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

University of Toronto

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Graves Ophthalmopathy

Interventions

Botulinum Toxin Type ADRUG

2-12 units in weekly 2u doses to effect

Saline injectionDRUG

Injection of 0.4cc 0.9% normal saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Reduction in upper lid retraction (in mm)

Time frame: 4 month

Secondary Outcomes

Subjective improvement in lid retraction related dry eye symptoms

ocular surface disease index score

Time frame: 4 months

Subjective improvement in lid retraction related cosmesis

Graves Orbitopathy quality of life score

Time frame: 4 months

Data from ClinicalTrials.gov

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