CClinicalTrials.gg
CompletedNCT01599273Updated Jan 28, 2015

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

A Phase 4 interventional study of subconjunctival triamcinolone injection in Thyroid-associated Ophthalmopathy, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-01-28.

Sponsored by Yonsei University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Thyroid-associated Ophthalmopathy

Keywords

  • thyroid-associated ophthalmopathy
  • triamcinolone
  • retraction
  • swelling
03

In context

Eye Diseases

740 studies on the registry are indexed under Eye Diseases; 118 are open to participants now.

This study's enrollment of 50 is below the median of 69 across 548 interventional studies indexed under Eye Diseases.

Browse Eye Diseases studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Triam inj

    Drug: subconjunctival triamcinolone injection

  • No intervention
    observation group

Interventions

  • Drugsubconjunctival 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At 3, 6, and 9 weeks after the initial injection, and finally at 24 weeks post-injection.

Secondary outcomes

  1. 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.

    Time frame: At 3, 6, and 9 weeks after the initial injection, and finally at 24 weeks post-injection

07

Study locations

1 site
  • Severance hospital
    Seoul, 120-752, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 22968823 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01599273
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
May 16, 2012
Start date
May 2012
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Jan 28, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion