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Bupivacaine Injection of Eye Muscles to Treat Strabismus

Primary Purpose

Strabismus, Esotropia, Exotropia

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bupivacaine

About this trial

This is an interventional treatment trial for Strabismus focused on measuring strabismus, diplopia

Eligibility Criteria

8 Years - 95 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical pattern of strabismus of 5 prism diopters or more

Exclusion Criteria:

Active eye infection

Sites / Locations

Strabismus Research FoundationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bupivacaine Injection

Arm Description

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.

Outcomes

Primary Outcome Measures

Eye alignment

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

Full Information

NCT ID

NCT01616108

First Posted

June 7, 2012

Last Updated

September 19, 2019

Sponsor

Smith-Kettlewell Eye Research Institute

Collaborators

Eidactics, Sutter Health, Strabismus Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01616108

Brief Title

Bupivacaine Injection of Eye Muscles to Treat Strabismus

Official Title

Bupivacaine Injection of Eye Muscles to Treat Strabismus

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 2012 (undefined)

Primary Completion Date

September 2019 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Smith-Kettlewell Eye Research Institute

Collaborators

Eidactics, Sutter Health, Strabismus Research Foundation

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Strabismus, Esotropia, Exotropia, Graves Disease, Ptosis, Eyelid

Keywords

strabismus, diplopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bupivacaine Injection

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Marcaine

Intervention Description

Primary Outcome Measure Information:

Title

Eye alignment

Description

Alignment of the two eyes as measured by prism cover test or other applicable test

Time Frame

6 months after injection

Secondary Outcome Measure Information:

Title

Percentage correction of the pre-treatment eye deviation

Time Frame

6 months after injection treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical pattern of strabismus of 5 prism diopters or more Exclusion Criteria: Active eye infection

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alan B Scott, MD

Phone

415 923 3120

abs@srfsf.org

First Name & Middle Initial & Last Name or Official Title & Degree

Joel M Miller, PhD

Phone

415 672 0473

jmm@eidactics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan B Scott, MD

Organizational Affiliation

Strabismus Research Foundation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joel M Miller, PhD

Organizational Affiliation

Strabismus Research Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Strabismus Research Foundation

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ALAN B SCOTT, MD

Phone

415-509-2122

abs@srfsf.org

First Name & Middle Initial & Last Name & Degree

ALAN B SCOTT, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23916485

Citation

Miller JM, Scott AB, Danh KK, Strasser D, Sane M. Bupivacaine injection remodels extraocular muscles and corrects comitant strabismus. Ophthalmology. 2013 Dec;120(12):2733-2740. doi: 10.1016/j.ophtha.2013.06.003. Epub 2013 Aug 2.

Results Reference

background

PubMed Identifier

19393509

Citation

Scott AB, Miller JM, Shieh KR. Bupivacaine injection of the lateral rectus muscle to treat esotropia. J AAPOS. 2009 Apr;13(2):119-22. doi: 10.1016/j.jaapos.2008.10.016.

Results Reference

background

PubMed Identifier

17135337

Citation

Scott AB, Alexander DE, Miller JM. Bupivacaine injection of eye muscles to treat strabismus. Br J Ophthalmol. 2007 Feb;91(2):146-8. doi: 10.1136/bjo.2006.110619. Epub 2006 Nov 29.

Results Reference

background

PubMed Identifier

27079589

Citation

Debert I, Miller JM, Danh KK, Scott AB. Pharmacologic injection treatment of comitant strabismus. J AAPOS. 2016 Apr;20(2):106-111.e2. doi: 10.1016/j.jaapos.2015.11.011.

Results Reference

background

PubMed Identifier

20126486

Citation

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.

Results Reference

result

Links:

URL

http://www.srfsf.org

Description

Homepage for The Strabismus Research Foundation.

Learn more about this trial

Bupivacaine Injection of Eye Muscles to Treat Strabismus

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