NCT02960828Unknown不适用
Focal Subthreshold Laser Treatment for Macular Drusen
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in drusen size
研究概览
简要总结
This study aims to validate the efficacy and safety of subthreshold laser photocoagulation on high-risk macular drusen in early age-related macular degeneration which has a high risk of conversion to exudative AMD.
详细描述
SAVE Study (Stop Early Age-related Macular Degeneration form Vision Loss Eternally)
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
- None
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
- •Drusen in both eyes examined under fundoscopy
- •At least one of the eyes must have high-risk soft drusen
- •BCVA below ETDRS 83 letters
- •Patient with consent to participate
排除标准
- •Prior diagnosis with choroidal neovascularization
- •Exudative AMD in at least one eye
- •If the patient has only one visually effective eye (last eye)
- •Other macula or retinal diseases than age-related macular degeneration
研究组 & 干预措施
Intervention-"Device:_Laser"
Experimental
- Subthreshold focal photocoagulation
- Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection
干预措施: Subthreshold Laser Photocoagulation (Procedure)
Intervention-"Device:_Laser"
Experimental
- Subthreshold focal photocoagulation
- Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection
干预措施: intravitreal Anti-VEGF injection (Drug)
Intervention-"Device:_Laser"
Experimental
- Subthreshold focal photocoagulation
- Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection
干预措施: Subthreshold Laser (Device)
结局指标
主要结局
Change in drusen size
时间窗: 3 month interval
次要结局
- Change in drusen distribution(3 month interval)
- Best Corrected Visual Acuity (BCVA)(3 months interval)
- Change in autofluorescence(3 month interval)
- Choroidal Neovascularization(3 months interval)
- Contrast Sensitivity(3 months interval)
研究者
Kyu Hyung Park
Professor, Chief of department of Ophthalmology
Seoul National University Bundang Hospital
研究点 (1)
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