Triamcinolone Acetonide Injection for Upper Eyelid Retraction in Thyroid Eye Disease

NCT07471997 | Completed DMC

• 1 other identifier: OT-TRIAMCINOLONE-2024
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Eye Disease, TED

Keywords

Upper Eyelid Retraction; Oculoplastic Surgery; Triamcinolone Acetonide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Palpebral Fissure Height

  Baseline and 1 Month After Treatment

• Change in Intraocular Pressure

  Baseline, 1 Week, and 1 Month After Treatment

Study Arms (1)

Triamcinolone Injection

EXPERIMENTAL

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

Interventions

Triamcinolone Acetonide DRUG

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).

Triamcinolone Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A. P.

Mexico City, Mexico

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label single-arm study in which both investigators and participants are aware of the intervention administered.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with upper eyelid retraction secondary to thyroid eye disease receive a single treatment consisting of combined transconjunctival and transseptal triamcinolone acetonide injection. Clinical measurements are evaluated before treatment and one month after the intervention to assess changes in eyelid position and ocular parameters.

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 16, 2026
• Study Start: June 20, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ME (1)