drugset / Trial / NCT01616108
Bupivacaine Injection of Eye Muscles to Treat Strabismus
Phase 2/3
Unknown
120 enrolled
Smith-Kettlewell Eye Research Institute
Eidactics · collabStrabismus Research Foundation · collabSutter Health · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-04
- Primary completion
- 2019-09
- Completion
- 2020-09
Publications
- Background 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.
- Background 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.
- Background Scott AB, Alexander DE, Miller JM. Bupivacaine injection of eye muscles to treat strabismus. Br J Ophthalmol. 2007 Feb;91(2):146-8. doi: 10.1136/bjo.2006.110619. Epub 2006 Nov 29.
- Background 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 0.75 % | Intramuscular |
| Subject | Bupivacaine | Other / unclassified | 1 ml | Intramuscular |
| Subject | Bupivacaine | Other / unclassified | 3 % | Intramuscular |
| Subject | Bupivacaine | Other / unclassified | 3 ml | Intramuscular |