Acquired EsotropiaPhase 3BISSNCT03459092
Botox Instead of Strabismus Surgery (BISS)
A Phase 3 study testing Botulinum toxin type A and Strabismus surgery in people with Acquired Esotropia, run by Insel Gruppe AG, University Hospital Bern at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Acquired Esotropia
- What is being tested?
- Botulinum toxin type A and Strabismus surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 16 Aug 2018to 31 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Switzerland7 sites
Basel University Hopital
Basel
Bern University Hospital
Bern
Geneva University Hospital, HUG
Geneva
Lausanne Univeristy Hospital, CHUV
Lausanne
Luzerner Kantonsspital
Lucerne
Kantonsspital St. Gallen
Sankt Gallen
University Hospital Zürich
Zurich
About this study
Official title: A Pragmatic, Randomized, Non-inferiority Trial Comparing the Effectiveness of Botulinum Toxin-based Treatment With Conventional Strabismus Surgery in Acquired Esotropia.
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.
Read more
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.
Read the 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.
- Conditions
- Acquired Esotropia
- Being tested
- Botulinum toxin type A, Strabismus surgery
- Keywords
- Botulinum toxin, strabismus surgery, binocular vision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ADrug
Botulinum toxin injection in the horizontal extraocular muscles.
Strabismus surgeryProcedure or surgery
Strabismus surgery on the horizontal extraocular muscles
| Study group | Role | What they receive |
|---|---|---|
| Botox-based treatment regimen | Experimental | First intervention is a Botulinum toxin type A injection. If further treatment is necessary, strabismus surgery can be performed. Receives: Drug: Botulinum toxin type A; Procedure: Strabismus surgery |
| Surgery-based treatment regimen | Active comparator | First intervention is strabismus surgery. If further treatment is necessary, strabismus surgery can be repeated. Receives: Procedure: Strabismus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 18 months
Secondary outcomes (8)
Number of patients with second intervention
Rescue surgery in Botox-based treatment arm and second surgery in surgery arm
Measured: At 12 months, at 18 months
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
Measured: At 12 months
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
Measured: At 12 months, at 18 months
Number of patients with treatment-specific presence of binocular vision
For this outcome patients with a second intervention are defined as failures (no).
Measured: At 12 months, at 18 months
Number of surgeries per participant
Measured: At 12 months, at 18 months
Number of surgeries needed per successful outcome
Successful outcome = binocular vision
Measured: At 12 months, at 18 months
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
Measured: At 12 months, at 18 months
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
Measured: At 12 months, at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start16 Aug 2018
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Acquired EsotropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias Abegg, Professor, Principal investigator, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459092
- Sponsor's protocol ID
- 33IC30 173533
- Acronym
- BISS
- Status last verified
- Nov 2023
- First submitted
- 2 Mar 2018
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. Ophthalmology. 1980 Oct;87(10):1044-9. doi: 10.1016/s0161-6420(80)35127-0.
PubMed 7243198Tejedor J, Rodriguez JM. Early retreatment of infantile esotropia: comparison of reoperation and botulinum toxin. Br J Ophthalmol. 1999 Jul;83(7):783-7. doi: 10.1136/bjo.83.7.783.
PubMed 10381663Tejedor J, Rodriguez JM. Retreatment of children after surgery for acquired esotropia: reoperation versus botulinum injection. Br J Ophthalmol. 1998 Feb;82(2):110-4. doi: 10.1136/bjo.82.2.110.
PubMed 9613374Lee J, Harris S, Cohen J, Cooper K, MacEwen C, Jones S. Results of a prospective randomized trial of botulinum toxin therapy in acute unilateral sixth nerve palsy. J Pediatr Ophthalmol Strabismus. 1994 Sep-Oct;31(5):283-6. doi: 10.3928/0191-3913-19940901-03.
PubMed 7837013Carruthers JD, Kennedy RA, Bagaric D. Botulinum vs adjustable suture surgery in the treatment of horizontal misalignment in adult patients lacking fusion. Arch Ophthalmol. 1990 Oct;108(10):1432-5. doi: 10.1001/archopht.1990.01070120080033.
