Acute Acquired Comitant EsotropiaNCT06966999
Efficacy of Botulinum Toxin Type A for Acute Acquired Comitant Esotropia: An Age-Stratified Two-Year Follow-Up Study
A study testing Botulinum Toxin Type A Injection [Botox] in people with Acute Acquired Comitant Esotropia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to assess and compare the efficacy of two-year follow-up botulinum toxin type A （BTXA) in the treatment of acute acquired comitant esotropia (AACE) across five age groups: ≤6 years, >6 to ≤12 years, >12 to ≤20 years, >20 to ≤30 years, and >30 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Acquired Comitant Esotropia
- What is being tested?
- Botulinum Toxin Type A Injection [Botox]
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jun 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute acquired comitant esotropia (AACE) with sudden onset and diplopia
- Normal eye movements with deviation difference ≤5 prism diopters (PD) in all gaze directions
- Hyperopia < +3.00 diopters
- <10 PD reduction in esotropia with hypermetropic spectacle correction
- No prior extraocular muscle surgery
- Absence of congenital/developmental anomalies affecting treatment outcomes
Who cannot join
- Deviation difference >5 PD in any gaze direction
- Hyperopia ≥ +3.00 diopters
- History of extraocular muscle surgery
- Presence of congenital/developmental anomalies potentially impacting outcomes
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
The goal of this clinical trial is to assess and compare the efficacy of two-year follow-up botulinum toxin type A （BTXA) in the treatment of acute acquired comitant esotropia (AACE) across five age groups: ≤6 years, >6 to ≤12 years, >12 to ≤20 years, >20 to ≤30 years, and >30 years. For patients >12 years presenting with large-angle esotropia (>50 PD), primary surgical intervention was recommended as the preferred approach to minimize failure and recurrence risk. Conversely, for patients ≤12 years, BTXA injection was maintained as the first-line treatment regardless of the deviation angle.
- Conditions
- Acute Acquired Comitant Esotropia
- Being tested
- Botulinum Toxin Type A Injection [Botox]
- Keywords
- Botulinum toxin, esotropia
- Medical subject headings
- Esotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A Injection [Botox]Procedure or surgery
for patients >12 years presenting with large-angle esotropia (>50 PD), primary surgical intervention was recommended as the preferred approach to minimize failure and recurrence risk. Conversely, for patients ≤12 years, BTXA injection was maintained as the first-line treatment regardless of the deviation angle.
| Study group | Role | What they receive |
|---|---|---|
| To assess and compare the long-term efficacy of botulinum toxin type A （BTXA) in the treatment of ac | Other | Not described Receives: Procedure: Botulinum Toxin Type A Injection [Botox] |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cumulative motor success rate
Kaplan-Meier survival analyses were conducted to evaluate the cumulative motor success rate.
A successful motor outcome was defined as achieving orthotropic alignment within 8 PD at both near (33 cm) and distance (6 m) fixation, accompanied by complete resolution of diplopia.
Measured: 2 years
Secondary outcomes (1)
the sensory success rate
The sensory success rate was calculated as the proportion of patients achieving successful sensory outcomes among all AACE patients receiving BTXA treatment, expressed as:
Sensory success rate = (Number of AACE patients with successful sensory outcomes post-BTXA) / (Total number of AACE patients treated with BTXA) × 100% Sensory success was defined as the restoration of stereopsis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jan 2019
- Primary completion1 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Acquired Comitant EsotropiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966999
- Sponsor's protocol ID
- 2017-073
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Botulinum Toxin Type A for Acute Acquired Comitant Esotropia: An Age-Stratified Two-Year Follow-Up Study
- ClinicalTrials.gov ID
- NCT06966999
- Acronym / sponsor ID
- 2017-073
- Conditions
- Acute Acquired Comitant Esotropia
- Keywords
- Botulinum toxin, esotropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 13 May 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 goal of this clinical trial is to assess and compare the efficacy of two-year follow-up botulinum toxin type A （BTXA) in the treatment of acute acquired comitant esotropia (AACE) across five age groups: ≤6 years, >6 to ≤12 years, >12 to ≤20 years, >20 to ≤30 years, and >30 years. For patients >12 years presenting with large-angle esotropia (>50 PD), primary surgical intervention was recommended as the preferred approach to minimize failure and recurrence risk. Conversely, for patients ≤12 years, BTXA injection was maintained as the first-line treatment regardless of the deviation angle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To assess and compare the long-term efficacy of botulinum toxin type A （BTXA) in the treatment of ac | Other | Procedure: Botulinum Toxin Type A Injection [Botox] |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of acute acquired comitant esotropia (AACE) with sudden onset and diplopia
- Normal eye movements with deviation difference ≤5 prism diopters (PD) in all gaze directions
- Hyperopia < +3.00 diopters
- <10 PD reduction in esotropia with hypermetropic spectacle correction
- No prior extraocular muscle surgery
Key exclusion criteria (4 listed)
- Deviation difference >5 PD in any gaze direction
- Hyperopia ≥ +3.00 diopters
- History of extraocular muscle surgery
- Presence of congenital/developmental anomalies potentially impacting outcomes
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 A Injection [Botox]for patients >12 years presenting with large-angle esotropia (>50 PD), primary surgical intervention was recommended as the preferred approach to minimize failure and recurrence risk. Conversely, for patients ≤12 years, BTXA injection was maintained as the first-line treatment regardless of the deviation angle. | Procedure or surgery | To assess and compare the long-term efficacy of botulinum toxin type A （BTXA) in the treatment of ac |
Primary outcome
the cumulative motor success rate
Time frame: 2 years
Kaplan-Meier survival analyses were conducted to evaluate the cumulative motor success rate. A successful motor outcome was defined as achieving orthotropic alignment within 8 PD at both near (33 cm) and distance (6 m) fixation, accompanied by complete resolution of diplopia.
1 secondary outcome
the sensory success rate
Time frame: 2 years
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 13 May 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A Injection [Botox] in people with Acute Acquired Comitant Esotropia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 6 inclusion and 4 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 13 May 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 China. 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?
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?
the cumulative motor success rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2025.