching must have been completed in a single 2-hour session or two shorter sessions equaling 2 hours per day
- Participants wore an adhesive patch over the dominant eye for 2 hours per day, 7 days per week for 16 weeks
What was measured and found?
Measured: Best-corrected visual acuity (BCVA) over the 16-week study period. The findings: Participants in the CureSight treatment group showed significant improvement in both VA and stereoacuity via the use of CureSight vs eye patching. Significance: The study was the first large-scale RCT where a digital device was demonstrated to be non-inferior to eye patching for amblyopia.
I’m up-to-date! Now talk about this new follow-up study.
In this long-term follow-up study, investigators re-examined 38 of the 43 CureSight-treated pediatric participants from the original RCT at 12 weeks post-treatment. Note: These patients did not receive additional amblyopia treatment.
Later on, researchers then evaluated 27 of the 38 participants at 1-year post-treatment.
And the findings?
- 12 weeks post-treatment
- Amblyopic eye VA improvement was maintained vs baseline (0.27±0.14 logMAR, p<0.0001)
- No statistically significant change compared to end-of-treatment visit (p > 0.05)
- 1-year post-treatment
- Partial reduction in amblyopia eye VA gain of 0.085±0.1 logMAR vs end-of-treatment (p = 0.001)
- Statistically significant (p < 0.0001) residual gain of 0.20±0.14 logMAR vs baseline
How substantial was amblyopia recurrence?
Defined as “a worsening of ≥2 logMAR levels compared with end-of-treatment” amblyopia recurrence was noted in 5.3% of patients at 12 weeks post-treatment, and 20.4% of patients at 1 year post-treatment.
Any commonalities between the two time periods?
At both 12 weeks and 1 year, stereoacuity and binocular gains were maintained compared to baseline (p < 0.0001), “with no change vs end-of-treatment (p > 0.05),” according to the study authors.
Limitations?
Per the investigators:
- Treatment mandate for subject to be seated (in lieu of moving around (in front of a digital screen)
- Streamed digital content was customizable by parents, enabling the potential for educational content (homework) that wouldn’t be added to the participant’s overall screen time.
Take home.
The authors concluded that, overall, the CureSight system was found to significantly improve vision in amblyopic pediatric patients at not just a short treatment time, but at least 1-year post-treatment.