Triamcinolone Acetonide Injection for Upper Eyelid Retraction in Thyroid Eye Disease (TREAT-OT)

Instituto de Oftalmología Fundación Conde de Valenciana

Status: Completed

Conditions: Thyroid Eye Disease, TED

Treatments: Drug: Triamcinolone Acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT07471997

OT-TRIAMCINOLONE-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants aged 18 years or older.
• Diagnosis of thyroid eye disease.
• Presence of upper eyelid retraction defined as margin reflex distance 1 (MRD1) ≥ 4.5 mm.
• Clinical Activity Score (CAS) lower than 3 points.
• Ability and willingness to provide written informed consent.

Exclusion criteria

• Previous or current systemic corticosteroid treatment during the study period.
• Active thyroid eye disease with Clinical Activity Score (CAS) ≥ 3.
• Other causes of eyelid retraction.
• Need for urgent surgical management.
• Known allergy to triamcinolone acetonide.
• Known steroid responders.
• Diagnosis of advanced primary or secondary glaucoma according to Hodapp-Parrish-Anderson criteria.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Triamcinolone Injection

Experimental group

Description:

Participants with upper eyelid retraction secondary to thyroid eye disease receive local triamcinolone acetonide injection administered through combined transconjunctival and transseptal approaches.

Treatment:

Drug: Triamcinolone Acetonide