Analysis of the Pachychoroid Phenotype in an Asian Population

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.

Study Overview

• Status: Completed
• Conditions: Pachychoroid Disease

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 Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • National University Hospital
  • Singapore, Singapore
    • Singapore National Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will recruit 120 participants from the Singapore National Eye Centre (SNEC) and National University Hospital (NUH). SNEC will recruit 70 participants and NUH will recruit 50 participants for this study. There is no subject restriction based on race of the subject.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Singapore National Eye Centre
• Collaborators: National University Hospital, Singapore
• Investigators: Principal Investigator: Xinyi Su, MBBS, National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2020
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pachychoroid neovasculopathy; pachychoroid choroidal vasculopathy
• Other Study ID Numbers: R1661/58/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No