Treatment of Upper Eyelid Retraction Related to Thyroid-associated Ophthalmopathy Using Subconjunctival Triamcinolone Injections

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01599273
First received: May 10, 2012
Last updated: May 13, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Thyroid-associated Ophthalmopathy
Drug: subconjunctival triamcinolone injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • change of Eyelid retraction grade [ Time Frame: At 3, 6, and 9 weeks after the initial injection, and finally at 24 weeks post-injection. ] [ Designated as safety issue: No ]
    Injection (Group 1) and observation-only controls (Group II). At 3, 6, and 9 weeks after the initial injection, and finally at 24 weeks post-injection for group I. In Group II, eyelids were evaluated at 9 and 24 weeks after the initial visit.


Secondary Outcome Measures:
  • change of Eyelid swelling [ Time Frame: At 3, 6, and 9 weeks after the initial injection, and finally at 24 weeks post-injection ] [ Designated as safety issue: No ]
    Patients are randomized into two groups: Injection (Group 1) and observation-only controls (Group II). At 3, 6, and 9 weeks after the initial injection, and finally at 24 weeks post-injection. In Group II, eyelids were evaluated at 9 and 24 weeks after the initial visit.


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triam inj Drug: subconjunctival triamcinolone injection
Patients are randomized into two groups: Injection (Group 1) and observation-only controls (Group II). In Group I, patients were treated with 1-3 injections of 20 mg triamcinolone acetate using a 30-gauge needle into the subconjunctival region of the lid between the conjunctiva and Muller's muscle. Injections were stopped after 1-2 injections if both swelling and retraction resolved completely, or if one eye scored 0 and the contralateral eye scored 1, and there existed no patient concern after physician inquiry regarding function and cosmetic appearance.
No Intervention: observation group

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599273

Contacts
Contact: Jin Sook Yoon, MD 82-2-2228-3570 yoonjs@yuhs.ac

Locations
Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jin Sook Yoon, MD    82-2-2228-3570    yoonjs@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01599273     History of Changes
Other Study ID Numbers: 4-2012-0164
Study First Received: May 10, 2012
Last Updated: May 13, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
thyroid-associated ophthalmopathy
triamcinolone
retraction
swelling

Additional relevant MeSH terms:
Eye Diseases
Graves Ophthalmopathy
Eye Diseases, Hereditary
Thyroid Diseases
Endocrine System Diseases
Graves Disease
Exophthalmos
Orbital Diseases
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014