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

Trial Summary

What is the purpose of this trial?

Patients with visual acuity and ocular characteristics outside the Novasight FDA multi-center study are to perform the same Curesight procedures- including M\&S EVA or eETDRS patched acuity, stereo and then utilize the Curesight device 1.5 hours per day, 6 days per week over 3-6 months to determine treatment efficacy. An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial T. Wygnanski-Jaffe, B. J. Kushner, A. Moshkovitz, M. Belkin, O. Yehezkel and G. CureSight Pivotal Trial Ophthalmology 2023 Vol. 130 Issue 3 Pages 274-285

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 data supports the effectiveness of the CureSight treatment for lazy eye?

The CureSight treatment, which is a novel binocular eye-tracking-based home therapy, has been compared to traditional patching in a clinical trial and is being studied for its potential to improve vision in children with amblyopia (lazy eye). Similar treatments using 3D technology and interactive games have shown positive results in improving vision over a short period. ^{1 2 3 4 5}

Is CureSight safe for treating lazy eye?

The clinical trial for CureSight, a home treatment for lazy eye, does not report any specific safety concerns, suggesting it is generally safe for use in humans. ^{3 6 7 8 9}

How is the CureSight treatment for lazy eye different from other treatments?

CureSight is unique because it uses a binocular eye-tracking-based home treatment, which is different from the traditional method of patching the stronger eye to force the weaker eye to work harder. ^{3 10 11 12 13}

Research Team

Robert W Arnold, MD

Principal Investigator

Alaska Blind Child Discovery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Outcomes of esotropia surgery in Saudi Arabia: An audit from a single center. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of vergence/accommodative therapy for accommodative dysfunction in children with convergence insufficiency. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial. [2023]

4. England 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Variability of strabismus surgery for acquired esotropia. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Limits on improving the positive predictive value of the Welch Allyn SureSight for preschool vision screening. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Performance of the Plusoptix vision screener for the detection of amblyopia risk factors in children. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of SureSight autorefractor and plusoptiX A09 photoscreener for vision screening in rural Honduras. [2016]

10. Australia pubmed.ncbi.nlm.nih.gov

Amblyopia--or lazy eye. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

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

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Method of prevention and treating the accommodation cramp and progressive myopia in children]. [2006]