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

ConditionEsotropia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEye & ENT Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • prism treatment group

    Other intervention

    wearing prism glasses

  • botulinum toxin group

    Procedure/Surgery

    botulinum toxin injection

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: prism treatment groupActive comparator 1 intervention
Group B: botulinum toxin groupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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