Clinical trial NCT01616108: Bupivacaine Injection of Eye Muscles to Treat Strabismus
Official title: Bupivacaine Injection of Eye Muscles to Treat Strabismus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Strabismus
Esotropia
Exotropia
Graves Disease
Ptosis, Eyelid
Keywords: strabismus
diplopia
Lead sponsor: Smith-Kettlewell Eye Research Institute
Sponsor class: OTHER
Collaborators: name: Eidactics
name: Sutter Health
name: Strabismus Research Foundation
First posted: 2012-06-11
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Clinical pattern of strabismus of 5 prism diopters or more

Exclusion Criteria:

* Active eye infection

Primary outcomes:
measure: Eye alignment
timeFrame: 6 months after injection
Secondary outcomes:
measure: Percentage correction of the pre-treatment eye deviation
timeFrame: 6 months after injection treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Strabismus Research Foundation
state: California
Study officials:
affiliation: Strabismus Research Foundation
name: Alan B Scott, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Strabismus Research Foundation
name: Joel M Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: 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.
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.