Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction

Phase 4

Withdrawn

• Conditions: Graves Ophthalmopathy
• Interventions: Drug: Saline injection; Drug: Botulinum Toxin Type A

• Registration Number: NCT01272414
• Lead Sponsor: University of Toronto

Brief Summary

Currently there are few therapeutic options for the treatment of lid retraction secondary to thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable of creating a ptosis, that in the setting of TO can return the upper lid to a more physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent stage lid position. This investigation aims to examine the properties of this relationship.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study Start: 2011-01
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2012-01
• Study Completion: 2012-02
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Active stage thyroid orbitopathy, as determined by symptom onset of under 6 months.
• Upper eyelid retraction of 1mm or greater.
• Complaining of either significant ocular symptoms (despite appropriate use of ocular lubricants), or bothered by the cosmetic deformity associated with the eyelid retraction.

Exclusion Criteria

• Less than 18 years of age
• Age over 65 years
• Pregnant or nursing
• Known peripheral neuropathy or neuromuscular junction disorder
• Demonstrated allergy to BoTox
• Current infection over the injection site
• Are currently taking any of the following medications: aminoglycosides, penicillamine, quinine, and calcium channel blockers.
• Previous or concurrent prednisone therapy
• Undergone previous upper eyelid surgery
• Severe vision threatening TO

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline injection	Saline injection	Saline injection to levator complex
BoTox Treatment	Botulinum Toxin Type A	Subjects receive BoTox injection to levator complex

Primary Outcome Measures

Name	Time	Method
Reduction in upper lid retraction (in mm)	4 month

Secondary Outcome Measures

Name	Time	Method
Subjective improvement in lid retraction related dry eye symptoms	4 months	ocular surface disease index score
Subjective improvement in lid retraction related cosmesis	4 months	Graves Orbitopathy quality of life score

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada