NCT06346405招募中不适用
Central Serous Chorioretinopathy and Micropulse Laser Treatment: Evaluation of Morphological and Functional Recovery
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年5月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Vessel density changes
研究概览
简要总结
To evaluate choroidal and choriocapillaris changes in patients with central serous chorioretinopathy, undergone sub threshold micropulse laser treatment, following any improvement with conservative therapy with Acetazolamide and/or Eplerenone
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of central serous chorioretinopathy (CSC) with no response to conservative therapy, consisted in Acetazolamide and Eplerenone after six months.
- •Foveal serous retinal detachment for at least 6 months.
- •Minimum age of 18 years old at the screening time
- •Reading and comprehension skills of informed consent
排除标准
- •Previous retinal treatment for CSC, except for Acetazolamide and Eplerenone
- •No diffuse retinal epitheliopathy
- •Other concomitant ocular diseases, such as age related macular degeneration, diabetic retinopathy, choroidal neovascularization
- •Not controlled glaucoma with eyedrops, or advanced glaucoma
- •Myopia or hypermetropia greater than 6 diopters
- •Opacities of dioptric media
- •Low quality of optical coherence tomography (OCT) and OCT-Angiography scans
- •Low quality images of Fluorescein angiography and indocyanine green angiography
- •No written consensus signed.
结局指标
主要结局
Vessel density changes
时间窗: 12 and 24 months
Evaluation of changes in vessel density of choriocapillaris by optical coherence tomography (OCT) angiography before and after treatment
次要结局
- Choroidal thickness(12 and 24 months)
- Quality of life (QoL)(12 and 24 months)
- Metamorphopsia(12 and 24 months)
- Choroidal thickness and vessel density(12 and 24 months)
- Improvement in retinal function(12 and 24 months)
- Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern(12 and 24 months)
- Ellipsoid zone and BCVA(12 and 24 months)
- Metamorphopsia and BCVA(12 and 24 months)
- Ellipsoid Zone Integrity(12 and 24 months)
研究者
Savastano Maria Cristina
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究点 (1)
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