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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to improve vision in children with amblyopia, commonly known as lazy eye. Researchers focus on the relationship between different eye movements and eye sensitivity. Participants will either use an eye patch part-time or try a combination of after-image and MIT Trainer exercises, a type of vision therapy. This trial suits children with noticeable vision differences between their eyes due to conditions like misaligned eyes or differences in prescription strength. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could lead to new treatment methods for amblyopia.

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 prior data suggests that these vision therapy methods are safe for children with amblyopia?

Research shows that both treatments in this trial—the after-image and MIT Trainer, and the eye patch—are well-tolerated by children with amblyopia, also known as lazy eye. Studies indicate these methods are commonly used in vision therapy.

The after-image and MIT Trainer are traditional methods to help improve vision in conditions like amblyopia. Although specific data on side effects for these treatments is lacking, they are generally accepted in the field.

Eye patches are also widely used to treat amblyopia. They are designed to be gentle and comfortable, using soft, breathable materials that are often hypoallergenic, reducing the likelihood of allergic reactions. This suggests they are safe for use, even on sensitive skin.

Overall, both treatments are considered safe based on their common use and design. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the vision therapy techniques being tested for lazy eye because they offer innovative approaches compared to traditional treatments like eye patching or corrective lenses. The after-image and MIT Trainer methods focus on engaging the brain's visual processing by using specialized exercises, potentially enhancing eye coordination and visual acuity more effectively. Unlike standard practices that mainly rely on covering the stronger eye to force the weaker one to work harder, these new techniques incorporate brief, targeted training sessions that could accelerate improvement. This approach might offer a more engaging and less intrusive experience for patients, making it a promising alternative.

What evidence suggests that this trial's treatments could be effective for lazy eye?

Research shows that using an eye patch, which participants in this trial may receive, can help treat moderate to severe amblyopia, also known as lazy eye, in children. Studies indicate that covering the stronger eye for two hours each day can significantly improve vision. Another study found that electronic glasses, which function like a digital patch, are just as effective as traditional cloth patches.

For participants in this trial receiving treatments like after-image and MIT Trainer, research has shown promise for improving vision clarity in people with amblyopia. In one study, after several training sessions, all participants experienced better vision, with some seeing major improvements. These treatments help by training the brain to use the weaker eye more effectively. ^{1 6 7 8 9}

Who Is on the Research Team?

Jingyun Wang

Principal Investigator

SUNY College of Optmetry

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-amblyopia-2023-5430d

Vision Therapy for Lazy Eye 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- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4257702/

Interventions for Stimulus Deprivation Amblyopia [Review] The mainstay of treatment is patching of the better-seeing eye but regimes vary, treatment is difficult to execute and results are often disappointing.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6389748/

A new counterintuitive training for adult amblyopia - PMC After six brief (2 h) training sessions, visual acuity improved in all 10 patients (0.15 ± 0.02 LogMar), and six of them also recovered ...

4. researchgate.net researchgate.net/publication/297950558_Effect_of_afterimage_therapy_in_treatment_children's_eccentric_fixation_amblyopia

Effect of afterimage therapy in treatment children's ... RESULTS: The percentages of cured eyes in age group of 4 to 5 years, 6 to7 years, and above 8 years were 44%, 30% and 7% respectively. The percentages of cured ...

5. latinamericanjo.com latinamericanjo.com/long-term-efficacy-of-perceptual-learning-therapy-in-amblyopia-a-5-year-follow-up-study/

Long-term efficacy of perceptual learning therapy in ... PLT significantly improves visual acuity in amblyopic patients and provides sustained benefits over a 5-year follow-up period.

6. aao.org aao.org/Assets/c345150e-a392-48ac-b707-8d5db695c695/638447356123330000/amblyopia-ppp-2024-update-2-28-24-pdf

Amblyopia Preferred Practice Pattern Following treatment of amblyopia caused by strabismus, anisometropia, or both, continued monitoring is necessary and additional treatment, if ...

7. jamanetwork.com jamanetwork.com/journals/jamaophthalmology/fullarticle/2832963

Cone Density Changes After Repeated Low-Level Red ... The exclusion criteria included strabismus, amblyopia, cataracts, retinopathy, optic neuropathy, and previous ophthalmic surgery.

8. researchgate.net researchgate.net/publication/317716214_Therapy_for_Amblyopia_A_newer_perspective

(PDF) Therapy for Amblyopia: A newer perspective The conventional treatments for amblyopia include refractive correction, occlusion, and atropine penalization.

9. nature.com nature.com/articles/s41598-022-20191-x

Rehabilitative strategies after filtering procedure in glaucoma ... amblyopia. In our previously presented studies we have underlined that in rehabilitation strategies of low-vision patients ...