CureSight for Lazy Eye

(ABCDCS Trial)

Overseen By Robert W Arnold, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Alaska Blind Child Discovery

Disqualifiers: Lack of brain and eye capacity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a home treatment for individuals with amblyopia, commonly known as "lazy eye." Participants will use the CureSight device to improve vision by wearing it for 1.5 hours a day, six days a week, over three to six months. The trial seeks individuals with amblyopia who do not fit the usual categories of previous studies. It is not suitable for those without home WiFi or with conditions that prevent vision improvement. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for amblyopia in the comfort of one's home.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the CureSight device is safe for treating amblyopia?

Research has shown that the CureSight treatment for amblyopia, or "lazy eye," is safe for patients. Earlier studies found no serious side effects. Any minor side effects were temporary and resolved on their own. The FDA has approved this treatment for children aged 4 to under 9 years, indicating it has been carefully tested for safety in that age group. Although this trial includes older participants, existing research provides a good indication of its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for lazy eye, which often involve patching the stronger eye or using atropine drops to blur it, SureSight offers a novel approach by using a digital therapeutic method. This innovative treatment works through a specialized device that provides visual stimuli to improve the weaker eye. Researchers are excited because SureSight has the potential to be a non-invasive, user-friendly alternative that could enhance compliance and effectiveness, especially for those who fall outside the typical FDA treatment ranges for amblyopia.

What evidence suggests that the CureSight device is effective for treating amblyopia?

Research has shown that the CureSight system, which participants in this trial will use, effectively treats amblyopia, also known as lazy eye. Studies have found that patients using CureSight improved their vision sharpness significantly more than those using only glasses. Specifically, patients experienced an improvement of 1.8 logMAR with CureSight, compared to just 0.8 logMAR with glasses alone. Additionally, 93% of parents reported satisfaction with the treatment results. The CureSight device employs a new method with eye-tracking technology to help train the eyes, making it a promising option for those who may not benefit from traditional treatments. ^{1 4 6 7 8}

Who Is on the Research Team?

Robert W Arnold, MD

Principal Investigator

Alaska Blind Child Discovery

Are You a Good Fit for This Trial?

This trial is for individuals with amblyopia, commonly known as 'lazy eye,' who are not part of the Novasight FDA study and have the potential to improve their vision. Participants must have home WiFi access and should not have any neurological or ocular conditions that would prevent visual improvement.

Inclusion Criteria

amblyopia

Exclusion Criteria

lack of home WiFi

My vision cannot be improved with treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CureSight treatment for amblyopia, using an eye-tracking-based dichoptic system for 90 minutes per day, 5 days a week

16 weeks

Home-based treatment with regular monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including visual acuity and stereopsis assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SureSight

Trial Overview

The trial is testing a device called Curesight, which patients use at home for 1.5 hours daily, six days a week over 3-6 months. The treatment involves eye-tracking technology aimed at improving visual acuity and stereo vision in people with lazy eye.

How Is the Trial Designed?

Group I: Amblyopia therapy with Curesight outside FDA limited ranges Experimental Treatment 1 Intervention

Severity of amblyopia and age range outside FDA study

SureSight is already approved in United States, European Union, China for the following indications:

Approved in United States as CureSight for:

• Improvement in visual acuity and stereoacuity in amblyopia patients, aged 4-<9 years, associated with anisometropia and/or with mild strabismus

Approved in European Union as CureSight for:

• Improvement in visual acuity and stereoacuity in amblyopia patients, aged 4-<9 years, associated with anisometropia and/or with mild strabismus

Approved in China as CureSight for:

• Improvement in visual acuity and stereoacuity in amblyopia patients, aged 4-<9 years, associated with anisometropia and/or with mild strabismus

Who Is Running the Clinical Trial?

Alaska Blind Child Discovery

Lead Sponsor

Trials

10

Recruited

6,200+

Published Research Related to This Trial

Amblyopia, or 'lazy eye,' affects about 2-3% of the population and is most effectively treated during infancy or early childhood.

The primary treatment involves patching the stronger eye to force the weaker eye to develop better vision, as simply addressing the underlying cause is not sufficient for improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amblyopia: etiology, diagnosis, and treatment. American Academy of Ophthalmology. [2004]

A new treatment method for children with accommodation cramp and progressive myopia involves alternating their focus between a close TV screen and a far one, which has shown promising results.

In a study of 65 children, this method improved their relative accommodation and significantly reduced the progression of myopia to only 0.045 diopters over a year, compared to 0.5 diopters in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Method of prevention and treating the accommodation cramp and progressive myopia in children]. Shatalov, OA., Chentsova, OB.[2006]

Traditionally, patching the good eye has been the primary treatment for amblyopia (lazy eye) for over a century.

Recent research indicates that spending time in complete darkness may lead to a rapid improvement in vision for individuals with amblyopia, suggesting a new potential treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amblyopia: out of the dark, into the light. Sengpiel, F.[2021]

In a study of 99 patients who underwent surgery for esotropia, 70.7% achieved excellent outcomes shortly after surgery, although this number decreased to 57.6% at the final follow-up, indicating that while initial results are promising, long-term success may vary.

Risk factors for poorer surgical outcomes included simultaneous vertical muscle surgery and superior oblique muscle palsy, highlighting the importance of considering these factors during preoperative counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of esotropia surgery in Saudi Arabia: An audit from a single center. Sulayem, LM., Bin-Khathlan, AA.[2022]

Office-based vergence/accommodative therapy significantly improved accommodative amplitude by an average of 8.6 diopters in children with convergence insufficiency, compared to a 5.2 diopter improvement in the placebo group, indicating a meaningful therapeutic effect.

