Vision Therapy for Lazy Eye

Overseen By Jingyun Wang, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York College of Optometry

Disqualifiers: Preterm birth, Neurologic, Developmental, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial investigates how patching and foveation therapy can improve vision in children with amblyopia. Patching involves covering the stronger eye to strengthen the weaker one. Foveation therapy helps the weaker eye focus better. The goal is to see if these treatments can enhance visual clarity and coordination.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Vision Therapy for Lazy Eye treatment?

Research shows that using interactive games and video clips in a novel binocular treatment can improve vision in children with lazy eye, offering a promising alternative to traditional patching, which often has low compliance. Additionally, combining stereoscopic 3D video movies with part-time patching has been effective in older children who do not respond well to patching alone. ^{1 2 3 4 5}

Is vision therapy for lazy eye safe for humans?

Vision therapy for lazy eye, including treatments like eye patching, has been studied in various clinical trials and is generally considered safe for humans. These treatments are commonly used in children and have been part of traditional approaches to improve vision in conditions like amblyopia (lazy eye). ^{1 2 3 6 7}

How is the Vision Therapy for Lazy Eye treatment different from other treatments?

The Vision Therapy for Lazy Eye treatment is unique because it combines after-image and MIT Trainer techniques with traditional eye patching, offering a more interactive and potentially engaging approach compared to standard patching alone, which often suffers from poor compliance. ^{1 2 8 9 10}

Research Team

Jingyun Wang

Principal Investigator

SUNY College of Optmetry

Eligibility Criteria

This trial is for children aged 4-16 with 'lazy eye' due to refractive issues like anisometropia, strabismus, or both. They must have a certain level of reduced vision in the affected eye and not have been born prematurely or have neurological conditions that could affect their eyes.

Inclusion Criteria

Your eyes have a big difference in vision prescription between each other.

I have strabismus with a deviation of 10 or more, or it's well-aligned after surgery.

I am between 4-12 years old and prescribed patching for strabismic amblyopia.

Exclusion Criteria

I was born prematurely, before 32 weeks of pregnancy.

I have a health condition known to affect the eyes.

I have a condition affecting the central part of my retina.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo patching treatment and foveation therapy

12 weeks

1 visit (in-person) at 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• After-image and MIT Trainer
• Eye Patch

Trial Overview The study tests how well different treatments work for lazy eye in kids. Some will use an eye patch while others will try visual exercises like After-image and MIT trainer to improve their vision and how they fixate on objects.

Participant Groups

Group I: foveation therapy Experimental Treatment 1 Intervention

After-image foveation therapy training is 10 mins; MIT training is 5 minutes.

Group II: Patching group Experimental Treatment 1 Intervention

part-time patching following PEDIG guidelines.

Who Is Running the Clinical Trial?

State University of New York College of Optometry

Lead Sponsor

Trials

20

Recruited

1,100+

Findings from Research

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]

In a study involving 107 children aged 3-7 with moderate amblyopia, both adhesive skin patches and over-glasses patches showed similar improvements in visual acuity after 17 weeks, indicating that both methods are effective treatments.

Over-glasses patching is a viable alternative for children who experience discomfort from adhesive patches, as it resulted in less redness of the eye or eyelids, making it a more comfortable option without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between over-glasses patching and adhesive patching for children with moderate amblyopia: a prospective randomized clinical trial. Kim, SJ., Jeon, H., Jung, JH., et al.[2018]

In a study of 41 children under 6 years old who struggled with patching for amblyopia, using elbow splints significantly improved compliance, with 83% of participants adhering to patching guidelines after splint use.

The intervention led to improved visual acuity in 95% of the children, demonstrating that elbow splints can be an effective method to enhance treatment outcomes without causing harm to the fellow eye.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elbow splinting as a method to increase patching compliance in amblyopia therapy. Sabri, K., Easterbrook, B., Wakeman, B., et al.[2018]

A combined treatment of stereoscopic 3D video movies and part-time patching significantly improved visual acuity in amblyopic children compared to patching alone, with a mean improvement of 0.17 logMAR in the combined group versus 0.05 logMAR in the patching group after six weeks.

The combined treatment also enhanced stereoacuity, indicating better binocular function, which was not observed in the patching-only group, highlighting the effectiveness of this innovative approach for children who struggle with traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of binocular therapy as a complementary treatment of part-time patching in older amblyopic children: a randomized clinical trial. Zhu, Q., Zhao, Q., Liang, R., et al.[2023]

In a study of 186 children with intermittent exotropia (IXT), 31.6% showed improvement in their eye alignment and stereoacuity after 1 year of low-dose part-time patching for 2 hours daily.

Factors such as convergence insufficiency, poor distance stereopsis, and larger exotropic deviation at distance were associated with a better response to part-time patching, suggesting it may be an effective non-surgical treatment option for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with the effectiveness of part-time patching for intermittent exotropia in children. Choi, H., Kim, SJ., Jung, J., et al.[2022]

In a study involving 40 children aged 3 to 12 with anisometropic amblyopia, the Occlu-tab device showed a significantly greater improvement in visual acuity compared to conventional eye patches after 8 weeks of treatment.

Both treatment methods improved visual acuity, but the Occlu-tab group had an average improvement of 0.33 logMAR, while the eye patch group improved by only 0.16 logMAR, indicating that the Occlu-tab may be a more effective option for amblyopia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effectiveness of amblyopia treatment with eye-patch and binocular Occlu-tab for the same treatment duration. Handa, T., Thakkar, H., Ramakrishnan, M., et al.[2023]

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 65 children aged 5 to 16 with amblyopia, both active vision therapy (AVT) and conventional patching therapy significantly improved visual acuity in the amblyopic eye, but there was no significant difference in the level of improvement between the two methods.

Active vision therapy was found to be more effective than patching therapy in enhancing stereoacuity, with a significant gain in stereoacuity for the AVT group compared to the patching group, indicating that AVT may offer additional benefits in depth perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of active vision therapy compared to conventional patching therapy on visual acuity and stereoacuity in children with amblyopia. Suwal, R., Dev, MK., Khatri, B., et al.[2023]

A pilot randomized controlled trial involving 60 children aged 3-8 years with moderate to severe amblyopia showed that computer-based activities are generally acceptable and accessible to families as part of amblyopia treatment.

The study found high compliance with prescribed near activities (94% for moderate amblyopes) but lower compliance for severe amblyopes (64%), indicating that while computer games are a promising adjunct to treatment, adherence may vary based on the severity of amblyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribed computer games in addition to occlusion versus standard occlusion treatment for childhood amblyopia: a pilot randomised controlled trial. Tailor, VK., Glaze, S., Khandelwal, P., et al.[2020]

References

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

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

2. 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]

3. Germany pubmed.ncbi.nlm.nih.gov

Comparison between over-glasses patching and adhesive patching for children with moderate amblyopia: a prospective randomized clinical trial. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Elbow splinting as a method to increase patching compliance in amblyopia therapy. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of binocular therapy as a complementary treatment of part-time patching in older amblyopic children: a randomized clinical trial. [2023]

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

Factors associated with the effectiveness of part-time patching for intermittent exotropia in children. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Comparison of the effectiveness of amblyopia treatment with eye-patch and binocular Occlu-tab for the same treatment duration. [2023]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Spain pubmed.ncbi.nlm.nih.gov

Impact of active vision therapy compared to conventional patching therapy on visual acuity and stereoacuity in children with amblyopia. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Prescribed computer games in addition to occlusion versus standard occlusion treatment for childhood amblyopia: a pilot randomised controlled trial. [2020]