ISRCTN46696624已完成未知
Prostaglandin F2-alpha eye drops (BIMAtoprost) in thyroid eye disease: a randomised controlled double blind crossover trial
Cardiff University (UK)0 个研究点目标入组 31 人开始时间: 2014年3月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 31
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30880626 (added 13/06/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Stable TED with no reported change in proptosis for at least 6 months
- •2. Clinical activity score <3
- •3. Proptosis (subjective unilateral proptosis confirmed by asymmetry in exophthalmometry of >2 mm OR greater than 20 mm on exophthalmometry measurement in one eye)
- •4. Euthyroid (FT3 and FT4 in the reference range)
- •5. If female, must be using a reliable form of contraception during the trial, e.g. oral contraceptive and condom, intrauterine device (IUD) and condom, diaphragm with spermicide and condom
排除标准
- •1. Age <18 years
- •2. Dysthyroid optic neuropathy unless previously treated
- •3. Pregnancy or lactation
- •4. Previous corneal herpes simplex infection
- •5. On therapy for glaucoma or intraocular hypertension
- •6. Less than 6 months from prior steroid use
- •7. Aphakia, pseudophakia with torn posterior lens capsule or anterior chamber lenses
- •8. Patient with risk factors for cystoid macular oedema, iritis or uveitis
- •9. Severe asthma (risk of severe allergic reaction to medication).
- •10. Previous allergy to Bimatoprost or preservative
研究者
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