Surgery for Esotropia Under Topical Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2013-06-30

Brief Summary

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Adult patients requiring surgery for esotropia will be randomized to surgery under topical anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic procedures will be compared. Motor and sensory outcome of the two treatment groups will also be compared.

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Detailed Description

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Conditions

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Esotropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Topical anesthesia

Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel)

Group Type EXPERIMENTAL

Topical strabismus surgery

Intervention Type PROCEDURE

Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure

Sub-Tenon's anesthesia

Patients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine)

Group Type ACTIVE_COMPARATOR

Sub-Tenon's strabismus surgery

Intervention Type PROCEDURE

Surgery is carried out after sub-Tenon's injection of xylocaine

Interventions

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Topical strabismus surgery

Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure

Intervention Type PROCEDURE

Sub-Tenon's strabismus surgery

Surgery is carried out after sub-Tenon's injection of xylocaine

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Esotropia deviation angle equal to or lower than 45 prism dioptres (requiring one or two-muscle surgery)
* Visual acuity at least 20/40 in each eye
* Cooperation for topical anesthesia