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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01272414

Enrollment

Registered

2011-01-07

Start date

2011-01-31

Completion date

2012-02-29

Last updated

2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves Ophthalmopathy

Keywords

Eyelid retraction, Botulinum Toxins

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.

Interventions

DRUGBotulinum Toxin Type A

2-12 units in weekly 2u doses to effect

DRUGSaline injection

Injection of 0.4cc 0.9% normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Reduction in upper lid retraction (in mm)	4 month

Secondary

Measure	Time frame	Description
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026