EsotropiaNCT06714877
Botulinum Toxin Injection Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia
A study testing prism treatment group and botulinum toxin group in people with Esotropia, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
This is a single-center, prospective, randomized controlled trial evaluating type A botulinum toxin injection and prism therapy for the treatment of small-angle acute acquired concomitant esotropia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esotropia
- What is being tested?
- prism treatment group and botulinum toxin group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 10 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- acute acquired concomitant esotropia diagnosis (sudden onset of esotropia or diplopia, no significant change in the degree of strabismus in each eye position, and no limitation in eye movement)
- strabismus angle ≤ 25PD
- best corrected visual acuity of both eyes ≥ 1.0
- intracranial disease is excluded by cranial CT or magnetic resonance imaging
Who cannot join
- reduction of strabismus angle by more than 10 prism diopters after refractive correction
- history of other ocular diseases or ocular surgeries
- presence of organic brain lesions or systemic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shuyang Guo, MD contact
China1 site
Eye & ENT Hospital of Fudan University
Shanghai, China
Wen Wen, MD, PhD, 86+(021)34233133, wenweneye@126.com
Wen Wen, MD, PhD
About this study
Official title: A Single-center, Prospective, Randomized Controlled Trial Evaluating Type a Botulinum Toxin Injection and Prism Therapy for the Treatment of Acute Acquired Concomitant Esotropia
This is a single-center, prospective, randomized controlled trial evaluating type A botulinum toxin injection and prism therapy for the treatment of small-angle acute acquired concomitant esotropia.
Specific Aim 1 (Primary): To compare the reduction of deviation angle and improvement of diplopia symptoms between botulinum toxin injection and prism therapy for the treatment of small-angle acute acquired concomitant esotropia.
Specific Aim 2 (Secondary): To compare the improvement of visual functions between botulinum toxin injection and prism therapy for the treatment of small-angle acute acquired concomitant esotropia.
Read the detailed description
Acute acquired concomitant esotropia (AACE) belongs to the category of concomitant strabismus, which manifests as sudden onset, often accompanied by diplopia, and no change in the strabismus angle of each eye position. In recent years, with the increase in the use of smartphones and other screen devices, the incidence of AACE has been on the rise. Commonly used treatments in clinical practice include surgical treatment, botulinum toxin injection, and prism treatment. Patients with large deviation angel generally require surgical intervention to fundamentally correct their eye position and eliminate diplopia, but surgical treatment requires waiting for six months and can only be performed after the patient's strabismus degree is stable, and there is a risk of intraoperative trauma and secondary surgery. Patients with early and small-angle strabismus often choose prism treatment.
The principle of prism treatment is light refraction. After the light is refracted through the prism, it falls on the fovea of the strabismic eye, eliminating diplopia. In the treatment of AACE, the main target population of prisms is patients with mild strabismus (the strabismus angle is usually less than 25 PD. Wearing prisms can eliminate diplopia and relieve related symptoms, but it does not really correct the patient's strabismus problem.
Botulinum toxin treatment is to inject botulinum toxin type A into the medial rectus muscle to weaken the muscle strength and improve strabismus. Although it has not been widely used in clinical practice, a large number of studies have compared the efficacy of botulinum toxin treatment and surgical treatment. Some studies have found that the efficacy of the two is equivalent, which indicates that botulinum toxin treatment may be a good treatment option for AACE. Botulinum toxin treatment has the advantages of simple operation, low patient cooperation requirements, fast recovery, low trauma, and low treatment cost. It may become a treatment option for patients with small angle AACE. There are also reports that temporary ptosis and overcorrection may occur after botulinum toxin injection. The safety of botulinum toxin injection treatment also needs to be explored. However, existing studies have not fully explored the effectiveness and safety of botulinum toxin in the treatment of small-angle AACE, nor have studies compared the therapeutic effects of prisms and botulinum toxin on small-angle AACE.
In order to better guide clinical practice, we conducted this prospective cohort study to objectively evaluate and compare the therapeutic effects of botulinum toxin and prism treatment on AACE. It is expected that the results of the study will provide more treatment options for AACE patients and provide important guidance for the clinical selection of appropriate methods to treat small-angle AACE.
- Conditions
- Esotropia
- Being tested
- prism treatment group, botulinum toxin group
- Keywords
- Acute Acquired Concomitant Esotropia, Treatment, Botulinum Toxin Injection
- Medical subject headings
- Esotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prism treatment groupOther
wearing prism glasses
botulinum toxin groupProcedure or surgery
botulinum toxin injection
| Study group | Role | What they receive |
|---|---|---|
| prism treatment group | Active comparator | prism treatment Receives: Other: prism treatment group |
| botulinum toxin group | Experimental | botulinum toxin injection Receives: Procedure: botulinum toxin group |
What is being measured
The primary outcome is the main question the study is designed to answer.
strabismus angle
using prism cover test to evaluate the reduction of strabismus angle
Measured: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
Secondary outcomes (1)
stereopsis
using randot stereotest to evaluate the improvement of stereopsis
Measured: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsotropiaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Wen, MD, PhD, Study chair, Eye & ENT Hospital of Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714877
- Sponsor's protocol ID
- 2024-BTXAACE
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We concerns about patient privacy issues and it's better to protect the publication potential.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Randomized Controlled Trial Evaluating Type a Botulinum Toxin Injection and Prism Therapy for the Treatment of Acute Acquired Concomitant Esotropia
- ClinicalTrials.gov ID
- NCT06714877
- Acronym / sponsor ID
- 2024-BTXAACE
- Conditions
- Esotropia
- Keywords
- Acute Acquired Concomitant Esotropia, Treatment, Botulinum Toxin Injection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 4 Dec 2024 (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.
