Strabismic DeviationBotox SquintNCT07180394
Botulinum Toxin for Strabismus Treatment
A study testing Botox injection into extraocular muscles in people with Strabismic Deviation and Strabismus, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
The bacterial species Clostridium botulinum produces a class of neurotoxins known as botulinum toxin. At the neuromuscular junction, botulinum toxin A prevents acetylcholine from being released. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Strabismic Deviation, Strabismus
- What is being tested?
- Botox injection into extraocular muscles
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Sep 2025to 30 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Esotropia or exotropia presenting with a small-to-moderate angle deviation (<40 PD)
- Acute onset comitant esotropia
- Postoperative residual or consecutive strabismus (2-8 weeks postoperatively or later)
- Acute paralytic strabismus to alleviate diplopia while the palsy resolves (mainly sixth nerve palsies, sometimes fourth nerve palsy)
- Active thyroid eye disease (Graves Disease), inflamed or pre-phthisical eyes, when surgery is not recommended
- Adjunct to surgery for large-angle esotropia or sixth nerve palsy or for large-angle exotropia
- As a muscle sparing option in patients at risk of anterior segment ischemia
Who cannot join
- Unrealistic expectations
- Neuromuscular disorders: Amyotrophic Lateral Sclerosis (ALS), Myasthenia Gravis and Eaton-Lambert syndrome
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Sana Nadeem Associate Professor of Ophthalmology, FCPS, Fellowship in Ped Oph contact
Pakistan1 site
Fauji Foundation Hospital, Rawalpindi
Rawalpindi, Punjab Province, 44000
Dr. Sana NAdeem Assoc. Prof., FCPS, +923425402394, sana.nadeem@fui.edu.pk
Dr. Ayesha Saeed Public Health Officer, Ph.D. Biotechnology, +923325756579, ayeshasaeed@fui.edu.pk
About this study
The bacterial species Clostridium botulinum produces a class of neurotoxins known as botulinum toxin. At the neuromuscular junction, botulinum toxin A prevents acetylcholine from being released. Following a Botox intramuscular injection, the injected EOM becomes paralysed 2-4 days after the injection and remains so clinically for at least 5-8 weeks. Muscle function recovery takes five to fourteen weeks, depending on the injection site, volume, and concentration of the solution, as well as the innervation density.
Botulinum toxin treatment results in a pharmacologic recession of the injected extraocular muscle, and the muscle lengthens while its agonist contracts, paralysing it. Improved ocular alignment or a decrease in the severity of the deviation may last for a long time, even if the pharmaceutical impact normally goes away after three months.
Even after the pharmacologic effect has worn off, a number of elements, such as mechanical, proprioceptive, and binocular effects, may intervene during the period of muscle paralysis to help stabilise and improve alignment in strabismus patients over the long term.
Read the detailed description
Detailed Description: A Strabismus or squint is an ocular condition characterized by misalignment of the eyes. It derived from the Greek word "strabismos" meaning 'to look obliquely'. It can be categorized as congenital or acquired, based on onset; by direction; as concomitant or incomitant/paralytic; and as isolated or syndromic. The prevalence of strabismus in the general population ranges from 2-5%, with a lower prevalence of 0.6% observed in the Asian population.
Normal ocular alignment depends upon the integrity of the extraocular muscles, orbital connective tissues, cranial nerves supplying these muscles, fusion centers, and the visual cortex. The etiopathogenesis of strabismus involves abnormalities in binocular vision or neuromuscular control of ocular motility. Left untreated and unrecognized, strabismus can result in irreversible visual impairment, amblyopia, and abnormalities with binocular vision. Moreover, it can significantly impact the affected individual's personality and lead to undesirable cosmetic concerns, such as misdirected eyes, abnormal facial and head posture, and occasionally, peculiar eye movements like up-shoots or down-shoots. It also has psychosocial implications for those affected by it.
The standard therapy for strabismus is either correction of the refractive errors causing it or strabismus surgery under general anesthesia in our country. For optimal benefit, adjustable strabismus surgery is done for cooperative children and adults. This requires 4-6 hours for the general anesthesia to be worn off and may not be an option for very small children and babies, for whom optimal results may not be obtained, in addition to long general anesthesia time.
For more than thirty years, botulinum toxin A has been utilised as a pharmaceutical treatment for strabismus. The majority of the literature on strabismus views it primarily as a surgical substitute, contingent on the strabismologist's preference. But as time and experience have shown, Botulinum toxin is not just an alternate treatment; it also has some other indications in which surgery is not a smart choice. Although there are few randomised controlled trials, Botulinum toxin appears to work similarly to surgery for certain motility issues. Botulinum toxin produces a "chemodenervation" effect, inhibits the release of acetylcholine, and tampers with calcium metabolism. The paralytic effect lasts for two months after injection into an EOM, with the maximal effect occurring in five to seven days. BTXA's overall weakening impact lasts for six to nine months. It is anticipated that the antagonist will experience a relative contraction when under the influence of Botulinum toxin.
Although Botulinum toxin has a short-term impact on extraocular muscles (EOM), it may lead to a long-term reduction in deviation. Potential explanations for this long-lasting effect could include changes in the number of sarcomeres during its effect, immunohistochemical modifications, and central adaptive mechanisms that show up as better binocularity.
The primary goal of this study is to examine the efficacy and outcomes of botulinum toxin intramuscular injection therapy in the treatment of pediatric or adult strabismus, instead of performing surgery in these patients.
Our plan to use the Botulinum toxin in various doses by injecting it into the overacting extraocular musces in strabismus patients, especially pediatric, but also adult cases, to use it as an alternative for strabismus surgery. For children, it will be administered under sedation or general anesthesia and in adults, under topical anesthesia under sterile aseptic techniques. The preoperative and postoperative measurements of the type of strabismus, patterns, deviation, and post-operative results will be studied both in the short and long-term.
- Conditions
- Strabismic Deviation, Strabismus
- Being tested
- Botox injection into extraocular muscles
- Keywords
- Strabismus, esotropia, exotropia, hypotropia, hypertropia, Botulinum toxin, therapy, outcomes
- Medical subject headings
- Strabismus, Esotropia, Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox injection into extraocular musclesDrug
Botulinum toxin in various doses by injecting it into the overacting extraocular musces in strabismus patients, especially pediatric, but also adult cases, to use it as an alternative for strabismus surgery. For children, it will be administered under sedation or general anesthesia and in adults, under topical anesthesia. The pre-operative measurements of the type of strabismus, patterns, deviation, and post-operative results will be studied both in the short and long-term.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin for strabismus treatment | Experimental | The primary objective is to examine the efficacy and outcomes of Botox (botulinum toxin) intramuscular injection therapy in the treatment of pediatric or adult strabismus Receives: Drug: Botox injection into extraocular muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Strabismus Angle in Prism Diopters (PD) in the Primary Position from the baseline angle at Week 2, Week 6, 3 months, 6 months, 9 months, and 1 year of the first intramuscular botox injection.
Using the prism cover test (PCT), the strabismus angle in the primary position was determined. The mean of the strabismus angle when viewed from a distance of 6 meters and when viewed from a distance of 33 centimetres was used to calculate the strabismus angle. The same afflicted eye (either the left or the right) was used for each participant's examination for the course of the trial. The difference between the values at Week 2, Week 6, 3 months, 6 months, 9 months, and 1 year and baseline, was used to compute the change from Baseline.
Measured: Baseline, at 2 weeks post injection, to 1 year post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Aug 2030 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Strabismic DeviationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The primary objective is to examine the efficacy and outcomes of Botox (botulinum toxin) intramuscular injection therapy in the treatment of pediatric or adult strabismus
- Masking
- None (open label)
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Saeed, Foundation University Islamabad
- Investigators
- Dr. Sana Nadeem Assoc. Prof., FCPS, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180394
- Sponsor's protocol ID
- FUMCRCT2
- Other IDs
- 1004/RC/FFH/RWP
- Acronym
- Botox Squint
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the data may be made available in the public repository, or on request from PI
Publications
Badakere A, Badrinath V, Dhillon HK, Valliappan A, Natarajan V, Agarkar S. Botulinum toxin A as a treatment modality for acute acquired comitant esotropia - An Indian perspective. Indian J Ophthalmol. 2025 Feb 1;73(2):228-230. doi: 10.4103/IJO.IJO_2198_23. Epub 2024 Aug 14.
PubMed 39186638Scott AB, Fahn S, Brin MF. Treatment of strabismus and blepharospasm with Botox (onabotulinumtoxinA): Development, insights, and impact. Medicine (Baltimore). 2023 Jul 1;102(S1):e32374. doi: 10.1097/MD.0000000000032374.
PubMed 37499080Bort-Marti AR, Rowe FJ, Ruiz Sifre L, Ng SM, Bort-Marti S, Ruiz Garcia V. Botulinum toxin for the treatment of strabismus. Cochrane Database Syst Rev. 2023 Mar 14;3(3):CD006499. doi: 10.1002/14651858.CD006499.pub5.
PubMed 36916692
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin for Strabismus Treatment
- ClinicalTrials.gov ID
- NCT07180394
- Acronym / sponsor ID
- Botox Squint / FUMCRCT2
- Conditions
- Strabismic Deviation, Strabismus
- Keywords
- Strabismus, esotropia, exotropia, hypotropia, hypertropia, Botulinum toxin, therapy, outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Aug 2030 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 18 Sep 2025 (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 bacterial species Clostridium botulinum produces a class of neurotoxins known as botulinum toxin. At the neuromuscular junction, botulinum toxin A prevents acetylcholine from being released. Following a Botox intramuscular injection, the injected EOM becomes paralysed 2-4 days after the injection and remains so clinically for at least 5-8 weeks. Muscle function recovery takes five to fourteen weeks, depending on the injection site, volume, and concentration of the solution, as well as the innervation density.
Botulinum toxin treatment results in a pharmacologic recession of the injected extraocular muscle, and the muscle lengthens while its agonist contracts, paralysing it. Improved ocular alignment or a decrease in the severity of the deviation may last for a long time, even if the pharmaceutical impact normally goes away after three months.
Even after the pharmacologic effect has worn off, a number of elements, such as mechanical, proprioceptive, and binocular effects, may intervene during the period of muscle paralysis to help stabilise and improve alignment in strabismus patients over the long term.
Detailed description
Detailed Description: A Strabismus or squint is an ocular condition characterized by misalignment of the eyes. It derived from the Greek word "strabismos" meaning 'to look obliquely'. It can be categorized as congenital or acquired, based on onset; by direction; as concomitant or incomitant/paralytic; and as isolated or syndromic. The prevalence of strabismus in the general population ranges from 2-5%, with a lower prevalence of 0.6% observed in the Asian population.
Normal ocular alignment depends upon the integrity of the extraocular muscles, orbital connective tissues, cranial nerves supplying these muscles, fusion centers, and the visual cortex. The etiopathogenesis of strabismus involves abnormalities in binocular vision or neuromuscular control of ocular motility. Left untreated and unrecognized, strabismus can result in irreversible visual impairment, amblyopia, and abnormalities with binocular vision. Moreover, it can significantly impact the affected individual's personality and lead to undesirable cosmetic concerns, such as misdirected eyes, abnormal facial and head posture, and occasionally, peculiar eye movements like up-shoots or down-shoots. It also has psychosocial implications for those affected by it.
The standard therapy for strabismus is either correction of the refractive errors causing it or strabismus surgery under general anesthesia in our country. For optimal benefit, adjustable strabismus surgery is done for cooperative children and adults. This requires 4-6 hours for the general anesthesia to be worn off and may not be an option for very small children and babies, for whom optimal results may not be obtained, in addition to long general anesthesia time.
For more than thirty years, botulinum toxin A has been utilised as a pharmaceutical treatment for strabismus. The majority of the literature on strabismus views it primarily as a surgical substitute, contingent on the strabismologist's preference. But as time and experience have shown, Botulinum toxin is not just an alternate treatment; it also has some other indications in which surgery is not a smart choice. Although there are few randomised controlled trials, Botulinum toxin appears to work similarly to surgery for certain motility issues. Botulinum toxin produces a "chemodenervation" effect, inhibits the release of acetylcholine, and tampers with calcium metabolism. The paralytic effect lasts for two months after injection into an EOM, with the maximal effect occurring in five to seven days. BTXA's overall weakening impact lasts for six to nine months. It is anticipated that the antagonist will experience a relative contraction when under the influence of Botulinum toxin.
Although Botulinum toxin has a short-term impact on extraocular muscles (EOM), it may lead to a long-term reduction in deviation. Potential explanations for this long-lasting effect could include changes in the number of sarcomeres during its effect, immunohistochemical modifications, and central adaptive mechanisms that show up as better binocularity.
