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Botox Instead of Strabismus Surgery (BISS) (BISS)

Primary Purpose

Acquired Esotropia

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Botulinum toxin type A
Strabismus surgery
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Esotropia focused on measuring Botulinum toxin, strabismus surgery, binocular vision

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Informed consent of trial participant and/or legal representative documented per signature
  2. Age > 1 year and <17 years
  3. Esotropia > 10Prisms
  4. Indication for an intervention (either Botox or surgery) has been made.
  5. 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
  6. 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

Exclusion Criteria:

  1. Known hypersensitivity to botulinum toxin
  2. Known neuromuscular disorder
  3. Known present neurological disorder affecting the central nervous system Including paresis on cranial nerves number 3, 4 and 6
  4. Any of the following:

    • nystagmus
    • dissociated vertical deviation
  5. Vertical deviation in any gaze direction greater than 5°
  6. Incomitance with more than 5° of difference between the left and right horizontal gaze direction
  7. Previous strabismus surgery
  8. Previous Botulinum toxin treatment on extraocular muscles
  9. 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°.

  10. Pregnancy. A negative pregnancy test before randomization is required for all women of child-bearing potential.
  11. Preterm children born before 36 weeks of gestation.

Sites / Locations

  • Institut Ophtalmologique Sourdille Atlantique
  • Basel University Hopital
  • Bern University Hospital
  • Geneva University Hospital, HUG
  • Lausanne Univeristy Hospital, CHUV
  • Luzerner Kantonsspital
  • Kantonsspital St. Gallen
  • University Hospital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Botox-based treatment regimen

Surgery-based treatment regimen

Arm Description

First intervention is a Botulinum toxin type A injection. If further treatment is necessary, strabismus surgery can be performed.

First intervention is strabismus surgery. If further treatment is necessary, strabismus surgery can be repeated.

Outcomes

Primary Outcome Measures

Number of patients with presence of binocular vision
Presence of binocular vision is a binary variable set to yes when either of the following criteria is fulfilled: 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. 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: Lang-Stereotest Butterfly- Stereotest Titmus test Bagolini striated glasses test TNO-Test Pencil-Test

Secondary Outcome Measures

Number of patients with second intervention
Rescue surgery in Botox-based treatment arm and second surgery in surgery arm
Number of patients with binocular vision
Presence of binocular vision is a binary variable set to yes when either of the following criteria is fulfilled: 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. 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: Lang-Stereotest Butterfly- Stereotest Titmus test Bagolini striated glasses test TNO-Test Pencil-Test
Number of patients with incomitance
Incomitance is here defined as the absolute difference of strabismus angle measured with the alternate prism cover test at 25° left gaze and the angle measured at 25° right gaze
Number of patients with treatment-specific presence of binocular vision
For this outcome patients with a second intervention are defined as failures (no).
Number of surgeries per participant
Number of surgeries needed per successful outcome
Successful outcome = binocular vision
Change in strabismus angle, measured in percent
Measured as percentage of preoperative deviation from baseline. The strabismus angle measured with the alternate prism cover test, performed in primary position at distance is used. Change of deviation in percent of preoperative deviation is calculated as follows: 100*(preoperative deviation - postoperative deviation) / preoperative deviation
Binocular function, measured in arc seconds
When binocular vision is present, the binocular function is the best stereoscopic acuity, measured in arc seconds, achieved for any of the below mentioned tests. Lang-Stereotest Butterfly- Stereotest Titmus test Bagolini striated glasses test TNO-Test Pencil-Test

Full Information

First Posted
March 2, 2018
Last Updated
May 16, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03459092
Brief Title
Botox Instead of Strabismus Surgery (BISS)
Acronym
BISS
Official Title
A Pragmatic, Randomized, Non-inferiority Trial Comparing the Effectiveness of Botulinum Toxin-based Treatment With Conventional Strabismus Surgery in Acquired Esotropia.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. The primary objective is to test if the Botox-based treatment regimen is not inferior to surgical treatment in terms of orthotropic success. If this is shown, the number of surgeries required will be compared between the two groups (main secondary objective). The hypothesis is that the Botox-based treatment regimen, which permits performance of rescue surgery, is successful in a similar proportion of patients as the purely surgical approach. The second hypothesis is that only about 20% of patients treated with Botox require surgery at all as compared to about 10% of patients in the surgical arm that need a second surgery. Analysis of the primary outcome The proportion of orthotropic success for both groups will be calculated with a corresponding 95% confidence interval. For the comparison between the two groups, the stratified risk difference for the stratification factors used in randomization will be calculated with a corresponding one-sided lower 95% confidence limit. If the lower limit lies above -12%, non-inferiority will be claimed. Analysis of the main secondary outcome The proportion of second interventions for both groups will be calculated with a corresponding 95% confidence interval. For the comparison between the two groups, a stratified risk difference for the stratification factors used in randomization will be calculated with a corresponding one-sided upper 95% confidence limit. If the upper limit lies below 40% and if non-inferiority for the primary outcome could be demonstrated, a clinical benefit of the new treatment will be claimed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Esotropia
Keywords
Botulinum toxin, strabismus surgery, binocular vision

