Bupivacaine Injection of Eye Muscles to Treat Strabismus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bupivacaine Injection 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. |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Eye alignment [6 months after injection]
Alignment of the two eyes as measured by prism cover test or other applicable test
Secondary Outcome Measures
- Percentage correction of the pre-treatment eye deviation [6 months after injection treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Clinical pattern of strabismus of 5 prism diopters or more
Exclusion Criteria:
- Active eye infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Strabismus Research Foundation | San Francisco | California | United States | 94109 |
Sponsors and Collaborators
- Smith-Kettlewell Eye Research Institute
- Eidactics
- Sutter Health
- Strabismus Research Foundation
Investigators
- Principal Investigator: Alan B Scott, MD, Strabismus Research Foundation
- Principal Investigator: Joel M Miller, PhD, Strabismus Research Foundation
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- BPX-STRAB