Central Serous Chorioretinopathy Registry and Pachychoroid Observation and Natural History Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
- 试验地点
- 3
- 主要终点
- Longitudinal change of retinal pigment epithelium defects on Fundus Autofluorescence (FAF) from baseline and between visits.
研究概览
简要总结
Objectives:
- To conduct a Natural History Observation Study to characterize the clinical features and progression of Central Serous Chorioretinopathy (CSCR) from the earliest to the vision-threatening stages.
- Collect genetic samples of affected individuals and their families to establish whether there is a genetic basis for the disease.
- To create a Registry of patients affected by CSCR who may agree to be contacted for inclusion in future clinical trials.
- To determine the incidence and risk factors for progression of pachychoroid phenotypes identified from the unaffected fellow eyes of CSCR patients.
Design and subjects:
Observation, non-interventional study with prospective follow-up for 2 years. The study aims to enroll 350 patients with CSCR (100 from Hong Kong Eye Hospital, 80 from Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital, and 170 from Chinese University of Hong Kong (CUHK) Eye Centre at Hong Kong Eye Hospital).
Study instruments:
Functional tests include visual acuity and microperimetry. Retinal imaging with non-invasive ultra-widefield colour fundus camera, fundus autofluorescence (FAF) and optical coherence tomography (OCT). Questionnaires for risk factor profiling and quality of life assessment. Blood specimen will be collected for genetic testing if found to have a clinical diagnosis of CSCR as determined at CUHK Eye Centre at Hong Kong Eye Hospital.
Main outcome measures:
The primary outcome will be longitudinal alteration of retinal pigment epithelium defects on FAF, spectral domain (SD) OCT and infrared imaging. The secondary outcomes are: 1) progressive attenuation of outer nuclear layer (ONL), external limiting membrane (ELM) and ellipsoid zone (EZ) on SD OCT, 2) longitudinal changes of subfoveal choroidal thickness on swept source (SS) OCT, 3) incidence and onset of intraretinal cysts, 4) incidence and onset of type 1 choroidal neovascularization, 5) rate of choriocapillaris non- perfusion on SS OCT angiography (OCTA), 6) rate of loss of retinal sensitivity using microperimetry tests, 7) rate of visual acuity loss, 8) epidemiology of risk factors associated with CSCR, 9) identification of genes and the genetic variants that are associated with susceptibility to CSCR and 10) documentation of the clinical course of serous retinal detachment recurrence(s), persistence and resolution.
详细描述
Significance and Applications of Study Results:
I) The proposed study will determine comprehensive clinical characterization of a large cohort of 350 CSCR patients with novel, non-invasive imaging techniques to examine the ultrastructure of the choroid and retina to detect subtle changes that are not visible through routine eye check and conventional fundoscopy examination.
II) To understand the pathophysiology of CSCR through studying ultrastructural changes of chorioretina and genotypes.
III) Longitudinal data from this study will determine CSCR progression risks and treatment outcomes. Our large CSCR database will be a unique, large cohort study with robust clinical and molecular characterizations. This knowledge could help to develop realistic and effective diagnostic tests and individualized treatments for CSCR, and aid in the design of future clinical trials.
Data analysis:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence or evidence of prior serous retinal detachment documented on OCT involving the posterior pole unrelated to another disease process.
- •At least 1 area of retinal pigment epithelium (RPE) alteration on FAF, SD-OCT, or infrared imaging.
- •Subfoveal choroidal thickness (SFCT) of 300μm or more on SD enhanced depth imaging (EDI) OCT or SS-OCT for at least one eye.
- •Patient 18 years or older.
- •Willing to undergo pupil dilation, and protocol-required procedures for both eyes.
排除标准
- •Other maculopathy on clinical examination such as age-related macular degeneration (AMD).
- •Media opacity such as cataract that could interfere with adequate acquisition of fundal images.
- •Pregnant or nursing women.
结局指标
主要结局
Longitudinal change of retinal pigment epithelium defects on Fundus Autofluorescence (FAF) from baseline and between visits.
时间窗: At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.
Fundus Autofluorescence - performed using Spectralis (Heidelberg Engineering, Heidelberg, Germany) to acquire 35 degree and 55 degree image centred on the fovea.
Longitudinal change of retinal pigment epithelium defects on Spectral Domain Optical Coherence Tomography (SD-OCT) from baseline and between visits.
时间窗: At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.
Macular Spectral Domain Optical Coherence Tomography (SD-OCT) - performed using Spectralis (Heidelberg Engineering, Heidelberg, Germany) to acquire a 6x6 mm cube comprising of 97 retinal scans centred on the fovea.
Longitudinal change of retinal pigment epithelium defects on infrared imaging from baseline and between visits.
时间窗: At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.
Ultra-widefield color fundus photography and autofluorescence (Optos PLC, Dunfermline, UK) - performed to capture 240 degree image centred on the fovea.
次要结局
- Epidemiological association of use of oral corticosteroids with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of use of antihistamines with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of use of nasal sprays that contain pseudoephedrine and oxymetazoline with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of body-mass index (BMI) with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of findings in ultra-widefield color fundus photography and autofluorescence with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of findings in OCT angiography with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of morningness - eveningness choronotype with CSCR.(At baseline (Month 0).)
- Epidemiological association of sleep quality with CSCR.(At baseline (Month 0).)
- Epidemiological association of severity of insomnia with CSCR.(At baseline (Month 0).)
- Epidemiological association of depression with CSCR.(At baseline (Month 0), Month 12 and Month 24.)
- Progressive attenuation of outer nuclear layer (ONL), external limiting membrane (ELM) and ellipsoid zone (EZ) on SD-OCT.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Incidence of type 1 choroidal neovascularization.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Changes of retinal sensitivity using microperimetry tests.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of use of intravenous corticosteroids with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Incidence of intraretinal cysts.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Changes of choriocapillaris non-perfusion on SS OCT angiography (OCTA).(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of medical history with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of use of dermal corticosteroids with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of findings in microperimetry with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Number of Participants with serous retinal detachment(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Visual acuity changes.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of use of intra-articular corticosteroids with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of use of antacids with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of findings in Macular Spectral Domain Optical Coherence Tomography (SD-OCT) with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Changes of subfoveal choroidal thickness on swept source optical coherence tomography (SS-OCT).(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Onset of intraretinal cysts.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Onset of type 1 choroidal neovascularization.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of use of periocular corticosteroids with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of use of epidural corticosteroids with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of use of phosphodiesterase-5 inhibitors with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of blood pressure (BP) with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of findings in Macular Swept Source Optical Coherence Tomography (SS-OCT) with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of excessive daytime sleepiness with CSCR.(At baseline (Month 0).)
- Epidemiological association of quality of life with CSCR.(At baseline (Month 0), Month 12 and Month 24.)
- Epidemiological association of use of intravitreal corticosteroids with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of use of intranasal corticosteroids with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of previous findings in fluorescein and indocyanine green angiography images with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of best corrected visual acuity with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of autorefraction with CSCR.(At baseline (Month 0).)
- Epidemiological association of axial length measurement with CSCR.(At baseline (Month 0).)
- Epidemiological association of findings in Fundus Autofluorescence with CSCR.(At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.)
- Epidemiological association of anxiety with CSCR.(At baseline (Month 0), Month 12 and Month 24.)
- Association of single nucleotide polymorphism (SNP) with susceptibility to CSCR(At baseline (Month 0).)
研究者
Dr Danny Siu-Chun NG
Associate Professor
Chinese University of Hong Kong