Bupivacaine Injection of Eye Muscles to Treat Strabismus

Phase 2

• Conditions: Strabismus; Esotropia; Exotropia; Graves Disease; Ptosis, Eyelid
• Interventions: Drug: Bupivacaine

• Registration Number: NCT01616108
• Lead Sponsor: Smith-Kettlewell Eye Research Institute

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 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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-11
• Status Verified: 2019-09
• Primary Completion: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Clinical pattern of strabismus of 5 prism diopters or more

Exclusion Criteria

• Active eye infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bupivacaine Injection	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.

Primary Outcome Measures

Name	Time	Method
Eye alignment	6 months after injection	Alignment of the two eyes as measured by prism cover test or other applicable test

Secondary Outcome Measures

Name	Time	Method
Percentage correction of the pre-treatment eye deviation	6 months after injection treatment

Trial Locations

Locations (1)

Strabismus Research Foundation; 🇺🇸 San Francisco, California, United States