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NCT01616108 Clinical Trial

Bupivacaine Injection of Eye Muscles to Treat Strabismus

Strabismus Clinical Trial

Official title:
Bupivacaine Injection of Eye Muscles to Treat Strabismus

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01616108
Other study ID # BPX-STRAB
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date April 2012
Est. completion date September 2020

Study information
Verified date September 2019
Source Smith-Kettlewell Eye Research Institute
Contact Alan B Scott, MD
Phone 415 923 3120
Email abs@srfsf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date September 2020
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 8 Years to 95 Years
Eligibility Inclusion Criteria:

- Clinical pattern of strabismus of 5 prism diopters or more

Exclusion Criteria:

- Active eye infection

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Strabismus Research Foundation San Francisco California

Sponsors (4)
Lead Sponsor Collaborator
Smith-Kettlewell Eye Research Institute Eidactics, Strabismus Research Foundation, Sutter Health

Country where clinical trial is conducted

United States, 

References & Publications (5)

Debert I, Miller JM, Danh KK, Scott AB. Pharmacologic injection treatment of comitant strabismus. J AAPOS. 2016 Apr;20(2):106-111.e2. doi: 10.1016/j.jaapos.2015.11.011. — View Citation

Miller JM, Scott AB, Danh KK, Strasser D, Sane M. Bupivacaine injection remodels extraocular muscles and corrects comitant strabismus. Ophthalmology. 2013 Dec;120(12):2733-2740. doi: 10.1016/j.ophtha.2013.06.003. Epub 2013 Aug 2. — View Citation

Scott AB, Alexander DE, Miller JM. Bupivacaine injection of eye muscles to treat strabismus. Br J Ophthalmol. 2007 Feb;91(2):146-8. Epub 2006 Nov 29. — View Citation

Scott AB, Miller JM, Shieh KR. Bupivacaine injection of the lateral rectus muscle to treat esotropia. J AAPOS. 2009 Apr;13(2):119-22. doi: 10.1016/j.jaapos.2008.10.016. — View Citation

Scott AB, Miller JM, Shieh KR. Treating strabismus by injecting the agonist muscle with bupivacaine and the antagonist with botulinum toxin. Trans Am Ophthalmol Soc. 2009 Dec;107:104-9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Eye alignment Alignment of the two eyes as measured by prism cover test or other applicable test 6 months after injection
Secondary Percentage correction of the pre-treatment eye deviation 6 months after injection treatment
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