Thyroid Eye Disease, TED
Conditions
Keywords
Upper Eyelid Retraction, Oculoplastic Surgery, Triamcinolone Acetonide
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.
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.
Interventions
DRUGTriamcinolone 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).
Sponsors
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label single-arm study in which both investigators and participants are aware of the intervention administered.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Margin Reflex Distance 1 (MRD1) | Baseline and 1 Month After Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Palpebral Fissure Height | Baseline and 1 Month After Treatment | 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. |
| Change in Intraocular Pressure | Baseline, 1 Week, and 1 Month After Treatment | Evaluation of the change in intraocular pressure measured in mmHg before treatment and after triamcinolone acetonide injection as a safety outcome. |
Countries
Mexico
Outcome results
None listed