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Botox-based treatment regimen
Arm Type
Experimental
Arm Description
First intervention is a Botulinum toxin type A injection. If further treatment is necessary, strabismus surgery can be performed.
Arm Title
Surgery-based treatment regimen
Arm Type
Active Comparator
Arm Description
First intervention is strabismus surgery. If further treatment is necessary, strabismus surgery can be repeated.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Intervention Description
Botulinum toxin injection in the horizontal extraocular muscles.
Intervention Type
Procedure
Intervention Name(s)
Strabismus surgery
Intervention Description
Strabismus surgery on the horizontal extraocular muscles
Primary Outcome Measure Information:
Title
Number of patients with presence of binocular vision
Description
Presence of binocular vision is a binary variable set to yes when either of the following criteria is fulfilled: 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. 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: Lang-Stereotest Butterfly- Stereotest Titmus test Bagolini striated glasses test TNO-Test Pencil-Test
Time Frame
At 18 months
Secondary Outcome Measure Information:
Title
Number of patients with second intervention
Description
Rescue surgery in Botox-based treatment arm and second surgery in surgery arm
Time Frame
At 12 months, at 18 months
Title
Number of patients with binocular vision
Description
Presence of binocular vision is a binary variable set to yes when either of the following criteria is fulfilled: 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. 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: Lang-Stereotest Butterfly- Stereotest Titmus test Bagolini striated glasses test TNO-Test Pencil-Test
Time Frame
At 12 months
Title
Number of patients with incomitance
Description
Incomitance is here defined as the absolute difference of strabismus angle measured with the alternate prism cover test at 25° left gaze and the angle measured at 25° right gaze
Time Frame
At 12 months, at 18 months
Title
Number of patients with treatment-specific presence of binocular vision
Description
For this outcome patients with a second intervention are defined as failures (no).
Time Frame
At 12 months, at 18 months
Title
Number of surgeries per participant
Time Frame
At 12 months, at 18 months
Title
Number of surgeries needed per successful outcome
Description
Successful outcome = binocular vision
Time Frame
At 12 months, at 18 months
Title
Change in strabismus angle, measured in percent
Description
Measured as percentage of preoperative deviation from baseline. The strabismus angle measured with the alternate prism cover test, performed in primary position at distance is used. Change of deviation in percent of preoperative deviation is calculated as follows: 100*(preoperative deviation - postoperative deviation) / preoperative deviation
Time Frame
At 12 months, at 18 months
Title
Binocular function, measured in arc seconds
Description
When binocular vision is present, the binocular function is the best stereoscopic acuity, measured in arc seconds, achieved for any of the below mentioned tests. Lang-Stereotest Butterfly- Stereotest Titmus test Bagolini striated glasses test TNO-Test Pencil-Test
Time Frame
At 12 months, at 18 months
Other Pre-specified Outcome Measures:
Title
Total duration of binocular vision (exploratory outcome)
Description
The duration is calculated as the sum of time periods between consecutive assessments with presence of binocular vision.
Time Frame
At 12 months, at 18 months
Title
Incidence of short-term adverse events (safety outcome)
Description
Adverse event groups that will be evaluated separately are: Ptosis Double vision Subjective post-treatment discomfort/pain New vertical strabismus >1° Limitations of ocular motility
Time Frame
Within two weeks of intervention
Title
Incidence of ocular adverse events
Time Frame
Within 18 months
Title
Incidence of serious adverse events related to the treatment
Time Frame
Within 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias Abegg, Professor
Organizational Affiliation
Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Ophtalmologique Sourdille Atlantique
City
Saint-Herblain
Country
France
Facility Name
Basel University Hopital
City
Basel
Country
Switzerland
Facility Name
Bern University Hospital
City
Bern
Country
Switzerland
Facility Name
Geneva University Hospital, HUG
City
Geneva
Country
Switzerland
Facility Name
Lausanne Univeristy Hospital, CHUV
City
Lausanne
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Lucerne
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
Saint Gallen
Country
Switzerland
Facility Name
University Hospital Zürich
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified study dataset will be made publicly available for secondary analyses by publishing the data on a data sharing platform such as Dryad or BORIS, the public online data repository from the University of Bern.
IPD Sharing Time Frame
Once the primary analysis is published.
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