Analysis of the Pachychoroid Phenotype in an Asian Population

NCT04498000 | Completed DMC

• 1 other identifier: R1661/58/2019
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 2

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.

Conditions

Pachychoroid Disease

Keywords

pachychoroid neovasculopathy; pachychoroid choroidal vasculopathy

Outcome Measures

Primary Outcomes (3)

• Incidence of progression of pachychoroid phenotypes in 2 subtypes

  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

  2 years observation

• Risk factors for progression in 2 subtypes of pachychoroid phenotypes

  1. from an uncomplicated pachychoroid phenotype, to a pachychoroidal disease entity 2. 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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Presence of uncomplicated and/or non-neovascular pachychoroid phenotype in at least one eye.
• Subfoveal choroidal thickness \>300 microns on enhanced depth imaging optical coherence tomography for at least one eye
• Male or female patients above 45 years of age
• Willingness to undergo pupil dilation, and protocol- required procedures for both eyes
• Willing to provide written informed consent

You may not qualify if:

• 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
• Pregnant or nursing women

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• National University Hospital, Singapore: collaborator

Study Sites (2)

National University Hospital

Singapore, Singapore

Location

Singapore National Eye Centre

Singapore, Singapore

Location

Study Officials

• Xinyi Su, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 4, 2020
• Study Start: July 22, 2020
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)