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Completed

NCT Number: NCT04498000

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.

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Key information

Conditions

Pachychoroid Disease

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Hospital, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Incidence of progression of pachychoroid phenotypes in 2 subtypes

    Time frame: 2 years observation

    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. Risk factors for progression in 2 subtypes of pachychoroid phenotypes

    Time frame: 2 years

    • from an uncomplicated pachychoroid phenotype, to a pachychoroidal disease entity
    • from neo-vascular pachychoroid disease, to neovascular pachychoroid disease

  3. 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

Sponsors and collaborators

Lead sponsor

Singapore National Eye Centre

Other Gov

Collaborators

  • National University Hospital, Singapore

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2020
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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