NCT01630863Unknown不适用
The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Changes of best corrected visual acuity
研究概览
简要总结
To find the safe effective lowest light dose for photodynamic therapy (PDT). in the treatment of central serous chorioretinopathy.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
- •Presence of SRF and/or serous pigment epithelial detachment on optical coherence tomography (OCT)
- •Presence of abnormal dilated choroidal vasculature in ICGA
- •Patients with symptomatic CSC of at least 3 months duration
排除标准
- •Patients who received any previous treatment, including PDT or focal thermal laser photocoagulation for CSC, or who had evidence of CNV, PCV, or other maculopathy on clinical examination, FA, or ICGA
- •Patients receiving exogenous corticosteroid treatment
- •Patients with systemic diseases such as Cushing's disease or renal diseases
- •Pregnant patients
研究组 & 干预措施
50% group
Experimental
power of PDT is applied to the patients at 50% of the full energy based on TAP study.
干预措施: Photodynamic therapy (Procedure)
40% group
Experimental
Decreasing power of PDT is applied to the patients at 40% of the full energy based on TAP study.
干预措施: Photodynamic therapy (Procedure)
30% group
Experimental
Decreasing power of PDT is applied to the patients at 30% of the full energy based on TAP study.
干预措施: Photodynamic therapy (Procedure)
结局指标
主要结局
Changes of best corrected visual acuity
时间窗: 6 month
Changes of best corrected visual acuity at baseline and 1, 3, 6 month after PDT
次要结局
- Change of central retinal thickness, success rate, recurrence rate, and complications(6 months)
研究者
Min Sagong
Assistant Professor
Yeungnam University College of Medicine
研究点 (1)
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