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Bupivacaine Injection of Eye Muscles to Treat Strabismus

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ClinicalTrials.gov Identifier: NCT01616108
Recruitment Status : Recruiting
First Posted : June 11, 2012
Last Update Posted : October 14, 2016
Information provided by (Responsible Party):

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
Strabismus Esotropia Exotropia Graves Disease Nystagmus Drug: Bupivacaine 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 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bupivacaine Injection of Eye Muscles to Treat Strabismus
Study Start Date : April 2012
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

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 Name: Marcaine

Outcome Measures

Primary Outcome Measures :
  1. Eye alignment [ Time Frame: 6 months after injection ]
    Alignment of the two eyes as measured by prism cover test or other applicable test

Secondary Outcome Measures :
  1. Percentage correction of the pre-treatment eye deviation [ Time Frame: 6 months after injection treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 95 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616108

Contact: Alan B Scott, MD 415 923 3120 abs@srfsf.org
Contact: Joel M Miller, PhD 858 220 2226 kkd@srfsf.org

United States, California
Strabismus Research Foundation Recruiting
San Francisco, California, United States, 94109
Contact: ALAN B SCOTT, MD    415-509-2122    abs@srfsf.org   
Principal Investigator: ALAN B SCOTT, MD         
Sponsors and Collaborators
Smith-Kettlewell Eye Research Institute
Sutter Health
Strabismus Research Foundation
Principal Investigator: Alan B Scott, MD Strabismus Research Foundation
Principal Investigator: Joel M Miller, PhD Eidactics
More Information

Additional Information:
Responsible Party: Alan B. Scott, Senior Scientist, Smith-Kettlewell Eye Research Institute
ClinicalTrials.gov Identifier: NCT01616108     History of Changes
Other Study ID Numbers: BPX-STRAB
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alan B. Scott, Smith-Kettlewell Eye Research Institute:

Additional relevant MeSH terms:
Graves Disease
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Orbital Diseases
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents