Treatment of Upper Eyelid Retraction Related to Thyroid-associated Ophthalmopathy Using Subconjunctival Triamcinolone Injections
Primary Purpose
Thyroid-associated Ophthalmopathy
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
subconjunctival triamcinolone injection
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid-associated Ophthalmopathy focused on measuring thyroid-associated ophthalmopathy, triamcinolone, retraction, swelling
Eligibility 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
Sites / Locations
- Severance hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Triam inj
observation group
Arm Description
Outcomes
Primary Outcome Measures
change of Eyelid retraction grade
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01599273
Brief Title
Treatment of Upper Eyelid Retraction Related to Thyroid-associated Ophthalmopathy Using Subconjunctival Triamcinolone Injections
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid-associated Ophthalmopathy
Keywords
thyroid-associated ophthalmopathy, triamcinolone, retraction, swelling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triam inj
Arm Type
Experimental
Arm Title
observation group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
subconjunctival triamcinolone injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of Eyelid retraction grade
Description
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.
Time Frame
At 3, 6, and 9 weeks after the initial injection, and finally at 24 weeks post-injection.
Secondary Outcome Measure Information:
Title
change of Eyelid swelling
Description
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.
Time Frame
At 3, 6, and 9 weeks after the initial injection, and finally at 24 weeks post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22968823
Citation
Lee SJ, Rim TH, Jang SY, Kim CY, Shin DY, Lee EJ, Lee SY, Yoon JS. Treatment of upper eyelid retraction related to thyroid-associated ophthalmopathy using subconjunctival triamcinolone injections. Graefes Arch Clin Exp Ophthalmol. 2013 Jan;251(1):261-70. doi: 10.1007/s00417-012-2153-y. Epub 2012 Sep 12.
Results Reference
derived
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Treatment of Upper Eyelid Retraction Related to Thyroid-associated Ophthalmopathy Using Subconjunctival Triamcinolone Injections
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