Bupivacaine Injection of Eye Muscles to Treat Strabismus

September 19, 2019 updated by: Alan B. Scott, Smith-Kettlewell Eye Research Institute
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
        • Recruiting
        • Strabismus Research Foundation
        • Contact:
          • ALAN B SCOTT, MD
          • Phone Number: 415-509-2122
          • Email: abs@srfsf.org
        • Principal Investigator:
          • ALAN B SCOTT, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 95 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical pattern of strabismus of 5 prism diopters or more

Exclusion Criteria:

  • Active eye infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eye alignment
Time Frame: 6 months after injection
Alignment of the two eyes as measured by prism cover test or other applicable test
6 months after injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage correction of the pre-treatment eye deviation
Time Frame: 6 months after injection treatment
6 months after injection treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith-Kettlewell Eye Research Institute

Collaborators

Eidactics
Sutter Health
Strabismus Research Foundation

Investigators

  • Principal Investigator: Alan B Scott, MD, Strabismus Research Foundation
  • Principal Investigator: Joel M Miller, PhD, Strabismus Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPX-STRAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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