Central Serous Chorioretinopathy Registry and Pachychoroid Observation and Natural History Study

NCT05278169 | Unknown DMC

• 1 other identifier: CSCR POOH
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 3

Brief Summary

Objectives:

1. 1.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.
2. 2.Collect genetic samples of affected individuals and their families to establish whether there is a genetic basis for the disease.
3. 3.To create a Registry of patients affected by CSCR who may agree to be contacted for inclusion in future clinical trials.
4. 4.To determine the incidence and risk factors for progression of pachychoroid phenotypes identified from the unaffected fellow eyes of CSCR patients.

Conditions

Central Serous Chorioretinopathy

Keywords

Central Serous Chorioretinopathy; Pachychoroid; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (3)

• Longitudinal change of retinal pigment epithelium defects on Fundus Autofluorescence (FAF) from baseline and between visits.

  Fundus Autofluorescence - performed using Spectralis (Heidelberg Engineering, Heidelberg, Germany) to acquire 35 degree and 55 degree image centred on the fovea.

  At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.

• Longitudinal change of retinal pigment epithelium defects on Spectral Domain Optical Coherence Tomography (SD-OCT) from baseline and between visits.

  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.

  At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.

• Longitudinal change of retinal pigment epithelium defects on infrared imaging from baseline and between visits.

  Ultra-widefield color fundus photography and autofluorescence (Optos PLC, Dunfermline, UK) - performed to capture 240 degree image centred on the fovea.

  At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.

Secondary Outcomes (43)

• 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.

• 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.

• Incidence of intraretinal cysts.

  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.

• Incidence of type 1 choroidal neovascularization.

  At baseline (Month 0), Month 6, Month 12, Month 18 and Month 24.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study aims to enrol a total of 350 patients with CSCR, of which: * 170 subjects from a previous cross-sectional observation study titled 'The Association of Sleep Disturbances and Maculopathy' (IRB / REC No.: 2018.158) at the CUHK Eye Centre. * An addition of 180 subjects will be recruited during the proposed study duration. Of the 180 new recruits, 100 will be recruited from Hong Kong Eye Hospital and CUHK Eye Centre.The remaining 80 subjects will be recruited from Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (3)

CUHK Eye Centre

Hong Kong, Hong Kong

Location

Hong Kong Eye Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (12)

• Tsai DC, Chen SJ, Huang CC, Chou P, Chung CM, Huang PH, Lin SJ, Chen JW, Chen TJ, Leu HB, Chan WL. Epidemiology of idiopathic central serous chorioretinopathy in Taiwan, 2001-2006: a population-based study. PLoS One. 2013 Jun 24;8(6):e66858. doi: 10.1371/journal.pone.0066858. Print 2013.

  PMID: 23826160 BACKGROUND

• Kitzmann AS, Pulido JS, Diehl NN, Hodge DO, Burke JP. The incidence of central serous chorioretinopathy in Olmsted County, Minnesota, 1980-2002. Ophthalmology. 2008 Jan;115(1):169-73. doi: 10.1016/j.ophtha.2007.02.032.

  PMID: 18166410 BACKGROUND

• Daruich A, Matet A, Dirani A, Bousquet E, Zhao M, Farman N, Jaisser F, Behar-Cohen F. Central serous chorioretinopathy: Recent findings and new physiopathology hypothesis. Prog Retin Eye Res. 2015 Sep;48:82-118. doi: 10.1016/j.preteyeres.2015.05.003. Epub 2015 May 27.

  PMID: 26026923 BACKGROUND

• Chan WM, Lai TY, Lai RY, Liu DT, Lam DS. Half-dose verteporfin photodynamic therapy for acute central serous chorioretinopathy: one-year results of a randomized controlled trial. Ophthalmology. 2008 Oct;115(10):1756-65. doi: 10.1016/j.ophtha.2008.04.014. Epub 2008 Jun 5.

