A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 244
- 主要终点
- Motor Alignment Success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Botox
Group assigned to receive BTX-A injection
干预措施: Botulinum toxin A (Drug)
Surgery
Group assigned to receive Graded bilateral medial rectus recession
干预措施: bilateral medial rectus recession (Procedure)
结局指标
主要结局
Motor Alignment Success
时间窗: 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.
次要结局
未报告次要终点