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Bupivacaine Injection of Eye Muscles to Treat Strabismus

This study is currently recruiting participants.
Verified October 2016 by Alan B. Scott, Smith-Kettlewell Eye Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01616108
First Posted: June 11, 2012
Last Update Posted: October 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Eidactics
Sutter Health
Strabismus Research Foundation
Information provided by (Responsible Party):
Alan B. Scott, Smith-Kettlewell Eye Research Institute
  Purpose
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
Strabismus Esotropia Exotropia Graves Disease Nystagmus Drug: Bupivacaine Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bupivacaine Injection of Eye Muscles to Treat Strabismus

Resource links provided by NLM:


Further study details as provided by Alan B. Scott, Smith-Kettlewell Eye Research Institute:

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

Estimated Enrollment: 120
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.

  Eligibility

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
Criteria

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


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

Locations
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
Eidactics
Sutter Health
Strabismus Research Foundation
Investigators
Principal Investigator: Alan B Scott, MD Strabismus Research Foundation
Principal Investigator: Joel M Miller, PhD Eidactics
  More Information

Additional Information:
Publications:
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 Submitted: June 7, 2012
First Posted: June 11, 2012
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:
strabismus
diplopia

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


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