The therapy also enhanced accommodative facility, with an average increase of 13.5 cycles per minute in the treatment group versus 7.6 in the placebo group, and a higher percentage of participants achieving normal function (85% vs. 49%), demonstrating its efficacy in addressing these visual dysfunctions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of vergence/accommodative therapy for accommodative dysfunction in children with convergence insufficiency. Chen, AM., Roberts, TL., Cotter, SA., et al.[2023]

A randomized clinical trial involving 75 children aged 4 to 8 years with amblyopia is testing the effectiveness of a novel treatment called I-BiT™, which uses 3D technology and computer games, compared to traditional methods.

The trial will assess changes in visual acuity over 6 weeks of treatment, aiming to improve compliance and outcomes in amblyopia treatment, which traditionally suffers from low adherence to patching therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation and development of a novel binocular treatment (I-BiT™) system using video clips and interactive games to improve vision in children with amblyopia ('lazy eye'): study protocol for a randomised controlled trial. Foss, AJ., Gregson, RM., MacKeith, D., et al.[2021]

In a study of 216 Honduran children, both the SureSight autorefractor and the plusoptiX A09 photoscreener were effective in detecting amblyopia risk factors, with the plusoptiX showing higher specificity (80%) compared to SureSight (71%).

Both screening devices demonstrated high sensitivity (89%) for identifying amblyopia risk factors, making them reliable options for vision screening in rural settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of SureSight autorefractor and plusoptiX A09 photoscreener for vision screening in rural Honduras. Silbert, DI., Matta, NS., Ely, AL.[2016]

The Welch Allyn SureSight vision screening tool was used effectively on over 15,000 preschool children, achieving reliable results in more than 99% of cases, indicating its high efficacy for large-scale screenings.

Adjusting referral criteria improved the positive predictive value (PPV) of the screenings, reaching about 64% at a 4% referral rate, but further adjustments did not enhance PPV and risked reducing sensitivity, highlighting a balance needed in screening practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limits on improving the positive predictive value of the Welch Allyn SureSight for preschool vision screening. Silverstein, E., Lorenz, S., Emmons, K., et al.[2019]

Patient compliance with amblyopia treatments, such as eye patching and atropine drops, is often lower than prescribed, which negatively impacts visual acuity outcomes.

The implementation of the Inside Out Care online platform has successfully improved monitoring of patient compliance with amblyopia therapies and enhanced communication between doctors and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment compliance in amblyopia: A mini-review and description of a novel online platform for compliance tracking. Le, T., Örge, F.[2022]

The novel binocular eye-tracking treatment, CureSight, demonstrated noninferior visual acuity improvement compared to traditional patching in children with amblyopia, with both groups showing significant gains in visual function after 16 weeks of treatment.

CureSight treatment had higher adherence rates (91%) compared to patching (83%), suggesting it may be a more acceptable alternative for young children undergoing amblyopia treatment, with no serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial. Wygnanski-Jaffe, T., Kushner, BJ., Moshkovitz, A., et al.[2023]

Amblyopia, commonly known as lazy eye, is a condition where the eye appears healthy but has poor vision that does not improve with corrective lenses, and it can be hereditary.

The paper discusses various predisposing factors for amblyopia and evaluates current assessment methods and treatment effectiveness, highlighting the importance of early detection and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amblyopia--or lazy eye. Fraser, H.[2006]

The Plusoptix vision screener effectively detects amblyopia risk factors in children, with a high sensitivity of 98% and a referral rate of 67% for those identified with risk factors among 109 patients examined.

Modifying the manufacturer's referral criteria improved the device's specificity and positive predictive value to 88% and 90%, respectively, while maintaining the same high sensitivity, making it a more reliable tool for large-scale vision screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the Plusoptix vision screener for the detection of amblyopia risk factors in children. Matta, NS., Singman, EL., Silbert, DI.[2022]

A mathematical model was created to estimate the success rate of the first surgery for correcting acquired esotropia in children, predicting success rates between 72% and 96% based on various surgical and measurement assumptions.

The study highlights that even with skilled surgical techniques, a certain percentage of surgical failures is expected in the treatment of strabismus, emphasizing the inherent challenges in achieving perfect outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability of strabismus surgery for acquired esotropia. Mims, JL., Treff, G., Wood, RC.[2019]

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Aetna adds CureSight as medically necessary for amblyopia

Findings from a recent study published in the American Journal of Ophthalmology indicate positive outcomes following the use of NovaSight's ...

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aao.org

aao.org/young-ophthalmologists/yo-info/article/understanding-digital-treatments-for-amblyopia

Understanding Digital Treatments for Amblyopia

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optometrytimes.com/view/novasight-s-curesight-device-proves-effective-in-amblyopia-treatment-study-finds

NovaSight's CureSight device proves effective in ...

A questionnaire given to study participant parents found that 93% were satisfied with the CureSight system as a treatment for amblyopia, with 91 ...

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clinicaltrials.gov/study/NCT04785690

Study Details | NCT04785690 | CURESIGHT BINOCULAR ...

Passing a dedicated 10 min in-clinic performance ability test to assure suitable eye tracking performance (validity of eye tracking data >90% and successful ...

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K221375 - Lee Kramm - accessdata.fda.gov

The CureSight™ system is indicated for improvement in visual acuity and stereo acuity in amblyopia patients, aged 4-<9 years, associated with ...

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Eye Tracking Based Remote Digital Amblyopia Treatment

CureSight is an FDA cleared eye tracking based system designed for remote binocular vision treatment in pediatric patients.

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CureSightŘE TUNİ - FREQUENTLY USED

CureSight™ is an FDA cleared eye tracking based system designed for remote binocular vision treatment in pediatric patients (aged 4 to <9 years) suffering from ...