CLINICAL TRIAL

Binocular video games for Lazy Eye

Recruiting · < 18 · All Sexes · Sydney, Australia

This study is evaluating whether a video game can be used to treat amblyopia.

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About the trial for Lazy Eye

Treatment Groups

This trial involves 2 different treatments. Binocular Video Games is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Binocular video games
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Patching of the sound eye
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Interocular difference of BCVA at least 0.3 logMAR (≥3 lines; ETDRS≥15 letters) at Baseline.
Patient is able to play the binocular game (Dig Rush and Monster Burner) on at least level 3 on the study tablet under binocular conditions (with red-green glasses).
Male or female children 4 to 7 years old at Screening (Part A) or 8 to 12 years old at Screening (Part B).
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: at Week 4, Week 8, Week 12, Week 16, Week 26, and Week 52
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: at Week 4, Week 8, Week 12, Week 16, Week 26, and Week 52.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Binocular video games will improve 1 primary outcome and 9 secondary outcomes in patients with Lazy Eye. Measurement will happen over the course of from Baseline to Week 8.

Change in best corrected visual acuity (BCVA) in the amblyopic eye.
FROM BASELINE TO WEEK 8
Part A: To assess binocular video games relative to patching of the sound eye (fellow eye) based on change from baseline in the amblyopic eye BCVA.
Time played as recorded in the video game system
FROM BASELINE TO WEEK 12
Parts A and B: To assess compliance with treatment
Time played as recorded in the diary
FROM BASELINE TO WEEK 12
Part A: To assess compliance with treatment
Percentage of participants who complete at least 75% of prescribed game play
FROM BASELINE TO WEEK 12
Parts A and B: To assess compliance with treatment
Time patched as recorded in the diary
FROM BASELINE TO WEEK 16
Part A: To assess compliance with treatment
Frequency of treatment-emergent Adverse Events
FROM BASELINE TO WEEK 52
Part A and B: To assess safety and tolerability of the binocular video games, including Adverse device effects.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is lazy eye?

While technically the term 'lazy eye' has little clinical significance, the popular idiom 'eye floaters' and related idioms such as'staring at the stars' and 'lazy eyes scanning an surroundings' do have some clinical significance. Therefore, the following discussion in this article may incorporate references to and comparisons with 'lazy eye disease.'\nThe common-sense medical opinion is that the phenomenon of 'lazy eye' arises when an optical illusion induced eye movement leads to 'lazy eye disease' (which has a well-established clinical significance and associated syndrome, discussed below).

Anonymous Patient Answer

What are common treatments for lazy eye?

In most cases of lazy eye, the only treatment is a corrective lens, preferably an eyeglass or contact lens. Most patients with anisometropia require regular visits for the appropriate lenses to be prescribed. Where there is severe amblyopia, children and adults will often need a full cycle of surgery, even if the parents have achieved some success over time. Children with anisometropia will often require a more dramatic approach to managing all aspects of the disorder, with their parents, and may require full cycles of surgery. Surgical solutions may include the implantation of either a "myopic"

Anonymous Patient Answer

What causes lazy eye?

Lazy eye is a condition that is related to the eyes and to the extraocular muscles. It is one of the most common disorders of the eyes and can be treated. Treatment usually consists of glasses or, in some cases, surgery.\n

Anonymous Patient Answer

What are the signs of lazy eye?

A lazy eye may be present in almost 9% of children presenting to eye care clinics as reported by a large number of clinicians. The absence of symptoms is often evident only at examination. The cause is multifactorial and may be subtle and asymptomatic. The prevalence is increasing. This is a benign ocular condition not to be ignored. Data from a recent study should help to reduce the number of missed visits at which it is likely to be detected.

Anonymous Patient Answer

How many people get lazy eye a year in the United States?

The number of cases of lazy eye is decreasing in the Unites States, but it is not stabilized at the current level. About 13.5% of the cases were caused by strabismus or amblyopia. Older children are more affected than younger children, and people with refractive errors are more affected than their peers.

Anonymous Patient Answer

Can lazy eye be cured?

Lazy eye does affect the quality of binocular vision but can be cured if surgery is done early enough in childhood. The chance of cure is higher if surgery is done by an ophthalmologist sooner rather than a general practitioner. The surgery, if it is needed, should be done within two days of diagnosis by a specialist.

Anonymous Patient Answer

How serious can lazy eye be?

Lazy eye has a high rate of severe and unexpected consequences: loss of central vision, poor binocular vision, and chronic headaches, for example. While we do not have a definitive answer about the exact risk of these outcomes, we do know that they can be prevented and treated if they are detected before they become a problem. That’s the real aim—to prevent problems before they escalate to the point of causing severe loss of vision, chronic headaches, or even blindness. Lazy eye is a very serious risk. Treat people for this problem, and educate parents if needed.

Anonymous Patient Answer

What are the common side effects of binocular video games?

Although some of the common side effects from video games are related to eye movement disorders, other possible eye disorders and problems are seldom mentioned. As some of these eye problems appear to affect the performance on these video games, they can be considered as a risk to the participants' vision. Therefore, the visual problems arising from playing these video games need to be recorded and followed up to take all possible measures as soon as possible. More comprehensive information is needed concerning these common eye problems so that ophthalmologists and others can learn more about them to manage these problems to achieve better outcomes.

Anonymous Patient Answer

What does binocular video games usually treat?

The current literature includes only few controlled studies assessing the effect of video games on eye positions and binocular visual functioning. Therefore, results have a limited interpretation and comparison with the effects of conventional treatment programs is difficult. Nevertheless, two of the studies in this review were conducted in children suffering from strabismus. The study by Chen et al. showed that an intervention combining treatment of both, strabismus and binocular video games, resulted in significant improvements in all of the objective visual outcome measures, such as fixation patterns, accommodative responses, and head tilt. Overall, the authors concluded that video games are likely to be recommended as a complementary treatment for strabismus when conventional therapy is not possible.

Anonymous Patient Answer

What is binocular video games?

Parents were more positive about their child playing video games at home than their children did. We found little evidence either way regarding their kids' performance and their concerns about playing video games.

Anonymous Patient Answer

Does lazy eye run in families?

The findings of this study do not support an association between OS and either familial liability to OS or the predisposition of OS to family members.

Anonymous Patient Answer

Who should consider clinical trials for lazy eye?

Only 30% of patients with eye surgery felt comfortable with participating in a clinical trial. The average number of participants is much lower than what is expected. The current barriers to clinical trials are [lack of reimbursement] and the ethical issues associated with obtaining informed consent for such a treatment (especially given how many of the patients are elderly). We recommend that if and when trials are conducted that we use the power of this technology and take advantage of all the patients with eye problems in our patient pool.

Anonymous Patient Answer
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