跳至主要内容
临床试验/NCT03339856
NCT03339856已完成不适用

Selective Retina Therapy With Real-Time Feedback-Controlled Dosimetry for Treating Acute Idiopathic Central Serous Chorioretinopathy in Korean Patients

Kim's Eye Hospital0 个研究点目标入组 16 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
主要终点
Subretinal fluid

研究概览

简要总结

Selective retina therapy (SRT) selectively disrupts the retinal pigment epithelium (RPE) with minimal damage to the photoreceptors. Previous studies have shown SRT to be effective for resolving SRF, while causing only minimal collateral damage to the retina and vision.However, most patients included in prior studies had chronic CSC (≥3 months symptom duration) and SRT efficacy on acute CSC is not fully known.

The current study evaluated short-term treatment outcomes following SRT with real-time feedback-controlled dosimetry in Korean patients with acute idiopathic CSC.

详细描述

Central serous chorioretinopathy (CSC) is a disorder that is characterized by a localized serous detachment of the neurosensory retina in the posterior pole. Additionally, CSC is often self-limiting and spontaneous resolution of subretinal fluid (SRF) often occurs within several months. Although several treatment modalities (e.g., laser photocoagulation, photodynamic therapy, and anti-vascular endothelial growth factor [VEGF] therapy have been used in CSC patients, a consensus has not yet been reached on the optimal time for intervention.

Selective retina therapy (SRT) selectively disrupts the retinal pigment epithelium (RPE) with minimal damage to the photoreceptors. Previous studies have shown SRT to be effective for resolving SRF, while causing only minimal collateral damage to the retina and vision. However, most patients included in prior studies had chronic CSC (≥3 months symptom duration) and SRT efficacy on acute CSC is not fully known.

When treating CSC patients, it is generally recommended to follow-up several months without any intervention to identify spontaneous resolution of SRF. However, prompt treatment may be beneficial for some patients. For example, metamorphopsia or micropsia associated with CSC can greatly interfere with driving or with work when an occupation requires delicate procedures. Additionally, patients are often psychologically distressed by a CSC diagnosis and the accompanying decrease in vision-related quality of life. In these cases, prompt treatment to reduce SRF may relieve, at least in part, CSC symptoms and their related stress.

The current study evaluated short-term treatment outcomes following SRT with real-time feedback-controlled dosimetry in Korean patients with acute idiopathic CSC.

This study included patients who were diagnosed with treatment-naïve idiopathic CSC and were treated with SRT. The R:GEN device (Lutronic, Goyang-si, South Korea) was used to administer SRT. Inclusion criteria also included SRF involving the fovea (documented by optical coherence tomography [OCT] performed at initial presentation) and symptom duration shorter than 3 months. Patients were excluded from analyses if any of the following were true: (1) age > 55 years, (2) clinical or angiographic features suggestive of choroidal neovascularization, (3) OCT findings suggestive of type 1 neovascularization or polypoidal choroidal vasculopathy (e.g., double layer sign or fibrovascular pigment epithelial detachment), (4) history of macular laser photocoagulation, photodynamic therapy, or anti-VEGF therapy, or (5) history of exogenous corticosteroid treatment for a systemic disease (e.g., Cushing's syndrome or renal disease).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with treatment-naïve idiopathic central serous chorioretinopathy

排除标准

  • age > 55 years,
  • Clinical or angiographic features suggestive of choroidal neovascularization
  • Optical coherence tomography findings suggestive of type 1 neovascularization or polypoidal choroidal vasculopathy (e.g., double layer sign or fibrovascular pigment epithelial detachment).
  • History of macular laser photocoagulation, photodynamic therapy, or anti-vascular-endothelial growth factor therapy.
  • History of exogenous corticosteroid treatment for a systemic disease (e.g., Cushing's syndrome or renal disease).

研究组 & 干预措施

Treatment arm

Experimental

Patients received selective retina therapy

干预措施: Selective retina therapy (Device)

结局指标

主要结局

Subretinal fluid

时间窗: 3 months after treatment

Presence or absence of subretinal fluid which identified based on optical coherence tomography images.

次要结局

  • Visual acuity(At diagnosis, at 1 month, and 3 months after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jae Hui Kim

Principal Investigator

Kim's Eye Hospital

相似试验