PubMed 2222277de Alba Campomanes AG, Binenbaum G, Campomanes Eguiarte G. Comparison of botulinum toxin with surgery as primary treatment for infantile esotropia. J AAPOS. 2010 Apr;14(2):111-6. doi: 10.1016/j.jaapos.2009.12.162.
PubMed 20451851McNeer KW, Tucker MG, Spencer RF. Botulinum toxin management of essential infantile esotropia in children. Arch Ophthalmol. 1997 Nov;115(11):1411-8. doi: 10.1001/archopht.1997.01100160581010.
PubMed 9366672Lueder GT, Galli M, Tychsen L, Yildirim C, Pegado V. Long-term results of botulinum toxin-augmented medial rectus recessions for large-angle infantile esotropia. Am J Ophthalmol. 2012 Mar;153(3):560-3. doi: 10.1016/j.ajo.2011.08.019. Epub 2011 Oct 13.
PubMed 21996305Gursoy H, Basmak H, Sahin A, Yildirim N, Aydin Y, Colak E. Long-term follow-up of bilateral botulinum toxin injections versus bilateral recessions of the medial rectus muscles for treatment of infantile esotropia. J AAPOS. 2012 Jun;16(3):269-73. doi: 10.1016/j.jaapos.2012.01.010.
PubMed 22681945Baggesen K, Arnljot HM. Treatment of congenital esotropia with botulinum toxin type A. Acta Ophthalmol. 2011 Aug;89(5):484-8. doi: 10.1111/j.1755-3768.2009.01737.x. Epub 2009 Oct 30.
PubMed 19878118Campos EC, Schiavi C, Bellusci C. Critical age of botulinum toxin treatment in essential infantile esotropia. J Pediatr Ophthalmol Strabismus. 2000 Nov-Dec;37(6):328-32; quiz 354-5. doi: 10.3928/0191-3913-20001101-05.
PubMed 11392405Biglan AW, Burnstine RA, Rogers GL, Saunders RA. Management of strabismus with botulinum A toxin. Ophthalmology. 1989 Jul;96(7):935-43. doi: 10.1016/s0161-6420(89)32776-x.
PubMed 2771360Kushner BJ, Morton GV. A randomized comparison of surgical procedures for infantile esotropia. Am J Ophthalmol. 1984 Jul 15;98(1):50-61. doi: 10.1016/0002-9394(84)90188-0.
PubMed 6377903Helveston EM, Ellis FD, Schott J, Mitchelson J, Weber JC, Taube S, Miller K. Surgical treatment of congenital esotropia. Am J Ophthalmol. 1983 Aug;96(2):218-28. doi: 10.1016/s0002-9394(14)77790-6.
PubMed 6881245Scheiman M, Ciner E, Gallaway M. Surgical success rates in infantile esotropia. J Am Optom Assoc. 1989 Jan;60(1):22-31.
PubMed 2644332
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic, Randomized, Non-inferiority Trial Comparing the Effectiveness of Botulinum Toxin-based Treatment With Conventional Strabismus Surgery in Acquired Esotropia.
- ClinicalTrials.gov ID
- NCT03459092
- Acronym / sponsor ID
- BISS / 33IC30 173533
- Conditions
- Acquired Esotropia
- Keywords
- Botulinum toxin, strabismus surgery, binocular vision
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox-based treatment regimen | Experimental | Drug: Botulinum toxin type A, Procedure: Strabismus surgeryFirst intervention is a Botulinum toxin type A injection. If further treatment is necessary, strabismus surgery can be performed. |
| Surgery-based treatment regimen | Active comparator | Procedure: Strabismus surgeryFirst intervention is strabismus surgery. If further treatment is necessary, strabismus surgery can be repeated. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (14 listed)
- 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:
- Vertical deviation in any gaze direction greater than 5°
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type ABotulinum toxin injection in the horizontal extraocular muscles. | Drug | Botox-based treatment regimen |
| Strabismus surgeryStrabismus surgery on the horizontal extraocular muscles | Procedure or surgery | Botox-based treatment regimen, Surgery-based treatment regimen |
Primary outcome
Number of patients with presence of binocular vision
Time frame: 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
8 secondary outcomes
Number of patients with second intervention
Time frame: At 12 months, at 18 months
Number of patients with binocular vision
Time frame: At 12 months
Number of patients with incomitance
Time frame: At 12 months, at 18 months
Number of patients with treatment-specific presence of binocular vision
Time frame: At 12 months, at 18 months
Number of surgeries per participant
Time frame: At 12 months, at 18 months
Number of surgeries needed per successful outcome
Time frame: At 12 months, at 18 months
Change in strabismus angle, measured in percent
Time frame: At 12 months, at 18 months
Binocular function, measured in arc seconds
Time frame: At 12 months, at 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 7243198Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. Ophthalmology. 1980 Oct;87(10):1044-9. doi: 10.1016/s0161-6420(80)35127-0.