  PMID: 18538401 BACKGROUND

• Dansingani KK, Balaratnasingam C, Klufas MA, Sarraf D, Freund KB. Optical Coherence Tomography Angiography of Shallow Irregular Pigment Epithelial Detachments In Pachychoroid Spectrum Disease. Am J Ophthalmol. 2015 Dec;160(6):1243-1254.e2. doi: 10.1016/j.ajo.2015.08.028. Epub 2015 Aug 28.

  PMID: 26319161 BACKGROUND

• Ng DS, Bakthavatsalam M, Lai FH, Cheung CY, Cheung GC, Tang FY, Tsang CW, Lai TY, Wong TY, Brelen ME. Classification of Exudative Age-Related Macular Degeneration With Pachyvessels on En Face Swept-Source Optical Coherence Tomography. Invest Ophthalmol Vis Sci. 2017 Feb 1;58(2):1054-1062. doi: 10.1167/iovs.16-20519.

  PMID: 28195603 BACKGROUND

• Bakthavatsalam M, Ng DS, Lai FH, Tang FY, Brelen ME, Tsang CW, Lai TY, Cheung CY. Choroidal structures in polypoidal choroidal vasculopathy, neovascular age-related maculopathy, and healthy eyes determined by binarization of swept source optical coherence tomographic images. Graefes Arch Clin Exp Ophthalmol. 2017 May;255(5):935-943. doi: 10.1007/s00417-017-3591-3. Epub 2017 Feb 1.

  PMID: 28150038 BACKGROUND

• Lai FH, Ng DS, Bakthavatsalam M, Chan VC, Young AL, Luk FO, Tsang CW, Brelen ME. A Multicenter Study on the Long-term Outcomes of Half-dose Photodynamic Therapy in Chronic Central Serous Chorioretinopathy. Am J Ophthalmol. 2016 Oct;170:91-99. doi: 10.1016/j.ajo.2016.07.026. Epub 2016 Aug 9.

  PMID: 27519561 BACKGROUND

• Lai TY, Chan WM, Li H, Lai RY, Liu DT, Lam DS. Safety enhanced photodynamic therapy with half dose verteporfin for chronic central serous chorioretinopathy: a short term pilot study. Br J Ophthalmol. 2006 Jul;90(7):869-74. doi: 10.1136/bjo.2006.090282. Epub 2006 Apr 5.

  PMID: 16597666 BACKGROUND

• Chan WM, Lai TY, Lai RY, Tang EW, Liu DT, Lam DS. Safety enhanced photodynamic therapy for chronic central serous chorioretinopathy: one-year results of a prospective study. Retina. 2008 Jan;28(1):85-93. doi: 10.1097/IAE.0b013e318156777f.

  PMID: 18185143 BACKGROUND

• van Dijk EHC, Fauser S, Breukink MB, Blanco-Garavito R, Groenewoud JMM, Keunen JEE, Peters PJH, Dijkman G, Souied EH, MacLaren RE, Querques G, Downes SM, Hoyng CB, Boon CJF. Half-Dose Photodynamic Therapy versus High-Density Subthreshold Micropulse Laser Treatment in Patients with Chronic Central Serous Chorioretinopathy: The PLACE Trial. Ophthalmology. 2018 Oct;125(10):1547-1555. doi: 10.1016/j.ophtha.2018.04.021. Epub 2018 Jun 14.

  PMID: 29776672 BACKGROUND

• Li WX, Muyese A, Xie ZT, Liu WH, Zhang B. Validity and reliability of the Chinese version of Morningness/Eveningness Questionnaire- 5 items(MEQ-5) in students of technical schools. Chinese Mental Health Journal. 2016; 6: 406-412.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A 10 mL blood sample will be drawn by venipuncture during the first (baseline) visit for genetics analysis.

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Danny Siu-Chun Ng, FHKAM(Ophth)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: March 14, 2022
• Study Start: March 11, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

HK (3)