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Bupivacaine Injection of Eye Muscles to Treat Strabismus

NCT01616108 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-09-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Eidactics

    collaborator OTHER

  • Sutter Health

    collaborator OTHER

  • Strabismus Research Foundation

    collaborator OTHER

  • Smith-Kettlewell Eye Research Institute

    lead OTHER

Principal Investigators

  • Alan B Scott, MD · Strabismus Research Foundation

  • Joel M Miller, PhD · Strabismus Research Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2019-09-30
Completion
2020-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01616108 on ClinicalTrials.gov