The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Tear film thickness as measured with OCT
研究概览
简要总结
Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye disease, is a common orbital disease in adults. Patients with TAO, especially in its active phase, often complain about symptoms of ocular surface discomfort, including excess tearing, gritty sensation, increased sensitivity to light and foreign-body sensation, which are similar to inflammatory ocular surface disorders such as dry-eye syndrome (DES). Incomplete blink, increased proptosis and greater palpebral fissure width in TAO accelerates tear evaporation, which increases the tear fluid's osmolarity, and results in ocular surface damage. The administration of intravenous glucocorticoids can be an effective treatment for TAO.
The rationale of the present study is to assess the effect of intravenously administered glucocorticoids on the signs of DES in patients with TAO with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film and well established methods for assessment of the severity of DES. Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.
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
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
- •Men and women aged over 18 years
- •Active thyroid associated ophthalmopathy with clinical activity score (CAS) of each eye more than 3 or recently experienced worsening of proptosis, lid retraction, or ocular motility disturbance.
- •Normal ophthalmic findings except symptoms associated with TAO
- •Scheduled for treatment with systemic glucocorticoids according to the kahaly-scheme
排除标准
- •Chronic inactive TAO
- •Previous treatment with oral or intravenous glucocorticoids 3 months preceding the study
- •Participation in a clinical trial in the 3 weeks before the screening visit
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
- •Wearing of contact lenses
- •Intake of dietary supplements in the 3 months preceding the study
- •Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants
- •Ocular infection
- •Ocular surgery in the 3 months preceding the study
- •Sjögren's syndrome
- •Stevens-Johnson syndrome
- •Pregnancy, planned pregnancy or lactating
研究组 & 干预措施
Patients
Patients with moderate to severe thyroid-associated ophthalmopathy
干预措施: Methylprednisolone (Drug)
Patients
Patients with moderate to severe thyroid-associated ophthalmopathy
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Tear film thickness as measured with OCT
时间窗: 13 weeks
Measurements of tear film thickness with OCT will be performed 7 or less days before start of treatment, 6 weeks after start of treatment and 12 weeks after start of treatment
次要结局
- Staining of the cornea with fluorescein(13 weeks)
- Schirmer I test(13 weeks)
- Subjective symptoms of dry eye syndrome(13 weeks)
- Break up time (BUT)(13 weeks)
- Visual acuity(13 weeks)
- Tear film osmolarity(13 weeks)
- Degree of exophthalmia(13 weeks)
- Palpebral fissure width(13 weeks)
- OSI (Objective Scattering Index)(13 weeks)
- Tear cytokines/chemokines(13 weeks)
- Impression cytology(13 weeks)
研究者
Gerhard Garhofer
Ass. Prof. PD. Dr.
Medical University of Vienna