What is the mechanism of action of this treatment?

The most common treatments for Lazy Eye (Amblyopia) include patching the stronger eye, atropine drops, and vision therapy. Patching forces the weaker eye to work harder, thereby improving its visual acuity and alignment. Atropine drops blur vision in the stronger eye, similarly encouraging use of the weaker eye. Vision therapy involves exercises that enhance eye coordination and focus. Optical Coherence Tomography (OCT) is used to measure eccentric fixation, fixation eye movement, and macular sensitivity, providing detailed insights into the structural and functional improvements in the amblyopic eye. These treatments are crucial as they help in the development of normal vision by promoting the use of the weaker eye, thereby preventing long-term visual impairment.

What side effects are associated with this type of intervention?

Common treatments for Lazy Eye (Amblyopia) include patching the stronger eye, atropine eye drops, and vision therapy exercises. Patching can cause skin irritation and discomfort around the eye. Atropine drops may lead to light sensitivity, eye irritation, and blurred vision. Vision therapy exercises generally have minimal side effects but can sometimes cause eye strain or headaches. Treatments involving Optical Coherence Tomography (OCT) are primarily diagnostic and non-invasive, with minimal risk, but may cause temporary discomfort or light sensitivity during the procedure.

What prior FDA approvals exist?

Currently, the primary FDA-approved treatments for Lazy Eye (Amblyopia) include corrective eyewear, patching of the stronger eye, and atropine eye drops to blur vision in the stronger eye, thereby forcing the weaker eye to work harder. These treatments aim to improve visual acuity in the affected eye. While Optical Coherence Tomography (OCT) is a valuable diagnostic tool for assessing retinal structure and function, it is not a treatment modality. OCT can help in understanding the underlying mechanisms of amblyopia and monitoring treatment progress, but it does not replace conventional therapeutic approaches.

What other types of research exist?

Promising novel alternatives to OCT for treating lazy eye (amblyopia) in 2024 include Adaptive Optics Scanning Laser Ophthalmoscopy (AO-SLO) and Functional Magnetic Resonance Imaging (fMRI). AO-SLO provides high-resolution imaging of retinal structures and can track eye movements with high precision, while fMRI can assess brain activity related to visual processing, offering insights into neural adaptations in amblyopia.

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Vision Therapy for Lazy Eye

N/A

Recruiting

Led By Jingyun Wang

Research Sponsored by State University of New York College of Optometry

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children with best-corrected visual acuity (BCVA) of 20/40 (equivalent to 0.3 logMAR) or worse in the amblyopic eye (ranging from 20/40 to 20/400), and interocular difference of BCVA was at least two logMAR lines

Combined type included those who meet the criteria of both anisometropia and strabismus

Must not have

Born before 32 weeks gestational age

Congenital or acquired macular pathology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Wearing an eye patch might cause discomfort or skin irritation around the patched area. Visual exercises may lead to eyestrain, headaches, or temporary dizziness but typically don't cause serious side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child's weaker eye sees worse than 20/40 and has a significant difference compared to the better eye.

Select...

I have both uneven eye prescription and misaligned eyes.

Select...

I am between 8-16 years old with strabismic amblyopia, prescribed foveation therapies.

Select...

My lazy eye is due to a difference in vision or eye alignment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I was born prematurely, before 32 weeks of pregnancy.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

OCT eccentric fixation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: foveation therapyExperimental Treatment1 Intervention

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

Group II: Patching groupExperimental Treatment1 Intervention

part-time patching following PEDIG guidelines.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

eye patch

2016

N/A

~80

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Lazy Eye (Amblyopia) include patching the stronger eye, atropine drops, and vision therapy. Patching forces the weaker eye to work harder, thereby improving its visual acuity and alignment. Atropine drops blur vision in the stronger eye, similarly encouraging use of the weaker eye. Vision therapy involves exercises that enhance eye coordination and focus. Optical Coherence Tomography (OCT) is used to measure eccentric fixation, fixation eye movement, and macular sensitivity, providing detailed insights into the structural and functional improvements in the amblyopic eye. These treatments are crucial as they help in the development of normal vision by promoting the use of the weaker eye, thereby preventing long-term visual impairment.

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