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Injection versus Surgery for esotropia in infants

Outcome of Botulinum injection vs early surgery in Infantile esotropia: A prospective randomized comparative study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038205
Enrollment
30
Registered
2021-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H500- Esotropia

Interventions

Intervention1: Botulinum toxin injection: PREPARATION OF BOTOX INJECTOIN 1ml normal saline is mixed with 50IU botulinum injection in order to prepare 5IU/0.1ml. DOSAGE Botox injection from 2.5 IU I t
4IU-esotropia 35-40pd
5IU-esotropia 45-50pd
6IU-esotropia 50-60pd
7-7.5 IU-esotropia 60pd MODE OF ADMINISTRATION INJECTION Both injection and surgery will be performed under general anesthesia (laryngeal mask). Proper perioperative pain management and social suppor

Sponsors

Post Graduate of Medical Sciences and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. esotropia consistent with the diagnosis of Infantile Esotropia ii. Constant deviation of 20 prism dioptres (PD) or more iii. Age

Exclusion criteria

Exclusion criteria: 1. Horizontal muscle surgery performed prior to treatment. 2.Persistent severe amblyopia in one eye. 3. significant developmental delay or neurologic abnormalities 4. accommodative esotropia 5. oblique muscle overaction, presence of nystagmus, and dissociated deviations nystagmus 6.Fixation preference/ amblyopia 7. presence of vertical deviation 8. Children with previous or anticipated airway problems 9. Known drug sensitivity 10. Denial of parents to give consent for the study protocol

Design outcomes

Primary

MeasureTime frame
Comparison of percentage of success in botulinum toxin group with percentage success in early surgery groupTimepoint: 1week,1month,3months and 6months

Secondary

MeasureTime frame
1.Occurrence of timing of development of associated findings (eg dissociated vertical Deviation, superior oblique overaction, Inferior oblique overaction, A- V pattern present pre-operatively or develop during follow up) 2. Analysis of factors resulting in failure of botox injection Timepoint: 6 months follow-up from last intervention

Countries

India

Contacts

Public ContactShweta Chaurasia

PGIMER

shweta84omns@yahoo.com9990909575

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026