Trial record 3 of 5 for:    Open Studies | "Nystagmus, Pathologic"

Bupivacaine Injection of Eye Muscles to Treat Strabismus

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Smith-Kettlewell Eye Research Institute
Sutter Health
Information provided by (Responsible Party):
Alan B. Scott, Smith-Kettlewell Eye Research Institute Identifier:
First received: June 7, 2012
Last updated: February 2, 2015
Last verified: February 2015

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 Intervention Phase
Graves Disease
Drug: Bupivacaine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bupivacaine Injection of Eye Muscles to Treat Strabismus

Resource links provided by NLM:

Further study details as provided by Smith-Kettlewell Eye Research Institute:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Percentage correction of the pre-treatment eye deviation [ Time Frame: 6 months after injection treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Marcaine

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 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.


Ages Eligible for Study:   8 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical pattern of strabismus of 5 prism diopters or more

Exclusion Criteria:

  • Paralytic strabismus
  • Active eye infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01616108

Contact: Alan Scott, MD 415 923 3120
Contact: Kenneth Danh, BS 858 220 2226

United States, California
Smith-Kettlewell Ey Research Institute Recruiting
San Francisco, California, United States, 94115
Contact: ALAN B SCOTT, MD    415-923-3120   
Principal Investigator: ALAN B SCOTT, MD         
Sponsors and Collaborators
Smith-Kettlewell Eye Research Institute
Sutter Health
Principal Investigator: Alan B Scott, MD Strabismus Research Foundation
Principal Investigator: Joel M Miller, PhD Eidactics
  More Information

Responsible Party: Alan B. Scott, Senior Scientist, Smith-Kettlewell Eye Research Institute Identifier: NCT01616108     History of Changes
Other Study ID Numbers: BPX-STRAB
Study First Received: June 7, 2012
Last Updated: February 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Smith-Kettlewell Eye Research Institute:

Additional relevant MeSH terms:
Graves Disease
Autoimmune Diseases
Cranial Nerve Diseases
Endocrine System Diseases
Eye Diseases
Immune System Diseases
Nervous System Diseases
Ocular Motility Disorders
Orbital Diseases
Thyroid Diseases
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on October 09, 2015