Pachychoroid DiseaseNCT04498000
Analysis of the Pachychoroid Phenotype in an Asian Population
An observational study of Pachychoroid Disease, run by Singapore National Eye Centre at 2 sites in Singapore.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Pachychoroid Disease
- How many people
- 112 participants
- Where
- 2 sitesSingapore
- Study dates
- 22 Jul 2020to 30 Nov 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National University Hospital
Singapore
Singapore National Eye Centre
Singapore
About this study
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.
Read the 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.
- Conditions
- Pachychoroid Disease
- Keywords
- pachychoroid neovasculopathy, pachychoroid choroidal vasculopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years observation
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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start22 Jul 2020
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pachychoroid DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Principal investigator, Gemmy Cheung Chui Ming, Singapore National Eye Centre
- Investigators
- Xinyi Su, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498000
- Sponsor's protocol ID
- R1661/58/2019
- Status last verified
- Apr 2024
- First submitted
- 30 Jul 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Pachychoroid Phenotype in an Asian Population
- ClinicalTrials.gov ID
- NCT04498000
- Acronym / sponsor ID
- R1661/58/2019
- Conditions
- Pachychoroid Disease
- Keywords
- pachychoroid neovasculopathy, pachychoroid choroidal vasculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- National University Hospital, Singapore
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinyi Su, MBBS principal investigator
National University Hospital, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pachychoroid Disease, run by Singapore National Eye Centre at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of progression of pachychoroid phenotypes in 2 subtypes (time frame: 2 years observation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.