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Botox injections could replace surgery for kids with crossed eyes

NCT ID NCT07470164

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares Botox injections to standard surgery for treating childhood esotropia (crossed eyes) in 244 children. The goal is to see if Botox, a less invasive option, works as well as surgery to straighten the eyes. If successful, it could reduce risks from surgery and anesthesia and make treatment more accessible.

What this could mean

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

Active substance
Botulinum toxin A (Botox)
What this could lead to
If it works, this could offer a less invasive, safer, and cheaper alternative to surgery for treating crossed eyes in children.
What could go wrong
This is a Phase 3 trial, but it hasn't started recruiting yet. Botox may not work as well as surgery, and some children may still need additional treatment.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 244 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2030

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

4 months to 17 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.

1. A constant or intermittent ET needing intervention with BTX-A or surgery in the judgement of the investigator meeting one of the criteria below: Infantile Esotropia (IET) * Onset prior to six months of age by parental history. * Angle measuring \>10 to ≤ 30 PD by PACT in the primary position at distance fixation on an accommodative target. Acquired Non-accommodative Esotropia (ANAET) * Onset after six months of age by parental history * Angle decreases less than 10 PD by PACT in the primary position at distance fixation with hyperopic correction. * Residual angle measuring \>10 to ≤ 30 PD by SPCT in the primary position at distance fixation on an accommodative target. Acquired Partially Accommodative Esotropia (APAET) * Onset after six months of age by parental history * Angle decreases 10 PD or more by PACT in the primary position at distance fixation with correction. * Residual angle measuring \>10 to ≤ 30 PD by SPCT in the primary position at distance fixation on an accommodative target. 2. Age at enrollment: * For IET: \> 4 months to \<17 years old * For ANAET or APAET: \>6 months to \<17 years old 3. No myopia ≥ 6.00D SE 4. Current Spectacle Correction at Time of Enrollment * For IET: No spectacle wear prior to enrollment. * For ANAET or APAET: Must be wearing spectacles if significant refractive error as defined below based upon a cycloplegic refraction within 6 months of enrollment. If no significant refractive error, spectacles are at investigator discretion. In either case full hyperopic correction by cycloplegia worn for at least 2 weeks. 5. Requirements for Spectacle Correction (if worn) * If myopia is \< 6.00D SE, then full CR must be worn for at least 2 weeks. * For children \< 5 years of age who have significant hyperopic refractive error (CR ≥ +2.50D SE), full hyperopic correction, determined by CR must have been worn for at least 2 weeks. * For children ≥ age 5 years, with significant hyperopic refractive error who are unable to tolerate correction of full CR due to blur, then maximally-tolerated hyperopic correction determined both with and without cycloplegia is prescribed and must be worn for at least 2 weeks. * For patients who do not have significant hyperopic refractive error (CR \< +2.50D SE), whether to prescribe spectacles is at investigator discretion. However, if the investigator elects to prescribe spectacles, the full tolerated hyperopic correction determined with and without cycloplegia must have been worn for at least 2 weeks. 6. Parent or legal guardian available for follow-up, has home phone (or access to phone), and willing to be contacted by Jaeb Center staff 7. Gestational age \> 34 weeks 8. Birth weight \> 1500 grams 9. No use of atropine within the last two weeks. 10. No history of CNS disease (e.g., IVH, PVL, meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy) 11. No significant developmental delay in the investigator's judgment (isolated speech delay excepted) 12. No limitation of abduction consistent with paralytic or restrictive myopathy (minor limitation of abduction due to cross fixation is acceptable) 13. No craniofacial malformation affecting the orbits 14. No prior BTX-A injection for strabismus 15. No prior extraocular muscle surgery or intraocular surgery 16. No structural ocular abnormalities (e.g., media opacity, optic atrophy, optic nerve hypoplasia, retinal detachment) 17. No immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is investigative site personnel directly affiliated with this study or who is an employee of the Jaeb Center for Health Research.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

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