Clinical Trial: Bupivacaine Injection of Eye Muscles to Treat Strabismus

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Bupivacaine Injection of Eye Muscles to Treat Strabismus

Brief 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.

Detailed Summary:

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 will 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.


Sponsor: Smith-Kettlewell Eye Research Institute

Current Primary Outcome: Eye alignment [ Time Frame: 6 months after injection ]

Alignment of the two eyes as measured by prism cover test or other applicable test


Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage correction of the pre-treatment eye deviation [ Time Frame: 6 months after injection treatment ]

Original Secondary Outcome: Same as current

Information By: Smith-Kettlewell Eye Research Institute

Dates:
Date Received: June 7, 2012
Date Started: April 2012
Date Completion: September 2020
Last Updated: October 13, 2016
Last Verified: October 2016