NCT05507840尚未招募不适用
Photobiomodulation for Dry Age Related Macula Degeneration
Oslo University Hospital0 个研究点目标入组 121 人开始时间: 2022年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 121
- 主要终点
- Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up
研究概览
简要总结
The study will investigate the effect of photobiomodulation treatment on the risk of developing late age related macula degeneration (AMD) in the study eye in patients with wet AMD in the fellow eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with dry AMD in the study eye and wet AMD in the control eye
排除标准
- •Geographic atrophy of the central macular region at enrolment
- •Previous/ active wet AMD in the study eye
- •A history of epilepsy
- •Retinal diseases apart from AMD
- •Significant media opacities
- •Cataracts worse than grade 2 (LOCS III classification)
- •Change in AREDS 2 supplements (vitamins) 1 month before the study and during the study trial was allowed.
- •Ongoing systemic medications that are photosensitizing (e.g. tetracyclins)
- •Systemic medications during the last 6 months that can cause deposits in the macular region (hydroxychloroquine, amiodarone)
- •Unable to give informed consent
- •Unable to cooperate with the treatment and follow-up
结局指标
主要结局
Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up
时间窗: 3 years
次要结局
未报告次要终点
研究者
ANCA ROALD
Principal Investigator, MD dr. med.
Oslo University Hospital
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