Treatment of Upper Eyelid Retraction Related to Thyroid-associated Ophthalmopathy Using Subconjunctival Triamcinolone Injections
Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thyroid-associated Ophthalmopathy
Intervention: subconjunctival triamcinolone injection (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Yonsei University
Summary
Thyroid-associated ophthalmopathy (TAO) is an autoimmune process that can affect the orbital
and periorbital tissues and the thyroid gland. Periorbital inflammation can cause swelling,
fatty infiltration, and scarring of the eyelid muscles resulting in eyelid retraction and
upper scleral exposure, which is the most common clinical features of TAO. Even with mild
eyelid retraction and swelling, most patients become disappointed and depressed due to their
cosmetically unacceptable appearance, and they are unwilling to wait for spontaneous
resolution or a clinically inactive period for surgical intervention. Thus, most
ophthalmologists and endocrinologists recommend surgery in the chronic burnt-out stage.
Several treatment options have been described for correction of eyelid retraction, including
Botox and filler injection, and surgeries in the burnt-out stage such as lowering the upper
lid by recessing the levator muscle, excision of Müller's muscle, introducing a spacer, or
myotomies. Surgical options have significant risks as well as an unpredictable course and
outcome in some cases. Several authors have reported that subconjunctival botulinum toxin
injection provides an immediate, effective treatment by reducing excessive levator function
in patients who suffer from disfiguring eyelid appearance and do not want to wait for
surgery for upper eyelid retraction. Botox treatment is usually temporary. However, unwanted
ptosis, although temporary, was observed in five out of 24 patients (20. 8%) in the study by
Costa, which may be even more disappointing and cosmetically unacceptable to some
patients. Recently, hyaluronic acid gel fillers, which were injected into the subconjunctival
levator-Muller plane, demonstrated efficacy in managing Graves' eyelid retraction in three
patients. However, complications such as a lumps, fluid buildup, and skin pigment darkening
may occur using this technique. Steroid treatment represents a well-established TAO
management strategy due to its anti-inflammatory and immunosuppressive actions. However,
multiple systemic side effects such as diabetes, infection, hypertension, osteoporosis, and
stomach ulcers are major drawbacks of systemic steroid treatment. Due to limitations of
systemic steroid treatment, several studies reported TAO improvement with periorbital
injections of methylprednisolone and triamcinolone, primarily focusing on reducing proptosis
and diplopia. So far, however, only a single small case series study has suggested that an
injection of 20 mg triamcinolone into the subconjunctival region of the lid, between the
conjunctiva and Muller's muscle, improves upper eyelid retraction within 1 month in three of
the four patients. The investigators are not aware of any study designed to demonstrate the
treatment efficacy of locally administered triamcinolone to improve eyelid retraction and
swelling in a prospective manner. Therefore, we aimed to evaluate both the short-term and
long-term effects of subconjunctival triamcinolone injections in treating eyelid retraction
and inflammatory swelling caused by TAO.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: change of Eyelid retraction grade
Secondary outcome: change of Eyelid swelling
Eligibility
Minimum age: 19 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- TAO symptom duration less than 6 months
- Eyelid retraction or swelling
- Participants who is able to sign a consent agreement and proceed study
Exclusion Criteria:
- Previous steroid or radiation treatment for TAO
- Compressive optic neuropathy
- Suspicious of glaucoma or high risk of intraocular pressure elevation
- Patients with eyeball pain and/ or 4 or more of Mourtis' clinical activity score(CAS)
- Patients who are not in euthyroid status at the start of study period and or the
whole duration of study period
- Pregnant or breast feeding women
Locations and Contacts
Severance hospital, Seoul 120-752, Korea, Republic of
Additional Information
Starting date: May 2012
Last updated: January 26, 2015
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