NCT01863238已完成不适用
An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 主要终点
- Cataracts (lens opacities)
研究概览
简要总结
This study is designed to evaluate the risk of cataracts (lens opacities) and describe the best corrected distance vision (with glasses/contacts for those who wear them) of pediatric patients with Cystic Fibrosis who are 11 years of age or younger at the time of ivacaftor treatment initiation and are receiving or planning to receive commercially-available ivacaftor in the US.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be 11 years of age or younger at the time of treatment initiation with ivacaftor (as part of clinical trial) or commercially-available ivacaftor.
- •Subject must reside in the US and be receiving or planning to receive commercially-available ivacaftor.
排除标准
- •Subject is enrolled in an ivacaftor clinical study in which ivacaftor exposure is mandated by the protocol.
- •Subject has received surgery for cataracts
研究组 & 干预措施
Ivacaftor Treated
干预措施: Ophthalmologic examinations (Other)
Ivacaftor Treated
干预措施: Ivacaftor Exposed (Drug)
结局指标
主要结局
Cataracts (lens opacities)
时间窗: Through Month 24
Best corrected distance vision
时间窗: Through Month 24
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract SurgeryPosterior Capsule OpacificationPostoperative ComplicationsNCT02491918Iladevi Cataract and IOL Research Center61
Unknown
1 期
Treatment for Presumed Ocular HistoplasmosisOcular HistoplasmosisNCT01790893John Kitchens, MD40
已完成
不适用
Study of ocular safety for 222 nm UVC room disinfection lampJPRN-UMIN000042867Shimane University5
已完成
不适用
Study to Gather Information on the Safety and Use of Aflibercept Injections Into the Eye for the Treatment of Eye Disorders in Mexican Routine Clinical PracticeRetinal DiseaseNCT04137120Bayer73
已完成
3 期
Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS PlusCataractNCT00333268Alcon Research369