Bupivacaine Injection of Eye Muscles to Treat Strabismus

Status Recruiting

Clinical Trial Summary

This study seeks to determine if bupivacaine injection of eye muscles can make them stronger and stiffer, and thereby correct the position of eyes that are turned in or mis-aligned, a condition generally termed strabismus. It seeks further to find out the different effects of various concentrations or formulations of bupivacaine, and whether addition of Botox to other eye muscles can add to the effect of bupivacaine and enhance the correction of strabismus.

Clinical Trial Description

Patients eligible for inclusion in the study will be age 8 to 95 years and have an eye deviation (strabismus) that is potentially subject to surgical correction.

The eye alignment will be measured. The eye muscles may be measured by MRI. The eye will be anesthetized by eye drops. One or more eye muscles will be injected with bupivacaine. Botox® will be injected into the antagonist muscle in some cases to increase the effect of the bupivacaine.

Data on the strabismus deviation, any side effects of the drug injection, and the eye muscles as measured by MRI, will be recorded at intervals after injection. These data will be compared with the like measurements taken before injection.

The primary outcome will be the eye alignment change at 180 days. A secondary outcome will be the change in muscle size, strength, or stiffness.

For large strabismus deviations not fully corrected by a first injection, a second injection can be made. Follow-up alignment and muscle measurements will be as for the initial injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01616108
Study type	Interventional
Source	Smith-Kettlewell Eye Research Institute
Contact	Alan B Scott, MD
Phone	415 923 3120
Email	abs@srfsf.org
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	April 2012
Completion date	September 2020

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