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

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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Eye Disease, TED
• Intervention / Treatment: Drug: Triamcinolone Acetonide

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A. P.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triamcinolone Injection; Participants with upper eyelid retraction secondary to thyroid eye disease receive local triamcinolone acetonide injection administered through combined transconjunctival and transseptal approaches.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Margin Reflex Distance 1 (MRD1)	Evaluation of the change in upper eyelid position measured as Margin Reflex Distance 1 (MRD1), defined as the distance from the corneal light reflex to the upper eyelid margin. Measurements are obtained before treatment and one month after triamcinolone acetonide injection.	Baseline and 1 Month After Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Palpebral Fissure Height	Evaluation of the change in palpebral fissure height, defined as the vertical distance between the upper and lower eyelid margins, measured at baseline and one month after triamcinolone acetonide injection.	Baseline and 1 Month After Treatment
Change in Intraocular Pressure	Evaluation of the change in intraocular pressure measured in mmHg before treatment and after triamcinolone acetonide injection as a safety outcome.	Baseline, 1 Week, and 1 Month After Treatment

Collaborators and Investigators

• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: March 7, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Triamcinolone Acetonide; Upper Eyelid Retraction; Oculoplastic Surgery
• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Graves Ophthalmopathy; Polycyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Triamcinolone Acetonide
• Other Study ID Numbers: OT-TRIAMCINOLONE-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No