A Pragmatic, Randomized, Non-inferiority Trial Comparing the Effectiveness of Botulinum Toxin-based Treatment With Conventional Strabismus Surgery in Acquired Esotropia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 8
- 主要终点
- Number of patients with presence of binocular vision
研究概览
简要总结
The purpose of the study is to evaluate if strabismus can be successfully treated requiring less surgical interventions with a Botox-based treatment regimen compared to a purely surgery based treatment regimen.
Experimental arm: Botulinum toxin injection in the horizontal extraocular muscles.
Control (active comparator) arm: Strabismus surgery on the horizontal extraocular muscles. No investigational product is used.
In Switzerland the standard procedure for treating large angle esotropia is surgery, which is performed on the horizontal eye muscles that may be either recessed or shortened leading to reduced or increased muscle function respectively.
As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and thereby blocks the neuromuscular transmission thus inducing a palsy.
Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by basic research findings and leaves dedicated clinicians in the dark. The objective is to shed light into this field of clinical research, which may help to guide future pediatric ophthalmologists in their management of strabismic patients. In a best case scenario, the results from this trial will prevent strabismus operation for many children with acquired large angle esotropia.
详细描述
Patients with acquired large angle esotropia (an inward deviation of the ocular axis by more than 5°) that develops after one year of age have a potential to regain binocular vision if a retinal image appears on corresponding retinal areas of both eyes. The main goal of therapy in these patients is the restoration of binocular vision.
In Switzerland the standard procedure for treating large angle esotropia is surgery, which is performed on the horizontal eye muscles that may be either recessed or shortened leading to reduced or increased muscle function respectively.
As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and thereby blocks the neuromuscular transmission thus inducing a palsy.
Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by basic research findings and leaves dedicated clinicians in the dark. The goal is to shed light into this field of clinical research, which may help to guide future pediatric ophthalmologists in their management of strabismic patients.
The goal of the study is to test if, with a botulinum-toxin-based treatment regimen, strabismus can be successfully treated requiring less surgical interventions.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of trial participant and/or legal representative documented per signature
- •Age > 1 year and <17 years
- •Esotropia > 10Prisms
- •Indication for an intervention (either Botox or surgery) has been made.
- •Any of the following:
- •Presence of a secondary strabismus from binocular disruption the cause of the binocular disruption is no longer present
- •Decompensated microstrabismus
- •Decompensated phoria
- •Acute acquired esotropia
- •Positive test of binocular function at any time point in the past, including any of the following
- •Titmus test
- •Bagolini striated glasses test
- •Lang-stereo-test with correct naming of at least one panel
- •Good ocular alignment after 6 months of age on at least 2 photographs
排除标准
- •Known hypersensitivity to botulinum toxin
- •Known neuromuscular disorder
- •Known present neurological disorder affecting the central nervous system Including paresis on cranial nerves number 3, 4 and 6
- •Any of the following:
- •nystagmus
- •dissociated vertical deviation
- •Vertical deviation in any gaze direction greater than 5°
- •Incomitance with more than 5° of difference between the left and right horizontal gaze direction
- •Previous strabismus surgery
- •Previous Botulinum toxin treatment on extraocular muscles
- •Presence of ophthalmic pathologies significantly preventing binocular functions.
- •A significant alteration of binocular function is assumed if vision is smaller than 0.1 or the visual field has a horizontal diameter of less than 20°.
- •Pregnancy. A negative pregnancy test before randomization is required for all women of child-bearing potential.
- •Preterm children born before 36 weeks of gestation.
研究组 & 干预措施
Botox-based treatment regimen
First intervention is a Botulinum toxin type A injection. If further treatment is necessary, strabismus surgery can be performed.
干预措施: Botulinum toxin type A (Drug)
Botox-based treatment regimen
First intervention is a Botulinum toxin type A injection. If further treatment is necessary, strabismus surgery can be performed.
干预措施: Strabismus surgery (Procedure)
Surgery-based treatment regimen
First intervention is strabismus surgery. If further treatment is necessary, strabismus surgery can be repeated.
干预措施: Strabismus surgery (Procedure)
结局指标
主要结局
Number of patients with presence of binocular vision
时间窗: At 18 months
Presence of binocular vision is a binary variable set to yes when either of the following criteria is fulfilled: 1. No eye movement can be observed in the simultaneous prism covertest, performed according to the study specific SOP for full orthoptic workup, for both eyes measured at distance. This proves orthotropia and thus binocular vision can be assumed. 2. An esotropia of less than 5° is observed in the covertest at distance AND at near. In addition at least one binocular test demonstrates binocular vision. This proves compensated microstrabismus with anomalous retinal correspondence. Binocular tests: 1. Lang-Stereotest 2. Butterfly- Stereotest 3. Titmus test 4. Bagolini striated glasses test 5. TNO-Test 6. Pencil-Test
次要结局
- Number of patients with binocular vision(At 12 months)
- Number of surgeries needed per successful outcome(At 12 months, at 18 months)
- Number of surgeries per participant(At 12 months, at 18 months)
- Change in strabismus angle, measured in percent(At 12 months, at 18 months)
- Number of patients with treatment-specific presence of binocular vision(At 12 months, at 18 months)
- Number of patients with second intervention(At 12 months, at 18 months)
- Number of patients with incomitance(At 12 months, at 18 months)
- Binocular function, measured in arc seconds(At 12 months, at 18 months)