Analysis of the Pachychoroid Phenotype in an Asian Population

Completed

• Conditions: Pachychoroid Disease

• Registration Number: NCT04498000
• Lead Sponsor: Singapore National Eye Centre

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.

Study Timeline

• Study Start: 2020-07-22
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-08-04
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

National University Hospital; 🇸🇬 Singapore, Singapore

Singapore National Eye Centre; 🇸🇬 Singapore, Singapore