- Background: PubMed 10381663Tejedor J, Rodriguez JM. Early retreatment of infantile esotropia: comparison of reoperation and botulinum toxin. Br J Ophthalmol. 1999 Jul;83(7):783-7. doi: 10.1136/bjo.83.7.783.
- Background: PubMed 9613374Tejedor J, Rodriguez JM. Retreatment of children after surgery for acquired esotropia: reoperation versus botulinum injection. Br J Ophthalmol. 1998 Feb;82(2):110-4. doi: 10.1136/bjo.82.2.110.
- Background: PubMed 7837013Lee J, Harris S, Cohen J, Cooper K, MacEwen C, Jones S. Results of a prospective randomized trial of botulinum toxin therapy in acute unilateral sixth nerve palsy. J Pediatr Ophthalmol Strabismus. 1994 Sep-Oct;31(5):283-6. doi: 10.3928/0191-3913-19940901-03.
- Background: PubMed 2222277Carruthers JD, Kennedy RA, Bagaric D. Botulinum vs adjustable suture surgery in the treatment of horizontal misalignment in adult patients lacking fusion. Arch Ophthalmol. 1990 Oct;108(10):1432-5. doi: 10.1001/archopht.1990.01070120080033.
- Background: PubMed 20451851de Alba Campomanes AG, Binenbaum G, Campomanes Eguiarte G. Comparison of botulinum toxin with surgery as primary treatment for infantile esotropia. J AAPOS. 2010 Apr;14(2):111-6. doi: 10.1016/j.jaapos.2009.12.162.
- Background: PubMed 9366672McNeer KW, Tucker MG, Spencer RF. Botulinum toxin management of essential infantile esotropia in children. Arch Ophthalmol. 1997 Nov;115(11):1411-8. doi: 10.1001/archopht.1997.01100160581010.
- Background: PubMed 21996305Lueder GT, Galli M, Tychsen L, Yildirim C, Pegado V. Long-term results of botulinum toxin-augmented medial rectus recessions for large-angle infantile esotropia. Am J Ophthalmol. 2012 Mar;153(3):560-3. doi: 10.1016/j.ajo.2011.08.019. Epub 2011 Oct 13.
- Background: PubMed 22681945Gursoy H, Basmak H, Sahin A, Yildirim N, Aydin Y, Colak E. Long-term follow-up of bilateral botulinum toxin injections versus bilateral recessions of the medial rectus muscles for treatment of infantile esotropia. J AAPOS. 2012 Jun;16(3):269-73. doi: 10.1016/j.jaapos.2012.01.010.
- Background: PubMed 19878118Baggesen K, Arnljot HM. Treatment of congenital esotropia with botulinum toxin type A. Acta Ophthalmol. 2011 Aug;89(5):484-8. doi: 10.1111/j.1755-3768.2009.01737.x. Epub 2009 Oct 30.
- Background: PubMed 11392405Campos EC, Schiavi C, Bellusci C. Critical age of botulinum toxin treatment in essential infantile esotropia. J Pediatr Ophthalmol Strabismus. 2000 Nov-Dec;37(6):328-32; quiz 354-5. doi: 10.3928/0191-3913-20001101-05.
- Background: PubMed 2771360Biglan AW, Burnstine RA, Rogers GL, Saunders RA. Management of strabismus with botulinum A toxin. Ophthalmology. 1989 Jul;96(7):935-43. doi: 10.1016/s0161-6420(89)32776-x.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Abegg, Professor principal investigator
Bern University Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin type A and Strabismus surgery in people with Acquired Esotropia, run by Insel Gruppe AG, University Hospital Bern at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with presence of binocular vision (time frame: At 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03459092, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.