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

University of Toronto

Status and phase

Withdrawn

Phase 4

Conditions

Graves Ophthalmopathy

Treatments

Drug: Saline injection

Drug: Botulinum Toxin Type A

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01272414

10-0261-A

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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