Treatment of Upper Eyelid Retraction Related to Thyroid-associated Ophthalmopathy Using Subconjunctival Triamcinolone Injections
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ClinicalTrials.gov Identifier: NCT01599273 |
Recruitment Status :
Completed
First Posted : May 16, 2012
Last Update Posted : January 28, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thyroid-associated Ophthalmopathy | Drug: subconjunctival triamcinolone injection | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
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 |
- change of Eyelid retraction grade [ Time Frame: At 3, 6, and 9 weeks after the initial injection, and finally at 24 weeks post-injection. ]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.
- change of Eyelid swelling [ Time Frame: At 3, 6, and 9 weeks after the initial injection, and finally at 24 weeks post-injection ]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.

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Ages Eligible for Study: | 19 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599273
Korea, Republic of | |
Severance hospital | |
Seoul, Korea, Republic of, 120-752 |
Responsible Party: | Yonsei University |
ClinicalTrials.gov Identifier: | NCT01599273 |
Other Study ID Numbers: |
4-2012-0164 |
First Posted: | May 16, 2012 Key Record Dates |
Last Update Posted: | January 28, 2015 |
Last Verified: | January 2015 |
thyroid-associated ophthalmopathy triamcinolone retraction swelling |
Eye Diseases Graves Ophthalmopathy Thyroid Diseases Endocrine System Diseases Eye Diseases, Hereditary Graves Disease Exophthalmos Orbital Diseases Genetic Diseases, Inborn Goiter |
Hyperthyroidism Autoimmune Diseases Immune System Diseases Triamcinolone Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |