Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 7
- 主要终点
- Drusen Volume Variation
研究概览
简要总结
The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are:
- Is Yellow and Red Light Emitting Diode photobiomodulation effective in decreasing drusen volume in patients affected by dry AMD?
- Does Yellow and Red Light Emitting Diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry AMD? Participants will be randomly assigned to a treatment or a sham group.
Treatment consists in two cycles with two phases each:
- 1st phase: 300 seconds of continuous Yellow light with eyes closed + 60 seconds of pulsed Yellow light with eyes opened;
- 2d phase: 300 seconds of continuous Red light with eyes closed + 60 seconds of pulsed Red light with eyes opened.
Cycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks).
Researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.
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, Investigator)
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
- •BCVA ETDRS > 40 L ETDRS at 4 meters
- •Diagnosis of DRY AMD AREDS grade 2-3
- •Ability to communicate well with the investigator and able to understand and comply with the requirements of the study
排除标准
- •Concomitant epilepsy
- •Neurological diseases
- •Psychiatric pathologies
- •Herpes virus infections
- •Dense cataract
- •Pregnancy
- •Other significant ocular and/or retinal diseases
结局指标
主要结局
Drusen Volume Variation
时间窗: 1 month, 2 months and 4 months after each cycle
Based on SD-OCT Heidelberg
Best Corrected Visual Acuity variation
时间窗: 1 month, 2 months and 4 months after each cycle
ETDRS letters
Contrast sensitivity variation
时间窗: 1 month, 2 months and 4 months after each cycle
Based on Pelli Robson chart
次要结局
未报告次要终点
研究者
Giuseppe Giannaccare
Professor
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro