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FDA Cleared Eye Tracking Based Amblyopia Treatment

Amblyopia (Lazy-eye) affects 3% of all population and puts the patients at risk for eventual vision loss.
Gold Standard treatment for lazy eye is placing a patch over the strong eye – an old-fashioned solution which suffers from very low compliance.
With the CureSight™ binocular treatment, children develop stereoscopic vision, which is difficult to be achieved with the monocular nature of the traditional patching treatment.

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FDA Cleared Eye Tracking Based Amblyopia Treatment

Amblyopia (Lazy-eye) affects 3% of all population and puts the patients at risk for eventual vision loss. Gold Standard treatment for lazy eye is placing a patch over the strong eye – an old-fashioned solution which suffers from very low compliance With the CureSight™ binocular treatment, children develop stereoscopic vision, which is difficult to be achieved with the monocular nature of the traditional patching treatment.

Cloud Monitored Treatment

Supported by an integrated cloud platform that processes data from the CureSight™ system, the eye care provider receives a comprehensive patient vision summary. Progress reports and real-time monitoring of the child's treatment are easily accessible.
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Binocular treatment

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Eye-Tracking based real time image processing

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Remote monitoring

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Home treatment

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Proven in a large trial against gold standard patching

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Any streamed content

Pivotal Study Results - CureSight non-inferior to patching

Multicenter, randomized, controlled pivotal study of CureSight against the gold standard patching

Stereo Acuity - Significant improvement in both groups

Significant improvement (p value<0.05) in visual acuity and stereoacuity from baseline to week 16

No serious adverse events

103 children aged 4-9

6 medical centers


Visual Acuity – Amblyopic Eye

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satisfaction

Parents that are likely or very likely to choose the CureSight over patching

adherence

As objectively measured by CureSight’s eye tracking system

2-line or more improvement

2 line 1.1

FAQ

The CureSight device is FDA cleared following a multi-center pivotal trial which was conducted in 6 medical centers, including Sheba medical center – ranked as one of the top 10 hospitals globally. The trial, which included 103 patients, compared the improvement in visual outcomes achieved by CureSight versus the eye patch. This is the first ever pivotal trial where a digital device was shown to be non-inferior to eye patching for amblyopia treatment in children. On top of demonstrating non-inferiority to patching, the CureSight treatment group achieved a larger improvement in visual acuity. The study showed that 79% of the CureSight patients achieved a 2-line of visual acuity improvement compared to only 61% in the patching group at week 16.

In addition, a significant stereoacuity improvement was observed in the CureSight patients. No serious adverse events were observed, and all non-serious adverse events were transient and self-limiting.

The study also exhibited 93% adherence to the CureSight treatment as was accurately measured by the eye-tracking system of the device, as well as 95% likelihood of the parents to choose CureSight over patching.

The CureSight is a digital eye tracking based lazy eye treatment using a special device and red-blue treatment glasses. The device will be shipped to your home by the CureSight Monitoring Center and will be collected from your house at the end of the treatment.

The treatment is carried out while the child watches any streamed content of choice at in the comfort of his home, under the remote supervision of an eye care provider and a dedicated Monitoring Center.

By tracking the gaze position of both eyes in real-time, the CureSight system blurs the center of vision of the dominant eye and provides the lazy eye with a normal sharp image. This stimulates the visual system to use the information coming from the lazy eye to process the fine details, improving its acuity and developing stereoacuity as the eyes learn to work together.

Feedback is provided to eye care providers and to the clinical team at the CureSight Monitoring Center via a dedicated web portal including real-time remote compliance monitoring.

During the treatment period, the Monitoring Center tracks the patient’s compliance and makes sure the treatment is going according to the treatment regimen. The Monitoring Center provides remote training and technical support and will call the patient’s guardians to encourage compliance in case required.

If your child is diagnosed with anisometropic amblyopia (no strabismus) and aged between 4-<9, the CureSight treatment may be suitable for him. Patients with mild strabismus of up to 5 prism diopters are also within the CureSight’s intended use population.

 

In order to find out whether your child is suitable for the treatment, reach out to your eye care provider.  

