Primary Angle-Closure GlaucomaNCT06333470
Liwan Eye Study: the Fourth Follow-up
An observational study of Primary Angle-Closure Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Primary Angle-Closure Glaucoma
- What is being tested?
- Primary angle closure diseases
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2024to 30 Sep 2024
- 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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Participants who have previously participated in the Liwan Eye Study
- Individuals who sign an informed consent form voluntarily
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Primary angle-closure glaucoma (PACG) is potentially a devastating disease, responsible for half of glaucoma-related blindness worldwide, especially in East Asia. 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 PACG. Thus, identifying PACS eyes at risk of angle closure is crucial for its management. However, the natural history of progression from PACS to PACG and its prediction models are still limited in long-term longitudinal studies. Meanwhile, visual impairment poses a significant global public health burden along with the accelerating trend of aging, it is imperative to further evaluate the visual impairment among the elderly population.
The Liwan Eye Study was a population-based study initiated in 2003. The decision to select Liwan District for the survey was taken because of its stable, older population and a socioeconomic profile representative of Guangzhou as a whole. At baseline, 1405 eligible subjects aged 50 years and older completed a comprehensive eye examination and a questionnaire interview regarding education, income, hypertension and diabetes mellitus. To improve the monitoring of PACS and prevent vision loss associated with PACG, the purposes of this observational cohort study are to investigate the 20-year incidence of PACG in Chinese population aged over 50 years, develop prediction models that include eye characteristics, demographic features, ocular imaging characteristics, and genetic factors for the long-term risk of progression from PACS to PACG. Moreover, we aim to investigate the 20-year change in visual impairment and associated factors.
- Conditions
- Primary Angle-Closure Glaucoma
- Being tested
- Primary angle closure diseases
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary angle closure diseasesOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Prediction model performance was assessed by discrimination and calibration.Discrimination was evaluated using the ROC curve and area under the curve (AUC) or C-statistics. Calibration was visualized through calibration plots and evaluated using the Hosmer-Lemeshow goodness-of-fit test (HL test).
Measured: 5-year, 10-year, 20-year
The 20-year incidence of visual impairment in Chinese population aged over 50 years
Visual acuity (VA) will be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR illiterate E VA chart. Visual impairment is defined as VA <20/60 \& ≥20/400, and blindness is defined as VA<20/400 in the better-seeing eye.
Measured: 20-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start30 Mar 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Angle-Closure GlaucomaStudies 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
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Wang, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333470
- Sponsor's protocol ID
- 2024KYPJ025
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liwan Eye Study: the Fourth Follow-up
- ClinicalTrials.gov ID
- NCT06333470
- Acronym / sponsor ID
- 2024KYPJ025
- Conditions
- Primary Angle-Closure Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 27 Mar 2024 (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.
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.
Detailed description
Primary angle-closure glaucoma (PACG) is potentially a devastating disease, responsible for half of glaucoma-related blindness worldwide, especially in East Asia. 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 PACG. Thus, identifying PACS eyes at risk of angle closure is crucial for its management. However, the natural history of progression from PACS to PACG and its prediction models are still limited in long-term longitudinal studies. Meanwhile, visual impairment poses a significant global public health burden along with the accelerating trend of aging, it is imperative to further evaluate the visual impairment among the elderly population.
The Liwan Eye Study was a population-based study initiated in 2003. The decision to select Liwan District for the survey was taken because of its stable, older population and a socioeconomic profile representative of Guangzhou as a whole. At baseline, 1405 eligible subjects aged 50 years and older completed a comprehensive eye examination and a questionnaire interview regarding education, income, hypertension and diabetes mellitus. To improve the monitoring of PACS and prevent vision loss associated with PACG, the purposes of this observational cohort study are to investigate the 20-year incidence of PACG in Chinese population aged over 50 years, develop prediction models that include eye characteristics, demographic features, ocular imaging characteristics, and genetic factors for the long-term risk of progression from PACS to PACG. Moreover, we aim to investigate the 20-year change in visual impairment and associated factors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- Participants who have previously participated in the Liwan Eye Study
- Individuals who sign an informed consent form voluntarily
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary angle closure diseasesPrimary 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). | Other | – |
Primary outcome
The 20-year incidence of primary angle-closure glaucoma (PACG) in Chinese population aged over 50 years
Time frame: 20-year
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.
2 secondary outcomes
The development of prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to primary angle-closure glaucoma (PACG)
Time frame: 5-year, 10-year, 20-year
The 20-year incidence of visual impairment in Chinese population aged over 50 years
Time frame: 20-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: Yes. 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.
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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.
Wei Wang, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Angle-Closure Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Wang, PhD ((0)20 87334687, wangwei@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 20-year incidence of primary angle-closure glaucoma (PACG) in Chinese population aged over 50 years (time frame: 20-year). 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 28 Mar 2024.