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Bupivacaine Injection of Eye Muscles to Treat Strabismus

Information source: Smith-Kettlewell Eye Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Strabismus; Esotropia; Exotropia; Graves Disease; Nystagmus

Intervention: Bupivacaine (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Smith-Kettlewell Eye Research Institute

Official(s) and/or principal investigator(s):
Alan B Scott, MD, Principal Investigator, Affiliation: Strabismus Research Foundation
Joel M Miller, PhD, Principal Investigator, Affiliation: Eidactics

Overall contact:
Alan Scott, MD, Phone: 415 923 3120, Email: abs@srfsf.org


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 Details

Official title: Bupivacaine Injection of Eye Muscles to Treat Strabismus

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Eye alignment

Secondary outcome: Percentage correction of the pre-treatment eye deviation

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 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.


Minimum age: 8 Years. Maximum age: 95 Years. Gender(s): Both.


Inclusion Criteria:

- Clinical pattern of strabismus of 5 prism diopters or more

Exclusion Criteria:

- Paralytic strabismus

- Active eye infection

Locations and Contacts

Alan Scott, MD, Phone: 415 923 3120, Email: abs@srfsf.org

Smith-Kettlewell Ey Research Institute, San Francisco, California 94115, United States; Recruiting
ALAN B SCOTT, MD, Phone: 415-923-3120, Email: abs@ski.org
ALAN B SCOTT, MD, Principal Investigator
Additional Information

Starting date: April 2012
Last updated: February 2, 2015

Page last updated: August 23, 2015

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