NCT06333470

Brief Summary

Primary angle-closure glaucoma (PACG) is one of the major causes of blindness affecting more than 20 million patients worldwide. The goals of this observational cohort study are to investigate the 20-year incidence of PACG in Chinese population aged 50 years and to develop prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to PACG.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

March 21, 2024

Last Update Submit

March 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The 20-year incidence of primary angle-closure glaucoma (PACG) in Chinese population aged over 50 years

    The presence of PACG is determined by visual acuity, intraocular pressure, anterior segment optical coherence tomography (AS-OCT). The incidence of PACG is defined as the number of new cases of PACG divided by the number of individuals without PACG at baseline.

    20-year

Secondary Outcomes (2)

  • The development of prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to primary angle-closure glaucoma (PACG)

    5-year, 10-year, 20-year

  • The 20-year incidence of visual impairment in Chinese population aged over 50 years

    20-year

Interventions

Primary angle-closure suspect (PACS), which is characterized by appositional angle closure, is the earliest stage of primary angle closure diseases and can finally progress to primary angle-closure glaucoma (PACG).

Eligibility Criteria

Age70 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

All participants who will be follow-up in this study are from the Liwan Eye Study. At baseline, study subjects were enrolled in Liwan District, Guangzhou. (Liwan District is 1 of 10 administrative districts in Guangzhou, with a population of 514,600.) The decision to select this district for the survey was taken because of its stable, older population and a socioeconomic profile representative of Guangzhou as a whole. Individuals aged 50 years or more who had been resident in the selected study districts for more than 6 months were considered eligible during the enumeration. A total of 1405 eligible subjects were identified from the register.

You may qualify if:

  • Participants who have previously participated in the Liwan Eye Study
  • Individuals who sign an informed consent form voluntarily

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Human blood sample

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Wei Wang, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 27, 2024

Study Start

March 30, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

March 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Available on request. The datasets generated from the current study will be available upon request from Dr Wei Wang (wangwei@gzzoc.com) after the study is completed.

Shared Documents
STUDY PROTOCOL
Access Criteria
For access to the data, please contact the principal investigator after the study is completed.