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Central Serous Chorioretinopathy Registry and Pachychoroid Observation and Natural History Study

NCT05278169 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2023-08-30

No results posted yet for this study

Summary

Objectives:

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. Collect genetic samples of affected individuals and their families to establish whether there is a genetic basis for the disease.
3. To create a Registry of patients affected by CSCR who may agree to be contacted for inclusion in future clinical trials.
4. 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.

Conditions

  • Central Serous Chorioretinopathy

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Danny Siu-Chun Ng, FHKAM(Ophth) · Chinese University of Hong Kong

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05278169 on ClinicalTrials.gov