Analysis of the Pachychoroid Phenotype in an Asian Population

April 16, 2024 updated by: Gemmy Cheung Chui Ming, Singapore National Eye Centre
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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 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
2 years observation
Risk factors for progression in 2 subtypes of pachychoroid phenotypes
Time Frame: 2 years
  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
Time Frame: 2 years
Determine the occurence of pachyvessles is the primary event, or consequent to inner choroidal attenuation
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore National Eye Centre

Collaborators

National University Hospital, Singapore

Investigators

  • Principal Investigator: Xinyi Su, MBBS, National University Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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