Progression Patterns of Choroidal Venous Alterations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pachychoroid Disease. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong, Malaysia, Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
International Multi-centre, Prospective, Longitudinal Cohort to Evaluate the Progression Pattern of Choroidal Venous Alterations
Overview
This study is about understanding how a condition called pachychoroid changes over time. Pachychoroid refers to an anatomic choroidal characteristic with abnormally thick choroid or abnormally dilated Haller's vessels. Pachychoroid can range from mild forms which does not cause any problems to more serious ones that might cause vision loss.This study will recruit participants with pachychoroid, to learn more about how this condition develops, how it affects people in the long run, and what factors might make it worse.
Detailed description
This study aims to document the longitudinal progression pattern and the incidence rate of progression of choroidal venous alteration (defined as either an increase in number of quadrants with pachyvessels or formation of new anastomoses which violates the physiological watershed It will provide valuable natural history data to study the pattern of evolution of choroidal vessels over time and validate the proposed multi-hit theory over a period of three years.
Primary outcome measures
- Progression of choroidal venous alterations [Time frame: 3 years]
Secondary outcome measures (2)
- Incidence of progression of pachychoroid disease manifestation [Time frame: 3 years]
- Risk factors associated with progression of choroidal venous alteration [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Adults aged 45 years or older.
- Presence of pachyvessels on ultra-widefield (UWF) imaging in at least one quadrant.
- Willing to undergo pupil dilation, and protocol-required procedures for both eyes
- Willing to provide written informed consent
Exclusion criteria
- Presence of disorders of the ocular media which interfere with visual acuity and other ocular assessments during the study period
- Eyes with other ocular pathology such as trauma, inflammation, previous intraocular surgery (except for cataract surgery)
- Systemic diseases that might affect ocular blood flow such as uncontrolled hypertension, autoimmune disease, and haematological disorders
- Pregnant or nursing women
- Persons who are unable to give informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Singapore · 2 centers
- National University Hospital, Singapore — Singapore
- Singapore National Eye Centre/ Singapore Eye Research Institute — Singapore
Hong Kong · 1 center
- Hong Kong University — Hong Kong
Malaysia · 1 center
- University of Malaya Medical Centre — Kuala Lumpur
Identifiers
NCT: NCT07236671 · 2024-4359