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Not yet recruitingNCT06714877Updated Dec 5, 2024

Botulinum Toxin Injection Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia

An interventional study of prism treatment group and botulinum toxin group in Esotropia, sponsored by Eye & ENT Hospital of Fudan University. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Esotropia

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Keywords

  • Acute Acquired Concomitant Esotropia
  • Treatment
  • Botulinum Toxin Injection
03

In context

Esotropia

34 studies on the registry are indexed under Esotropia; 11 are open to participants now.

This study's planned enrollment of 100 is above the median of 71 across 22 interventional studies indexed under Esotropia.

Browse Esotropia studies →

Lead sponsor

Eye & ENT Hospital of Fudan University is the lead sponsor of 124 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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)
  2. strabismus angle ≤ 25PD
  3. best corrected visual acuity of both eyes ≥ 1.0
  4. intracranial disease is excluded by cranial CT or magnetic resonance imaging

Exclusion criteria

Exclusion Criteria:

  1. reduction of strabismus angle by more than 10 prism diopters after refractive correction
  2. history of other ocular diseases or ocular surgeries
  3. presence of organic brain lesions or systemic diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    prism treatment group

    prism treatment

    Other: prism treatment group

  • Experimental
    botulinum toxin group

    botulinum toxin injection

    Procedure: botulinum toxin group

Interventions

  • Otherprism treatment group

    wearing prism glasses

  • Procedurebotulinum toxin group

    botulinum toxin injection

06

What researchers measure

Primary outcomes

  1. strabismus angle

    using prism cover test to evaluate the reduction of strabismus angle

    Time frame: 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

    Time frame: Before treatment, 1 week, 1 month, 3 months, 6 months after treatment

07

Study locations

1 site
  • Eye & ENT Hospital of Fudan University
    Shanghai, China, China
    • Wen Wen, MD, PhD · Contact · wenweneye@126.com · 86+(021)34233133
    • Wen Wen, MD, PhD · Contact
    • Shuyang Guo, MD · Contact
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References and documents

Individual participant data

Plan to share: No — We concerns about patient privacy issues and it's better to protect the publication potential.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2024; primary completion for Sep 2025, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2024
First posted
Dec 4, 2024
StartEst.
Dec 10, 2024
Primary completionEst.
Sep 30, 2025
CompletionEst.
Dec 10, 2026
Last update
Dec 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06714877
Responsible party
Sponsor
First posted
Dec 4, 2024
Start date
Dec 10, 2024 (estimated)
Primary completion
Sep 30, 2025 (estimated)
Completion
Dec 10, 2026 (estimated)
Last update
Dec 5, 2024

Study contacts

Wen Wen, MD, PhD
Contact
wenweneye@126.com
+86 (21) 3423 3133
Shuyang Guo, MD
Contact
m15880091363@163.com
Wen Wen, MD, PhD
study chair · Eye & ENT Hospital of Fudan University, Shanghai, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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