Analysis of the Pachychoroid Phenotype in an Asian Population

Pachychoroid Disease Clinical Trial

Official title:

Analysis of the Pachychoroid Phenotype in an Asian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498000
• Other study ID #: R1661/58/2019
• Status: Completed
• Start date: July 22, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pachychoroid Disease

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore
Singapore	Singapore National Eye Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore National Eye Centre	National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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