EsotropiaPhase 3ETS4NCT07470164
A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD
A Phase 3 study testing Botulinum toxin A and bilateral medial rectus recession in people with Esotropia, run by Jaeb Center for Health Research.
Trial summary
Childhood esotropia (ET) is a common cause of visual disability, and its early management is critical for optimal visual and developmental outcomes. The proposed study addresses a need to evaluate botulinum toxin A (BTX-A) as a less invasive, cost-effective alternative to incisional strabismus surgery. Read more about this study
- Who is it for?
- Ages 4 months to 17 years
- Conditions the study is for
- Esotropia
- What is being tested?
- Botulinum toxin A and bilateral medial rectus recession
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 17 years
- All sexes
- No healthy volunteers
- Child
- 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.
- Age at enrollment:
- For IET: > 4 months to <17 years old
- For ANAET or APAET: >6 months to <17 years old
- No myopia ≥ 6.00D SE
- 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.
- 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.
- Parent or legal guardian available for follow-up, has home phone (or access to phone), and willing to be contacted by Jaeb Center staff
- Gestational age > 34 weeks
- Birth weight > 1500 grams
- No use of atropine within the last two weeks.
- No history of CNS disease (e.g., IVH, PVL, meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy)
- No significant developmental delay in the investigator's judgment (isolated speech delay excepted)
- No limitation of abduction consistent with paralytic or restrictive myopathy (minor limitation of abduction due to cross fixation is acceptable)
- No craniofacial malformation affecting the orbits
- No prior BTX-A injection for strabismus
- No prior extraocular muscle surgery or intraocular surgery
- No structural ocular abnormalities (e.g., media opacity, optic atrophy, optic nerve hypoplasia, retinal detachment)
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Childhood esotropia (ET) is a common cause of visual disability, and its early management is critical for optimal visual and developmental outcomes.
The proposed study addresses a need to evaluate botulinum toxin A (BTX-A) as a less invasive, cost-effective alternative to incisional strabismus surgery. If BTX-A is demonstrated to be non-inferior to incisional strabismus surgery in treating ET >10 to ≤30PD, this could reduce surgical and anesthesia-related risks in infants, lower the economic burden on families and healthcare systems, and reduce disparities in access to care, particularly in underserved settings where surgical resources are limited.
Read the detailed description
After receiving informed consent, participants with ET >10 to ≤30PD who are otherwise eligible will be randomly assigned to treatment with BTX-A or incisional strabismus surgery; and seen 6 weeks, 6- and 12- months after surgery.
The primary outcome is the cumulative probability of motor alignment success by 12 months. Success is defined as the absence of failure by 12 months.
- Conditions
- Esotropia
- Being tested
- Botulinum toxin A, bilateral medial rectus recession
- Keywords
- strabismus, pediatric, botox, botulinum toxin a
- Medical subject headings
- Esotropia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin ADrug
Also called Botox
BTX-A 4.0 units to each medial rectus
bilateral medial rectus recessionProcedure or surgery
Also called BMRrec
Graded bilateral medial rectus recession
| Study group | Role | What they receive |
|---|---|---|
| Botox | Experimental | Group assigned to receive BTX-A injection Receives: Drug: Botulinum toxin A |
| Surgery | Active comparator | Group assigned to receive Graded bilateral medial rectus recession Receives: Procedure: bilateral medial rectus recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Alignment Success
The primary efficacy outcome will be motor alignment success defined as follows:
- Success is defined as the absence of failure by 1 year.
- Failure is defined as any of the following post-randomized treatment (BOTOX or SURGERY) up to 1 year:
- ET at distance (determined by a cover/uncover test) with a magnitude of >10 PD by SPCT at or after the 6-month masked exam.
- XT at distance at any time during the exam (determined by a cover/uncover test) with a magnitude of > 10 PD by SPCT at or after the 6-month masked exam.
- Second surgery or injection at any time after the initial surgery/injection through 12 months post-procedure.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsotropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470164
- Sponsor's protocol ID
- ETS4
- Other IDs
- UG1EY011751
- Acronym
- ETS4
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD
- ClinicalTrials.gov ID
- NCT07470164
- Acronym / sponsor ID
- ETS4 / ETS4
- Conditions
- Esotropia
- Keywords
- strabismus, pediatric, botox, botulinum toxin a
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood esotropia (ET) is a common cause of visual disability, and its early management is critical for optimal visual and developmental outcomes.
The proposed study addresses a need to evaluate botulinum toxin A (BTX-A) as a less invasive, cost-effective alternative to incisional strabismus surgery. If BTX-A is demonstrated to be non-inferior to incisional strabismus surgery in treating ET >10 to ≤30PD, this could reduce surgical and anesthesia-related risks in infants, lower the economic burden on families and healthcare systems, and reduce disparities in access to care, particularly in underserved settings where surgical resources are limited.
Detailed description
After receiving informed consent, participants with ET >10 to ≤30PD who are otherwise eligible will be randomly assigned to treatment with BTX-A or incisional strabismus surgery; and seen 6 weeks, 6- and 12- months after surgery.
The primary outcome is the cumulative probability of motor alignment success by 12 months. Success is defined as the absence of failure by 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox | Experimental | Drug: Botulinum toxin AGroup assigned to receive BTX-A injection |
| Surgery | Active comparator | Procedure: bilateral medial rectus recessionGroup assigned to receive Graded bilateral medial rectus recession |
Who may qualify
- Ages
- 4 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin AAlso: BotoxBTX-A 4.0 units to each medial rectus | Drug | Botox |
| bilateral medial rectus recessionAlso: BMRrecGraded bilateral medial rectus recession | Procedure or surgery | Surgery |
Primary outcome
Motor Alignment Success
Time frame: 1 Year
The primary efficacy outcome will be motor alignment success defined as follows: 1. Success is defined as the absence of failure by 1 year. 2. Failure is defined as any of the following post-randomized treatment (BOTOX or SURGERY) up to 1 year: * ET at distance (determined by a cover/uncover test) with a magnitude of >10 PD by SPCT at or after the 6-month masked exam. * XT at distance at any time during the exam (determined by a cover/uncover test) with a magnitude of > 10 PD by SPCT at or after the 6-month masked exam. * Second surgery or injection at any time after the initial surgery/injection through 12 months post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- PEDIG Public WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.
Related trials for Esotropia
Active, not recruitingObservational study
An Observational Cohort Study to Explore the Clinical Outcome of Congenital Strabismmus Based on Etiology and Timing of Surgery
Congenital Esotropia
RecruitingObservational study
Eye-Hand Cross-Dominance and Upper Extremity Performance in Volleyball Players
Volleyball Player
Recruiting
Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia
Esotropia
Not yet recruiting
Visual Therapy for Intermittent Strabismus
Intermittent Strabismus, Exotropia Intermittent
Not yet recruiting
Risk Factors And Surgical Outcomes Of Strabismus Reoperation
Strabismus, Esotropia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin A and bilateral medial rectus recession in people with Esotropia, run by Jaeb Center for Health Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raymond T Kraker, MSPH (813-975-8690, rkraker@jaeb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Alignment Success (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.