Efficacy of Transseptal and Transconjunctival Triamcinolone Acetonide Injection for the Treatment of Upper Eyelid Retraction in Patients With Thyroid Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Margin Reflex Distance 1 (MRD1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label single-arm study in which both investigators and participants are aware of the intervention administered.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Previous or current systemic corticosteroid treatment during the study period.
- •Active thyroid eye disease with Clinical Activity Score (CAS) ≥
- •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.
研究组 & 干预措施
Triamcinolone Injection
Participants with upper eyelid retraction secondary to thyroid eye disease receive local triamcinolone acetonide injection administered through combined transconjunctival and transseptal approaches.
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Change in Margin Reflex Distance 1 (MRD1)
时间窗: 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.
次要结局
- Change in Palpebral Fissure Height(Baseline and 1 Month After Treatment)
- Change in Intraocular Pressure(Baseline, 1 Week, and 1 Month After Treatment)