A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD (ETS4)

March 31, 2026 updated by: Jaeb Center for Health Research

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Raymond T Kraker, MSPH
  • Phone Number: 813-975-8690
  • Email: rkraker@jaeb.org

Study Contact Backup

  • Name: PEDIG Protocol Monitor
  • Phone Number: 813-975-8690
  • Email: pedig@jaeb.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Botox
Group assigned to receive BTX-A injection
Drug: Botulinum toxin A
BTX-A 4.0 units to each medial rectus
Other Names:
  • Botox
Active Comparator: Surgery
Group assigned to receive Graded bilateral medial rectus recession
Procedure: bilateral medial rectus recession
Graded bilateral medial rectus recession
Other Names:
  • BMRrec

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jaeb Center for Health Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Eye Institute (NEI)
Pediatric Eye Disease Investigator Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ETS4
  • UG1EY011751 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be made available after publication of each primary manuscript.

IPD Sharing Access Criteria

Users accessing the data must enter an email address.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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