The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC

赞助:

合作者:

信息的提供 (责任方):

Jin Chen-jin，Sun Yat-sen University

追踪信息

首次提交日期 ^ICMJE

September 26, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

October 31, 2016

预计主要完成日期

October 10, 2018 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Changes of retinal capillaries after hd-PDT[ Time Frame: 1 month, 3 month ]

The primary outcome measure is the OCTA-based changes in the retinal capillaries after hd-PDT

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

The proportion of eyes with complete absorption of subretinal fluid(SRF)[ Time Frame: 1 month, 3 month ]
The outcome 2 measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images)
Change of Best Corrected Visual Acuity(BCVA)[ Time Frame: 1 month, 3 month ]
The outcome 3 measure is the EDTRS charts-based improvement of Best Corrected Visual Acuity
Changes of choroidal thickness after hd-PDT[ Time Frame: 1 month, 3 month ]
The outcome 4 measure is the OCT-based thinning of choroidal thickness after hd-PDT

描述性信息

简略标题 ^ICMJE

The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC

正式标题 ^ICMJE

The Changes of Retinal and Choroidal Capillaries After Half-dose Photodynamic Therapy Measured by Angio- OCT in Eyes With Central Serous Chorioretinopathy

简要概况

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).

详细说明

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.

研究类型 ^ICMJE

Observational

研究阶段

研究设计 ^ICMJE

分配:
干预模型:
干预模型描述:
盲法: Observational
盲法描述:
主要目的:

适用条件 ^ICMJE

干预项目 ^ICMJE

Procedure: Half-dose photodynamic therapy
Half-dose photodynamic therapy was achieved by administering 3mg/m² of Verteporfin (Visudyne; Novartis, Switzerland) intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the greatest linear dimension was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². 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 (one month and three months) visit after hd-PDT.

研究工具

: CSC patients
Half-dose photodynamic therapy was performed when a serous retinal detachment involving the macular fovea was present; The treatment field size was set as 3000 microns. This was achieved by administering 3mg/m² of Verteporfin intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the GLD was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². OCTA (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up (one month and three months) visit after hd-PDT.

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

June 30, 2019

预计主要完成日期

October 10, 2018 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. CSC diagnosed by FFA and ICGA, where the active leakage was just located in macular fovea with SRF confirmed by OCT 2. Patient age ≥18 years 3. BCVA ≥35 letters on ETDRS charts 4. Persistent CSC for a period of time or patients were anxiety about the symptom and asking for treatment 5. Lack of either spontaneous improvement or improvement induced by empirical treatment such as pharmaceutical drug 6. The provision of written informed consent - Exclusion Criteria: 1. The presence of any other chorioretinal diseases that may affect the studies, such as age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV) 2. Patients who had received any previous treatment, including PDT, intraocular drug injection or focal thermal laser photocoagulation for CSC 3. Patients with PED in macular fovea which the average diameter (transverse diameter and vertical diameter) was more than 300 microns 4. Patients with high myopia, defined as a refractive error (spherical equivalent) < -6.00 diopters, or an axial length >26.5 mm 5. Patients with media opacities, or signal strength index of the images < 60 6. Patients under corticosteroid therapy -

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：65 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

China

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: Yes

IPD 共享声明

计划分享 IPD:

Undecided

责任方

Jin Chen-jin，Sun Yat-sen University

研究赞助商 ^ICMJE

Jin Chen-jin

合作者 ^ICMJE

研究员 ^ICMJE

Study Director: Chenjin Jin Zhongshan Ophthalmic Center, Sun Yat-sen University

PRS 账户

Sun Yat-sen University

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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