NCT01616108

Bupivacaine Injection of Eye Muscles to Treat Strabismus

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Smith-Kettlewell Eye Research Institute · Academic / Other
• Sex: All
• Age: 8 Years – 95 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Strabismus
• Esotropia
• Exotropia
• Graves Disease
• Ptosis, Eyelid

Interventions

Type	Name	Description
DRUG	Bupivacaine	Differences in concentration from 0.75% to 3.0% are compared. Differences in volume for 1.0 mL to 3.0 mL are compared. Differences in compounding with addition of epinephrine will be used and compared to plain bupivacaine.

Timeline

• Start date: 2012-04-01
• Primary completion: 2019-09-01
• Completion: 2020-09-01
• First posted: 2012-06-11
• Last updated: 2019-09-23

Locations

1 site across 1 country: United States