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Botox shots in the eye may replace surgery for strabismus

NCT ID NCT07180394

Disease control Sponsor: Foundation University Islamabad 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether injecting Botox into the eye muscles can correct strabismus (misaligned eyes) without surgery. 127 children and adults with small-to-moderate eye turns will receive Botox injections, and their eye alignment will be tracked for a year. The goal is to see if this temporary paralysis leads to lasting improvement.

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 (Botox) injection into eye muscles
What this could lead to
If successful, this could offer a less invasive alternative to surgery for correcting eye misalignment, with lasting improvement even after the drug wears off.
What could go wrong
This is an early-stage, non-randomized trial with no control group. The effect is temporary (muscle paralysis lasts weeks), and long-term alignment may not hold for everyone. Risks include double vision, droopy eyelid, or need for repeat injections.

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 127 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Aug 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

1 month and older

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: * Esotropia or exotropia presenting with a small-to-moderate angle deviation (\<40 PD) * Acute onset comitant esotropia * Postoperative residual or consecutive strabismus (2-8 weeks postoperatively or later) * Acute paralytic strabismus to alleviate diplopia while the palsy resolves (mainly sixth nerve palsies, sometimes fourth nerve palsy) * Active thyroid eye disease (Graves Disease), inflamed or pre-phthisical eyes, when surgery is not recommended * Adjunct to surgery for large-angle esotropia or sixth nerve palsy or for large-angle exotropia * As a muscle sparing option in patients at risk of anterior segment ischemia Exclusion Criteria: * Unrealistic expectations * Neuromuscular disorders: Amyotrophic Lateral Sclerosis (ALS), Myasthenia Gravis and Eaton-Lambert syndrome * Pregnancy and breastfeeding

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Conditions

The condition(s) this trial relates to.

esotropia exotropia strabismus

As listed by the trial registrant

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

Strabismic deviation Strabismus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fauji Foundation Hospital, Rawalpindi

    Rawalpindi, Punjab Province, 44000, Pakistan

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