Light flicker tested as vision fix for older amblyopia patients

NCT ID NCT07846397

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 29, 2026 · Last updated Sep 30, 2026 · Updated 1 time

Summary

Researchers at Boston Children's Hospital are testing a handheld device that delivers flickering light to the eyes as a treatment for amblyopia, often called lazy eye. The trial enrolls people aged 14 to 40 with amblyopia caused by misaligned eyes or unequal refractive error, a group that typically does not respond to childhood treatments. Participants use the device at home for one hour a day over eight weeks. The study measures whether vision in the weaker eye improves and whether any gains last.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
flicker therapy delivered through a handheld light device used at home
What this could lead to
If it works, flicker therapy could offer a non-invasive, at-home option to improve vision in teens and adults with amblyopia, a group that has few proven treatments.
What could go wrong
This is a small, early trial with 10 participants, so results may not hold in larger groups. The 8-week treatment period is short, and any vision gains may fade after treatment stops.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥14 and ≤40 years * Amblyopia associated with strabismus and/or anisometropia * Criteria for strabismus: must meet at least one of the following: heterotropia at distance and/or near with or without spectacle correction, history of strabismus surgery, documented history of strabismus that is no longer present and felt by the investigator could have caused the amblyopia * Criteria for anisometropia: must meet at least one of the following: * ≥ 0.50 D difference in spherical equivalent between eyes * ≥ 1.50 D difference in astigmatism in any meridian between the eyes * Visual acuity measured in each eye within 7 days prior to enrollment using ETDRS protocol on a study certified visual acuity tester as follows: * Amblyopic eye visual acuity of 20/40 - 20/400 * Fellow eye visual acuity of ≥ 20/25. * Spectacle correction for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction \< 6 months old: * Requirement for spectacle correction: * Spherical equivalent must be within 0.50 D of fully correcting anisometropia * Hyperopia ≥ 3.00 D must be corrected * Hyperopia may not be under-corrected by \>1.50 D spherical equivalent and must be symmetrically reduced in each eye * Cylinder power must be within 0.50 D of fully correcting the astigmatism * Cylinder axis must be within 6 degrees of the axis when the cylinder power is ≥ 1.00 D * Myopia of the amblyopic eye \>0.50 D spherical equivalent must be corrected * Myopia may not be under-corrected by \>0.25 D or overcorrected by \> 0.50D * Spectacles meeting the above criteria must be worn until visual acuity in amblyopic eye has not improved ≥ 1 line (5 letters) by the same testing method during 2 consecutive visual acuity measurements at least 4 weeks apart (i.e. minimum of 12 weeks spectacle correction) * Dilated eye examination within 6 months prior to enrollment * Subject must be available for at least 4 months of follow-up, have access to a phone, and be willing to be contacted * By investigator judgment, the subject is likely to comply with prescribed treatment (i.e. no prior history of poor compliance) and complete all follow up visits Exclusion Criteria: * Myopia \> -6.00 D spherical equivalent * Presence of associated findings that could cause reduced visual acuity * Nystagmus does not exclude the subject if the above visual acuity criteria are met * Treatment with topical atropine within the past 12 weeks * Previous intraocular or refractive surgery * Strabismus surgery planned within 16 weeks * Current vision therapy or orthoptics * History of seizures * Known past or present susceptibility to seizures at the discretion of the investigator * Known past or present psychological problems * Known contraindications or inability to use of a head-mounted device (over one's glasses) and/or exposure to flickering light * Current use of medication for the treatment of seizures, bipolar disorder, or migraine * Use of any medication with neuromodulatory effects, including * Medications that reduce seizure thresholds

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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