The CureSight system was proven to be safe and effective treatment in a large clinical study. Nonetheless, the CureSight treatment is not intended for children with history of light-induced epilepsy.

The Gold Standard treatment for lazy eye is placing a patch over the dominant eye – an archaic and uncomfortable solution which suffers from very low compliance and negative social stigma.
In addition, since patching is a monocular treatment (treats the amblyopic eye separately from the dominant eye) children who are treated with the patch will not develop stereoacuity (depth perception-3D vision) in many cases.
The CureSight system is a fun and engaging digital system designed to replace traditional eye patching for amblyopia treatment.
CureSight is a binocular treatment (treats both eyes to work simultaneously), thus achieving both improvement in visual acuity and stereoacuity. In addition, the daily treatment time with CureSight is shorter than patching and has much higher compliance. Finally, due to the support of the CureSight Monitoring Center, your child will get the full support throughout the entire treatment period while your treating physician will have remote control over the process.

The treatment with the CureSight systems requires a minimum of 90 minutes per day, 5 days a week. The duration of the treatment will be instructed by the referring physician – CureSight pivotal study was conducted for 4 months, and the safety and efficacy results were analyzed following this treatment period.

The red-blue treatment glasses are required during the CureSight treatment in order to present separate and individual streamed content to each eye.
The glasses enable to manipulate the information presented to the dominant eye without effecting the content of the amblyopic eye.
The red lens is positioned in front of the dominant eye and the blue one in front of the amblyopic eye. The red-blue glasses are discarded by the end of your child’s treatment and are not required to be sent back to the CureSight Monitoring Center.

The CureSight unique algorithm allows watching any streamed content of choice such as: Netflix, YouTube, Disney, TV programs, movies, zoom, social media and more. In addition, the CureSight device has parental control for parents who wish to prevent access to specific streamed services from their treated child. Any paid content (such as Netflix, Disney+, etc.) will need a valid license as with any other internet browser.

To find out more about the treatment and its availability, please consult your child’s eye care provider. Patients will need a referral from their eye care provider to be enrolled in the CureSight Amblyopic Treatment Program. A list of referring physicians is constantly updating on NovaSight’s website, please visit https://nova-sight.com/curesight-us-referral-program/

The CureSight treatment is potentially reimbursable in the US through three unique CPT codes assigned by the American Medical Association (AMA), in which 2 of them are set to bill initial CureSight setup and monthly progress monitoring. The benefit and eligibility verification as well as billing is done by the Monitoring Center.
However, coverage may vary between insurance companies and plans and should be assessed with your provider prior to beginning the treatment.

CureSight is currently not covered by medical insurance program outside of the US.

CureSight Monitoring Center is the epicenter for patients and physicians, supported by a team of technical and patient engagement specialists. The services provided by the Monitoring Center include compliance monitoring, troubleshooting, and technical support. Directed by practicing ophthalmologists and supported by a team of certified ophthalmic professionals and patient engagement specialists, CureSight’s Monitoring Center provides comprehensive, beginning-to-end physician and patient education, engagement, and support.

The CureSight system is indicated for improvement in visual acuity and stereo acuity in amblyopia patients, aged 4 – <9 years, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional.
CureSight is intended for both previously treated and untreated patients and is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the anaglyph glasses during CureSight treatment.

Once a child is diagnosed with amblyopia and prescribed with the CureSight treatment, the eye care provider creates a ‘new patient’ via the dedicated web portal. The new patient account is also going to be used as the patient’s prescription.
After receiving the prescription, the Monitoring Center makes a benefit and eligibility verification and once approved – the device is shipped to the patient’s home via FedEx.
Upon arrival – the Monitoring Center guides the patient’s guardians how to set up and operate the device and will also track the patient’s compliance to the treatment.
The treatment is carried out according to the recommended eye care provider’s protocol and the device’s instructions of use. Supported by an integrated web portal which processes data from the CureSight system, the eye care provider receives a comprehensive patient progress reports and real-time monitoring of the child’s treatment’s compliance throughout the entire treatment time

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CureSight Amblyopia Treatment: Replace Patching with 3D Glasses and Netflix For the Win!

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