Bupivacaine Injection of Eye Muscles to Treat Strabismus

This study is currently recruiting participants.

Verified December 2012 by Smith-Kettlewell Eye Research Institute

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Eye Institute (NEI)

Information provided by (Responsible Party):

Alan B. Scott, Smith-Kettlewell Eye Research Institute

ClinicalTrials.gov Identifier:

NCT01616108

First received: June 7, 2012

Last updated: December 17, 2012

Last verified: December 2012

History of Changes

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:	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:

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	September 2013 (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

Ages Eligible for Study:	8 Years to 95 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616108

Contacts

Contact: Alan Scott, MD	415 923 3120	abs@ski.org
Contact: Ken Danh, BS	415 345 2030	danh@ski.org

Locations

United States, California
Smith-Kettlewell Ey Research Institute	Recruiting
San Francisco, California, United States, 94115
Contact: ALAN B SCOTT, MD 415-923-3120 abs@ski.org
Principal Investigator: ALAN B SCOTT, MD

Sponsors and Collaborators

Smith-Kettlewell Eye Research Institute

National Institutes of Health (NIH)

National Eye Institute (NEI)

Investigators

Principal Investigator:	ALAN B SCOTT, MD	Smith-Kettlewell Eye Research Institutue
Principal Investigator:	JOEL M MILLER, PhD	Smith-Kettlewell Eye Research Institute

More Information

Publications:

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.

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, 5R01EY018633-02
Study First Received:	June 7, 2012
Last Updated:	December 17, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Smith-Kettlewell Eye Research Institute:

strabismus
diplopia

Additional relevant MeSH terms:

Esotropia
Exotropia
Graves Disease
Nystagmus, Pathologic
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Exophthalmos
Orbital Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases

Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

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