Vision Training + Binocular Deprivation for Lazy Eye

(LUMA Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: State University of New York College of Optometry
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if living in complete darkness for five to ten days can help adults with amblyopia, also known as lazy eye, improve their vision. Amblyopia occurs when one eye has weaker vision due to receiving lower-quality visual input than the other eye during childhood. Participants will either undergo binocular deprivation (living in complete darkness) followed by vision training or receive only vision training. Individuals with moderate to severe amblyopia who live near New York City might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to explore innovative treatment methods for improving vision in adults with amblyopia.

Will I have to stop taking my current medications?

If you are taking anti-depressant or anti-anxiety drugs, you will need to stop, as people on these medications are excluded from the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments involving binocular deprivation, where both eyes are temporarily blocked from seeing, may improve vision in adults with amblyopia. Studies have found that temporarily turning off the dominant eye aids recovery more effectively than covering one eye alone. This suggests the method is generally safe and could be effective.

For vision training, less direct evidence on safety is available from the sources provided. However, vision training is a non-invasive technique often used to improve visual skills. It does not involve medication or surgery, which usually makes it well-tolerated.

Overall, while specific safety data for these treatments are not detailed, the nature of the treatments—especially non-invasive ones like vision training—often suggests they are safe.12345

Why are researchers excited about this trial?

Most treatments for amblyopia, like patching or atropine drops, focus on strengthening the weaker eye by forcing it to work harder. But researchers are exploring a different approach with binocular deprivation, which involves short-term light deprivation followed by vision training. This method is unique because it aims to reset the brain's visual processing, potentially speeding up improvement. Another arm of the trial focuses solely on vision training, offering an alternative to traditional treatments that could enhance visual acuity without the need for covering the stronger eye. Researchers are excited because these methods could lead to faster, more effective recovery for individuals with amblyopia.

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

This trial will compare two approaches to improving vision in adults with lazy eye (amblyopia). One group will undergo 10 days of visual deprivation followed by vision training, while the other group will receive vision training only. Research has shown that temporarily blocking vision in both eyes, followed by special vision exercises, might improve sight in adults with lazy eye. Studies have found that these exercises can greatly enhance how well both eyes work together, which is crucial for better vision. Early findings suggest that this approach can help the brain learn and improve vision, even in adults. While more research is needed, these initial results are promising for improving vision in conditions like lazy eye.26789

Who Is on the Research Team?

BT

Benjamin T Backus, PhD

Principal Investigator

Grad Ctr for Vision Research, SUNY College of Optometry

Are You a Good Fit for This Trial?

Inclusion Criteria

Adults age 18 or older
Moderate (20/30 to 20/80) to severe (20/100 to 20/400) amblyopia with a visual acuity of 20/25 or better in the fellow eye
Must live in or be commutable to the New York Metropolitan area

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
Comprehensive visual examination and interviews

Sequestration

Participants undergo visual deprivation for 0, 5, or 10 days to enhance synaptic plasticity

0, 5, or 10 days
Continuous sequestration

Vision Training

Participants engage in vision training through video game play to stimulate visual recovery

8 weeks
Regular vision testing

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 months
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Binocular deprivation
  • Vision training
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Visual Deprivation - 10 daysExperimental Treatment2 Interventions
Group II: Vision Training OnlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

State University of New York College of Optometry

Lead Sponsor

Trials
20
Recruited
1,100+

University of Maryland, College Park

Collaborator

Trials
163
Recruited
46,800+

Nova Southeastern University

Collaborator

Trials
103
Recruited
12,000+

National Eye Institute (NEI)

Collaborator

Trials
572
Recruited
1,320,000+

Citations

Efficacy and safety of augmented-reality pathway-specific ...The aim of this trial is to assess the efficacy and safety of this innovative binocular, home-based treatment for children and adults with ...
Binocular visual training to promote recovery from monocular ...The results of this study show that binocular visual training can be effective in promoting recovery after early monocular deprivation. We also uncovered a ...
Effect of visual perception training on binocular visual function ...After the vision training, the binocular visual perception functions of children in both groups were significantly improved compared with that before training ( ...
The Effectiveness of Binocular Virtual Reality Training on ...Our data suggested that binocular VR training can significantly improve the visual field defect of glaucoma patients but warrants further study with large ...
A Systematic Review and Meta-Analysis of Perceptual ...This meta-analysis aimed to analyze the effectiveness of perceptual learning and video game training for adults with amblyopia.
Long-term visual and treatment outcomes of whole ...There was no statistical difference in the odds of children from the 0–20% most deprived socioeconomic background having poorer visual outcomes ...
Investigation of the efficacy and safety of retinal inactivation ...These results provide evidence that inactivation of the dominant eye after a period of amblyogenic rearing promotes better recovery than eye occlusion.
(PDF) Degradation of Binocular Coordination during Sleep ...The study done by Tong et al [5] reported a degradation in stability of both binocular coordination and gaze-target synchronization after 26h of ...
Brief daily binocular vision prevents monocular deprivation ...Even short periods of early monocular deprivation result in reduced cortical representation and visual acuity of the deprived eye.
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