The Changes of Retinal and Choroidal Capillaries After Half-dose Photodynamic Therapy Measured by Angio- OCT in Eyes With Central Serous Chorioretinopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes of retinal capillaries after hd-PDT
研究概览
简要总结
To determine changes in retinal and choroidal capillaries with optical coherence tomographic angiography (OCTA) after half-dose photodynamic therapy (hd-PDT) in eyes with central serous chorioretinopathy (CSC).
详细描述
PDT was hypothesized to have a primary effect on the choroidal capillaries, and a number of studies have reported choriocapillary damage and choroidal vascular remodeling after PDT. More recently, although OCTA related CSC research has been conducted, no quantitative report has thoroughly investigated the microstructural changes in the superficial, deep retinal and choroidal capillaries after hd-PDT. The purpose of the present study is to determine the changes in the retinal and choroidal capillaries quantitatively with OCTA after hd-PDT in eyes with CSC.
This is a prospective observational study of patients undergoing hd-PDT for CSC with active leakage in retinal pigment epithelium (RPE) and followed for 3 months. Fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA) were performed at baseline; best corrected visual acuity (BCVA), fundus photography, optical coherence tomography angiography (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up visit after hd-PDT.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CSC diagnosed by FFA and ICGA, where the active leakage was just located in macular fovea with SRF confirmed by OCT
- •Patient age ≥18 years
- •BCVA ≥35 letters on ETDRS charts
- •Persistent CSC for a period of time or patients were anxiety about the symptom and asking for treatment
- •Lack of either spontaneous improvement or improvement induced by empirical treatment such as pharmaceutical drug
- •The provision of written informed consent -
排除标准
- •The presence of any other chorioretinal diseases that may affect the studies, such as age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV)
- •Patients who had received any previous treatment, including PDT, intraocular drug injection or focal thermal laser photocoagulation for CSC
- •Patients with PED in macular fovea which the average diameter (transverse diameter and vertical diameter) was more than 300 microns
- •Patients with high myopia, defined as a refractive error (spherical equivalent) < -6.00 diopters, or an axial length >26.5 mm
- •Patients with media opacities, or signal strength index of the images < 60
- •Patients under corticosteroid therapy -
结局指标
主要结局
Changes of retinal capillaries after hd-PDT
时间窗: 1 month, 3 month
The primary outcome measure is the OCTA-based changes in the retinal capillaries after hd-PDT
次要结局
- The proportion of eyes with complete absorption of subretinal fluid(SRF)(1 month, 3 month)
- Change of Best Corrected Visual Acuity(BCVA)(1 month, 3 month)
- Changes of choroidal thickness after hd-PDT(1 month, 3 month)
研究者
Jin Chen-jin
Jin Chen-jin
Sun Yat-sen University