This is a single-center, prospective, randomized controlled trial evaluating type A botulinum toxin injection and prism therapy for the treatment of small-angle acute acquired concomitant esotropia.
Specific Aim 1 (Primary): To compare the reduction of deviation angle and improvement of diplopia symptoms between botulinum toxin injection and prism therapy for the treatment of small-angle acute acquired concomitant esotropia.
Specific Aim 2 (Secondary): To compare the improvement of visual functions between botulinum toxin injection and prism therapy for the treatment of small-angle acute acquired concomitant esotropia.
Detailed description
Acute acquired concomitant esotropia (AACE) belongs to the category of concomitant strabismus, which manifests as sudden onset, often accompanied by diplopia, and no change in the strabismus angle of each eye position. In recent years, with the increase in the use of smartphones and other screen devices, the incidence of AACE has been on the rise. Commonly used treatments in clinical practice include surgical treatment, botulinum toxin injection, and prism treatment. Patients with large deviation angel generally require surgical intervention to fundamentally correct their eye position and eliminate diplopia, but surgical treatment requires waiting for six months and can only be performed after the patient's strabismus degree is stable, and there is a risk of intraoperative trauma and secondary surgery. Patients with early and small-angle strabismus often choose prism treatment.
The principle of prism treatment is light refraction. After the light is refracted through the prism, it falls on the fovea of the strabismic eye, eliminating diplopia. In the treatment of AACE, the main target population of prisms is patients with mild strabismus (the strabismus angle is usually less than 25 PD. Wearing prisms can eliminate diplopia and relieve related symptoms, but it does not really correct the patient's strabismus problem.
Botulinum toxin treatment is to inject botulinum toxin type A into the medial rectus muscle to weaken the muscle strength and improve strabismus. Although it has not been widely used in clinical practice, a large number of studies have compared the efficacy of botulinum toxin treatment and surgical treatment. Some studies have found that the efficacy of the two is equivalent, which indicates that botulinum toxin treatment may be a good treatment option for AACE. Botulinum toxin treatment has the advantages of simple operation, low patient cooperation requirements, fast recovery, low trauma, and low treatment cost. It may become a treatment option for patients with small angle AACE. There are also reports that temporary ptosis and overcorrection may occur after botulinum toxin injection. The safety of botulinum toxin injection treatment also needs to be explored. However, existing studies have not fully explored the effectiveness and safety of botulinum toxin in the treatment of small-angle AACE, nor have studies compared the therapeutic effects of prisms and botulinum toxin on small-angle AACE.
In order to better guide clinical practice, we conducted this prospective cohort study to objectively evaluate and compare the therapeutic effects of botulinum toxin and prism treatment on AACE. It is expected that the results of the study will provide more treatment options for AACE patients and provide important guidance for the clinical selection of appropriate methods to treat small-angle AACE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prism treatment group | Active comparator | Other: prism treatment groupprism treatment |
| botulinum toxin group | Experimental | Procedure: botulinum toxin groupbotulinum toxin injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- acute acquired concomitant esotropia diagnosis (sudden onset of esotropia or diplopia, no significant change in the degree of strabismus in each eye position, and no limitation in eye movement)
- strabismus angle ≤ 25PD
- best corrected visual acuity of both eyes ≥ 1.0
- intracranial disease is excluded by cranial CT or magnetic resonance imaging
Key exclusion criteria (3 listed)
- reduction of strabismus angle by more than 10 prism diopters after refractive correction
- history of other ocular diseases or ocular surgeries
- presence of organic brain lesions or systemic diseases
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 |
|---|---|---|
| prism treatment groupwearing prism glasses | Other | prism treatment group |
| botulinum toxin groupbotulinum toxin injection | Procedure or surgery | botulinum toxin group |
Primary outcome
strabismus angle
Time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
using prism cover test to evaluate the reduction of strabismus angle
1 secondary outcome
stereopsis
Time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
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 5 Dec 2024.
- Individual participant dataSharing planned: No. We concerns about patient privacy issues and it's better to protect the publication potential.
Related trials for Esotropia
Active, not recruitingObservational study
An Observational Cohort Study to Explore the Clinical Outcome of Congenital Strabismmus Based on Etiology and Timing of Surgery
Congenital Esotropia
RecruitingObservational study
Eye-Hand Cross-Dominance and Upper Extremity Performance in Volleyball Players
Volleyball Player
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Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia
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Not yet recruiting
Visual Therapy for Intermittent Strabismus
Intermittent Strabismus, Exotropia Intermittent
Not yet recruitingPhase 3
A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD
Esotropia
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.
Shuyang Guo, MD contact
Wen Wen, MD, PhD study chair
Eye & ENT Hospital of Fudan University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prism treatment group and botulinum toxin group in people with Esotropia, run by Eye & ENT Hospital of Fudan University 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 4 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 5 Dec 2024. 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?
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 Wen Wen, MD, PhD (+86 (21) 3423 3133, wenweneye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
strabismus angle (time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment). 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 5 Dec 2024.