NCT07471997

Triamcinolone Acetonide Injection for Upper Eyelid Retraction in Thyroid Eye Disease

Efficacy of Transseptal and Transconjunctival Triamcinolone Acetonide Injection for the Treatment of Upper Eyelid Retraction in Patients With Thyroid Eye Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Thyroid eye disease frequently causes upper eyelid retraction, which can lead to ocular surface complications and cosmetic concerns. Several medical and surgical treatments have been proposed; however, minimally invasive therapies remain of interest. This study evaluates the efficacy of local triamcinolone acetonide injection administered through transconjunctival and transseptal routes for the treatment of upper eyelid retraction in patients with inactive thyroid eye disease. Patients with thyroid eye disease and upper eyelid retraction were treated with a combined subconjunctival and transcutaneous injection of triamcinolone acetonide. Clinical measurements including margin reflex distance 1 (MRD1), palpebral fissure height, visual acuity, intraocular pressure, and Clinical Activity Score (CAS) were evaluated before treatment and one month after intervention.

Detailed description

Thyroid eye disease (TED) is an autoimmune inflammatory disorder characterized by orbital tissue expansion and eyelid abnormalities. Upper eyelid retraction is the most common clinical sign and may cause ocular exposure, discomfort, and significant cosmetic concerns. The pathophysiology of eyelid retraction in TED involves inflammation and fibrosis of eyelid retractors, including the levator palpebrae superioris and Müller muscle. Although surgical correction is effective, it is generally reserved for the inactive stage of the disease. Therefore, medical therapies aimed at reducing inflammation and modulating eyelid retractor function have been explored. Triamcinolone acetonide is a synthetic corticosteroid with potent anti-inflammatory effects and prolonged local action due to its depot formulation. Local administration may reduce inflammation of eyelid tissues while minimizing systemic adverse effects. This prospective interventional study evaluates the efficacy of triamcinolone acetonide administered through combined transconjunctival and transseptal injections in patients with upper eyelid retraction secondary to inactive thyroid eye disease. Participants were recruited from the Thyroid Clinic at the Conde de Valenciana Institute of Ophthalmology. Each patient received a subconjunctival injection of triamcinolone acetonide above the superior tarsal border and a transcutaneous injection into the upper eyelid. Clinical parameters including margin reflex distance 1 (MRD1), palpebral fissure height, visual acuity, intraocular pressure, eyelid crease height, and Clinical Activity Score were recorded at baseline and one month after treatment. The primary objective of the study is to evaluate changes in MRD1 after treatment. Secondary outcomes include changes in palpebral fissure height, intraocular pressure, visual acuity, and clinical activity score. Safety outcomes include the evaluation of adverse effects associated with periocular corticosteroid injection.

Conditions

• Thyroid Eye Disease, TED

Interventions

Type	Name	Description
DRUG	Triamcinolone Acetonide	Triamcinolone acetonide administered as a subconjunctival injection (0.3 mL; 12 mg) above the superior tarsal border combined with a transseptal upper eyelid injection (0.2 mL; 8 mg).

Timeline

• Start date: 2024-06-20
• Primary completion: 2025-02-20
• Completion: 2025-02-20
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: Mexico