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New headset therapy may reduce need for repeat eye surgeries in kids

NCT ID NCT06529016

Disease control Sponsor: Virginia Commonwealth University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 4 times

Summary

This study tests a non-surgical treatment for intermittent exotropia, a condition where one eye drifts outward. Children aged 4-7 will use a special headset for one hour daily, six days a week, for 12 weeks. The goal is to improve eye control and reduce the need for surgery.

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

23 people

The number who actually took part.

Started

Jul 2024

Finished

Apr 2026

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

4 to 7 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: * Diagnosed with IXT * one eye that is their preferred eye * ages 4-7 * distance control scores of \<= 4 Exclusion Criteria: * distance control scores of 5 * patients with visual acuity with vision that is worse in one eye by greater than two lines * no preferred eye * patients who would be unable to tolerate wearing the headset for 1 hour/day, 6 days/week, for 12 weeks.

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Conditions

The condition(s) this trial relates to.

alternating exotropia intermittent squint

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Exotropia intermittent

Contacts and locations

Locations

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.