Bupivacaine Injection of Eye Muscles to Treat Strabismus

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01616108

Enrollment

120

Registered

2012-06-11

Start date

2012-04-30

Completion date

2020-09-30

Last updated

2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

strabismus, diplopia

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.

Interventions

DRUGBupivacaine

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 95 Years

Healthy volunteers

Inclusion criteria

* Clinical pattern of strabismus of 5 prism diopters or more

Exclusion criteria

* Active eye infection

Design outcomes

Primary

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

Secondary

Measure	Time frame
Percentage correction of the pre-treatment eye deviation	6 months after injection treatment

Countries

United States

Contacts

Primary ContactAlan B Scott, MD

abs@srfsf.org415 923 3120

Backup ContactJoel M Miller, PhD

jmm@eidactics.com415 672 0473

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026