Recruiting

Phase 2

Phase 3

BupivacaineBupivacaine Injection of Eye Muscles to Treat Strabismus

Sponsor:

Smith-Kettlewell Eye Research Institute

Code:

NCT01616108

Conditions

Strabismus

Esotropia

Exotropia

Graves Disease

Ptosis, Eyelid

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine

Study Details

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.

Conditions

Strabismus

Esotropia

Exotropia

Graves Disease

Ptosis, Eyelid

Study ID

NCT01616108

Start date

Apr, 2012

Status verified date

Sep, 2019

Completion date

Sep, 2020

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Clinical pattern of strabismus of 5 prism diopters or more

Exclusion Criteria:

Active eye infection

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Bupivacaine

Primary outcome measure

Eye alignment [ Time Frame: 6 months after injection ]

Central Contacts and Locations

Central contacts

Alan B Scott, MD

415 923 3120 abs@srfsf.org

Joel M Miller, PhD

415 672 0473 jmm@eidactics.com

Locations

Strabismus Research Foundation

Recruiting

San Francisco, California, United States, 94109

Contacts

ALAN B SCOTT, MD

415-509-2122 abs@srfsf.org

Principal Investigator:

ALAN B SCOTT, MD

More Information

Sponsor

Smith-Kettlewell Eye Research Institute

Last update posted

Sep 23, 2019

Last verified

Sep, 2019

Keywords

strabismus
diplopia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Smith-Kettlewell Eye Research Institute on 2019-09-23.