The primary goal of this study is to examine the efficacy and outcomes of botulinum toxin intramuscular injection therapy in the treatment of pediatric or adult strabismus, instead of performing surgery in these patients.
Our plan to use the Botulinum toxin in various doses by injecting it into the overacting extraocular musces in strabismus patients, especially pediatric, but also adult cases, to use it as an alternative for strabismus surgery. For children, it will be administered under sedation or general anesthesia and in adults, under topical anesthesia under sterile aseptic techniques. The preoperative and postoperative measurements of the type of strabismus, patterns, deviation, and post-operative results will be studied both in the short and long-term.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The primary objective is to examine the efficacy and outcomes of Botox (botulinum toxin) intramuscular injection therapy in the treatment of pediatric or adult strabismus
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin for strabismus treatment | Experimental | Drug: Botox injection into extraocular musclesThe primary objective is to examine the efficacy and outcomes of Botox (botulinum toxin) intramuscular injection therapy in the treatment of pediatric or adult strabismus |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Esotropia or exotropia presenting with a small-to-moderate angle deviation (<40 PD)
Key exclusion criteria (3 listed)
- Unrealistic expectations
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 |
|---|---|---|
| Botox injection into extraocular musclesBotulinum toxin in various doses by injecting it into the overacting extraocular musces in strabismus patients, especially pediatric, but also adult cases, to use it as an alternative for strabismus surgery. For children, it will be administered under sedation or general anesthesia and in adults, under topical anesthesia. The pre-operative measurements of the type of strabismus, patterns, deviation, and post-operative results will be studied both in the short and long-term. | Drug | Botulinum toxin for strabismus treatment |
Primary outcome
Change in Strabismus Angle in Prism Diopters (PD) in the Primary Position from the baseline angle at Week 2, Week 6, 3 months, 6 months, 9 months, and 1 year of the first intramuscular botox injection.
Time frame: Baseline, at 2 weeks post injection, to 1 year post injection
Using the prism cover test (PCT), the strabismus angle in the primary position was determined. The mean of the strabismus angle when viewed from a distance of 6 meters and when viewed from a distance of 33 centimetres was used to calculate the strabismus angle. The same afflicted eye (either the left or the right) was used for each participant's examination for the course of the trial. The difference between the values at Week 2, Week 6, 3 months, 6 months, 9 months, and 1 year and baseline, was used to compute the change from Baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Background: PubMed 39186638Badakere A, Badrinath V, Dhillon HK, Valliappan A, Natarajan V, Agarkar S. Botulinum toxin A as a treatment modality for acute acquired comitant esotropia - An Indian perspective. Indian J Ophthalmol. 2025 Feb 1;73(2):228-230. doi: 10.4103/IJO.IJO_2198_23. Epub 2024 Aug 14.
- Background: PubMed 37499080Scott AB, Fahn S, Brin MF. Treatment of strabismus and blepharospasm with Botox (onabotulinumtoxinA): Development, insights, and impact. Medicine (Baltimore). 2023 Jul 1;102(S1):e32374. doi: 10.1097/MD.0000000000032374.
- Background: PubMed 36916692Bort-Marti AR, Rowe FJ, Ruiz Sifre L, Ng SM, Bort-Marti S, Ruiz Garcia V. Botulinum toxin for the treatment of strabismus. Cochrane Database Syst Rev. 2023 Mar 14;3(3):CD006499. doi: 10.1002/14651858.CD006499.pub5.
- Individual participant dataSharing planned: Undecided. the data may be made available in the public repository, or on request from PI
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.
Dr. Sana Nadeem Associate Professor of Ophthalmology, FCPS, Fellowship in Ped Oph contact
Dr. Sana Nadeem Assoc. Prof., FCPS principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox injection into extraocular muscles in people with Strabismic Deviation and Strabismus, run by Foundation University Islamabad at 1 site in Pakistan.
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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Sana Nadeem Associate Professor of Ophthalmology, FCPS, Fellowship in Ped Oph (+923425402394, sana.nadeem@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Strabismus Angle in Prism Diopters (PD) in the Primary Position from the baseline angle at Week 2, Week 6, 3 months, 6 months, 9 months, and 1 year of the first intramuscular botox injection. (time frame: Baseline, at 2 weeks post injection, to 1 year post injection). 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 NCT07180394, which also lists 3 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 18 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.