A Phase 2/3 interventional study of Bupivacaine in Strabismus, Esotropia and Exotropia, sponsored by Smith-Kettlewell Eye Research Institute. Status unknown at 1 site in United States. Open to participants aged 8 Years to 95 Years. Per ClinicalTrials.gov, last updated 2019-09-23.
Sponsored by Smith-Kettlewell Eye Research Institute · Phase 2/3, Interventional, and Treatment
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.
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.
142 studies on the registry are indexed under Strabismus; 31 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 82 interventional studies indexed under Strabismus.
Browse Strabismus studies →Smith-Kettlewell Eye Research Institute is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Also known as: Marcaine
Eye alignment
Alignment of the two eyes as measured by prism cover test or other applicable test
Time frame: 6 months after injection
Percentage correction of the pre-treatment eye deviation
Time frame: 6 months after injection treatment
Plan to share: No
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Bupivacaine
Smith-Kettlewell Eye Research Institute