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