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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04498000
Other study ID # R1661/58/2019
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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