Skip to content

A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD

A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07470164
Acronym
ETS4
Enrollment
244
Registered
2026-03-13
Start date
2027-01-01
Completion date
2030-01-01
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esotropia

Keywords

strabismus, pediatric, botox, botulinum toxin a

Brief 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. 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.

Interventions

DRUGBotulinum toxin A

BTX-A 4.0 units to each medial rectus

Graded bilateral medial rectus recession

Sponsors

Jaeb Center for Health Research
Lead SponsorOTHER
National Eye Institute (NEI)
CollaboratorNIH
Pediatric Eye Disease Investigator Group
CollaboratorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Months to 17 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Motor Alignment Success1 YearThe 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.

Contacts

CONTACTRaymond T Kraker, MSPH
rkraker@jaeb.org813-975-8690
CONTACTPEDIG Protocol Monitor
pedig@jaeb.org813-975-8690

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026