Analysis of the Pachychoroid Phenotype in an Asian Population

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04498000

Enrollment

112

Registered

2020-08-04

Start date

2020-07-22

Completion date

2023-11-30

Last updated

2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pachychoroid Disease

Keywords

pachychoroid neovasculopathy, pachychoroid choroidal vasculopathy

Brief summary

The understanding of pachychoroid phenotype is incomplete. It is important to understand the risk of conversion from an uncomplicated pachychoroid phenotype to the pachychoroid disease phenotype, to guide appropriate management of these patients.

Detailed description

The progression of uncomplicated pachychoroid phenotype to pachychoroid disease is not well established and the pathophysiology of these phenotypes remains unknown: specifically if the occurence of pachyvessels is the primary event, or develops secondary to the inner choroidal attenuation. A longitudinal study of the pachychoroid phenotype will provide much needed information regarding the natural history of the pachychoroid phenotype. Secondly, a detailed chronicle of the choroidal alterations in the pachychoroid disease spectrum may yield insights into the pathogenesis, and facilitate the development of disease modulation strategies.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Presence of uncomplicated and/or non-neovascular pachychoroid phenotype in at least one eye. 2. Subfoveal choroidal thickness \>300 microns on enhanced depth imaging optical coherence tomography for at least one eye 3. Male or female patients above 45 years of age 4. Willingness to undergo pupil dilation, and protocol- required procedures for both eyes 5. 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, including Spectral domain- optical coherence tomography during the study period 2. Pregnant or nursing women

Design outcomes

Primary

Measure	Time frame	Description
Incidence of progression of pachychoroid phenotypes in 2 subtypes	2 years observation	Two subtypes of pachychoroid phenotypes: 1. from an uncomplicated pachychoroid phenotype, to a pachychoroid disease entity 2. from non neo-vascular pachychoroid disease, to neovascular pachychoroid disease
Risk factors for progression in 2 subtypes of pachychoroid phenotypes	2 years	1. from an uncomplicated pachychoroid phenotype, to a pachychoroidal disease entity 2. from neo-vascular pachychoroid disease, to neovascular pachychoroid disease
Assess the chronology of choroidal changes in patients	2 years	Determine the occurence of pachyvessles is the primary event, or consequent to inner choroidal attenuation

Countries

Singapore

Outcome results