Progression Patterns of Choroidal Venous Alterations

NCT07236671 — Recruiting, 250 participants, Singapore National Eye Centre

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International Multi-centre, Prospective, Longitudinal Cohort to Evaluate the Progression Pattern of Choroidal Venous Alterations

Registry	NCT07236671, acronym CVA
Status	Recruiting
Study type	Observational
Enrollment	250 (Estimated)
Sponsor	Singapore National Eye Centre (Other gov); collaborators: National University Hospital, Singapore, University of Malaya, Hong Kong University
Conditions	Pachychoroid Disease
Dates	start 2025-03-04, primary completion 2029-06-01 (estimated), completion 2029-08-01 (estimated), first posted 2025-11-19, last updated 2026-06-12
Locations	4 sites in Hong Kong, Malaysia, Singapore

-Summary

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.

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+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.

+Outcome measures

Primary outcomes

Progression of choroidal venous alterations [3 years]: Proportion of eyes demonstrating progression of choroidal venous alterations, defined as either an increase in number of quadrants with pachyvessels or formation of new choroidal anastomoses.

Secondary outcomes

Incidence of progression of pachychoroid disease manifestation [3 years]: New onset of Central Serous Chorioretinopathy (CSCR), focal Retinal Pigment Epithelium (RPE) changes, or other pachychorois related findings.
Risk factors associated with progression of choroidal venous alteration [3 years]: Assessment of demographic, cilinical, and imaging parameters associated with progression.

+Eligibility

Sex: All, ages: 45 Years to any

Inclusion Criteria:

1. Adults aged 45 years or older.
2. Presence of pachyvessels on ultra-widefield (UWF) imaging in at least one quadrant.
3. Willing to undergo pupil dilation, and protocol-required procedures for both eyes
4. Willing to provide written informed consent

Exclusion Criteria:

1. Presence of disorders of the ocular media which interfere with visual acuity and other ocular assessments during the study period
2. Eyes with other ocular pathology such as trauma, inflammation, previous intraocular surgery (except for cataract surgery)
3. Systemic diseases that might affect ocular blood flow such as uncontrolled hypertension, autoimmune disease, and haematological disorders
4. Pregnant or nursing women
5. Persons who are unable to give informed consent

+Locations (4)

Facility	City	Country	Status
Hong Kong University	Hong Kong	Hong Kong	Recruiting
University of Malaya Medical Centre	Kuala Lumpur	Malaysia	Recruiting
National University Hospital, Singapore	Singapore	Singapore	Recruiting
Singapore National Eye Centre/ Singapore Eye Research Institute	Singapore	Singapore	Recruiting