Bupivacaine Injection of Eye Muscles to Treat Strabismus

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Smith-Kettlewell Eye Research Institute
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Alan B. Scott, Smith-Kettlewell Eye Research Institute
ClinicalTrials.gov Identifier:
NCT01616108
First received: June 7, 2012
Last updated: December 17, 2012
Last verified: December 2012

June 7, 2012
December 17, 2012
April 2012
September 2013   (final data collection date for primary outcome measure)
Eye alignment [ Time Frame: 6 months after injection ] [ Designated as safety issue: No ]
Alignment of the two eyes as measured by prism cover test or other applicable test
Same as current
Complete list of historical versions of study NCT01616108 on ClinicalTrials.gov Archive Site
Percentage correction of the pre-treatment eye deviation [ Time Frame: 6 months after injection treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bupivacaine Injection of Eye Muscles to Treat Strabismus
Bupivacaine Injection of Eye Muscles to Treat Strabismus

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.

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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Strabismus
  • Esotropia
  • Exotropia
  • Graves Disease
  • Nystagmus
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 Name: Marcaine
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.
Intervention: Drug: Bupivacaine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical pattern of strabismus of 5 prism diopters or more

Exclusion Criteria:

  • Paralytic strabismus
  • Active eye infection
Both
8 Years to 95 Years
No
Contact: Alan Scott, MD 415 923 3120 abs@ski.org
Contact: Ken Danh, BS 415 345 2030 danh@ski.org
United States
 
NCT01616108
BPX-STRAB, 5R01EY018633-02
No
Alan B. Scott, Smith-Kettlewell Eye Research Institute
Smith-Kettlewell Eye Research Institute
  • National Institutes of Health (NIH)
  • National Eye Institute (NEI)
Principal Investigator: ALAN B SCOTT, MD Smith-Kettlewell Eye Research Institutue
Principal Investigator: JOEL M MILLER, PhD Smith-Kettlewell Eye Research Institute
Smith-Kettlewell Eye Research Institute
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP