Clinical trial NCT04498000: Analysis of the Pachychoroid Phenotype in an Asian Population
Official title: Analysis of the Pachychoroid Phenotype in an Asian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pachychoroid Disease
Keywords: pachychoroid neovasculopathy
pachychoroid choroidal vasculopathy
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
Collaborators: name: National University Hospital, Singapore
First posted: 2020-08-04
Enrollment: 112
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of progression of pachychoroid phenotypes in 2 subtypes
timeFrame: 2 years observation
measure: Risk factors for progression in 2 subtypes of pachychoroid phenotypes
timeFrame: 2 years
measure: Assess the chronology of choroidal changes in patients
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
affiliation: National University Hospital, Singapore
name: Xinyi Su, MBBS
role: PRINCIPAL_INVESTIGATOR
References: