Angle-Closure GlaucomaNCT05563623
The Beijing Angle Closure Progression Study
An observational study of Angle-Closure Glaucoma, run by Peking University People's Hospital at 1 site in China.
Trial summary
The Beijing angle closure progression study (BAPS) aims to explore the 5-year incidence of PACS progressing to PAC or PACG and to determine the possible risk factors of disease progression, which may provide the evidence for choosing the accurate strategies in the management of PACS. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Angle-Closure Glaucoma
- How many people
- 825 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2022to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary angle-closure suspect who agree to take part in this trial were given a comprehensive baseline examination and who decline will be asked for a reason. Verbal and written informed consent was obtained from every patient. A comprehensive baseline examination will be done for every enrolled subjects. Patients are monitored for 5 years. All examinations that may be related to subjective judgment and manipulation, i.e. Goldmann applanation (GAT), ultrasound biomicroscopy (UBM), gonioscopy, are performed by experienced examiner.
Who may be able to join
- "Static" gonioscopy identifying 6 or more clock hours of angle circumference in which the posterior (usually pigmented) trabecular meshwork cannot be seen in both eyes with no peripheral anterior synechiae, and normal intraocular pressure (IOP), optic nerve and visual field.
- Able to provide informed consent
Who cannot join
- Any evidence of primary angle closure (a narrow angle as defined above, but with PAS and/or IOP > 21 mmHg) or primary angle closure glaucoma (visual field defect or glaucomatous optic neuropathy).
- Previous intraocular surgery or laser treatment, such as cataract surgery, laser trabeculoplasty, trabeculectomy, laser peripheral iridectomy, and laser iridoplasty
- Sign of prior acute attack, such as glaucomatous fleck, keratic precipitates, or iris atrophy.
- Anterior segment structural abnormalities shown by examination, such as iris or ciliary body tumor.
- Severe health problems precluding follow-up such as end-stage heart disease, kidney disease, or lung disease, or terminal cancer.
- Severe eye diseases, such as cataract, macular disease, and retinal detachment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beeijing, 100044
Huijuan Wu, 8613811293109, dr_wuhuijuan@126.com
About this study
Official title: The Beijing Angle Closure Progression Study (BAPS)
The Beijing angle closure progression study (BAPS) aims to explore the 5-year incidence of PACS progressing to PAC or PACG and to determine the possible risk factors of disease progression, which may provide the evidence for choosing the accurate strategies in the management of PACS.
Read the detailed description
Although the global prevalence of primary angle-closure glaucoma (PACG) is less than half that of primary open-angle glaucoma, the risk of serious bilateral visual impairment caused by PACG is three times more than that of primary open-angle glaucoma. PACG is the leading cause of irreversible blindness all over the world, characterized by closure of the anterior chamber angle. Primary angle closure suspect (PACS), the earliest stage of primary angle-closure diseases (PACD), is defined as no less than three quadrants of appositional contact between the peripheral iris and posterior trabecular meshwork on gonioscopy. The progression from PACS to primary angle closure (PAC) was defined as elevated intraocular pressure (IOP) and the presence of peripheral anterior synechiae (PAS). PACG was characterized as PAC together with evidence of glaucomatous optic neuropathy (GON) or glaucomatous visual field defects. It is estimated that by 2040, the number of PACG cases worldwide will reach 32 million, of which Asian cases account for a large proportion. Therefore, a better understanding the natural history of PACD may play an important role in preventing devastating visual impairment.
Previous studies have reported the prevalence of PAC and PACG was 1%-11.3%, but longitudinal reports on its incidence and progression of earlier stages of angle closure that precede PAC/PACG are scarce, especially for Asian population. A Danish study demonstrated that the rate of progression from the condition of shallow anterior chamber to PACG was 16% at ten-year follow-up. Studies in Asia showed that the rate of PACS progress to PAC or PACG was range from 5.3% to 25.5%. And the risk factors of progression included bilateral PACS, smaller angle width, shorter angle open distance, larger iris curvature, and older age. Of note, these studies evaluated the anterior chamber of subjects with examinations including IOLMaster, A scan, and anterior segment-optical coherence tomography (AC-OCT). However, the ultrasound biomicroscopy (UBM), which is most valuable examination in the evaluation of patients with angle closure, was not used. Thus, details such as the volume of the ciliary body, the degree of ciliary anterior rotation, and parameters related to the vitreous zonule (VZ) might have been neglected. In the past, laser peripheral iridotomy (LPI) was considered to be a precaution against progression of PACD, but a few studies postulated that the benefit of prophylactic LPI was limited for PACS. If PACS with high progression risks can be accurately identified, LPI could be applied to high-risk PACS patients rather than all. Therefore, the research on precise risk analysis for PACS progression is imperative.
The Beijing angle closure progression study (BAPS) aims to explore the 5-year incidence of PACS progressing to PAC or PACG and to determine the possible risk factors of disease progression, which may provide the evidence for choosing the accurate strategies in the management of PACS.
- Conditions
- Angle-Closure Glaucoma
- 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.
| Study group | Role | What they receive |
|---|---|---|
| progression group | Not described | |
| non-progression group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the progression rate 1
the rate of acute angle closureanterior synechiae
Measured: 6 months
the progression rate 2
the proportion of eyes developing peripheral
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start4 Aug 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Huijuan, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563623
- Sponsor's protocol ID
- PekingUPHOphthalmology001
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- 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 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Beijing Angle Closure Progression Study (BAPS)
- ClinicalTrials.gov ID
- NCT05563623
- Acronym / sponsor ID
- PekingUPHOphthalmology001
- Conditions
- Angle-Closure Glaucoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 825 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Oct 2022 (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 Beijing angle closure progression study (BAPS) aims to explore the 5-year incidence of PACS progressing to PAC or PACG and to determine the possible risk factors of disease progression, which may provide the evidence for choosing the accurate strategies in the management of PACS.
Detailed description
Although the global prevalence of primary angle-closure glaucoma (PACG) is less than half that of primary open-angle glaucoma, the risk of serious bilateral visual impairment caused by PACG is three times more than that of primary open-angle glaucoma. PACG is the leading cause of irreversible blindness all over the world, characterized by closure of the anterior chamber angle. Primary angle closure suspect (PACS), the earliest stage of primary angle-closure diseases (PACD), is defined as no less than three quadrants of appositional contact between the peripheral iris and posterior trabecular meshwork on gonioscopy. The progression from PACS to primary angle closure (PAC) was defined as elevated intraocular pressure (IOP) and the presence of peripheral anterior synechiae (PAS). PACG was characterized as PAC together with evidence of glaucomatous optic neuropathy (GON) or glaucomatous visual field defects. It is estimated that by 2040, the number of PACG cases worldwide will reach 32 million, of which Asian cases account for a large proportion. Therefore, a better understanding the natural history of PACD may play an important role in preventing devastating visual impairment.
Previous studies have reported the prevalence of PAC and PACG was 1%-11.3%, but longitudinal reports on its incidence and progression of earlier stages of angle closure that precede PAC/PACG are scarce, especially for Asian population. A Danish study demonstrated that the rate of progression from the condition of shallow anterior chamber to PACG was 16% at ten-year follow-up. Studies in Asia showed that the rate of PACS progress to PAC or PACG was range from 5.3% to 25.5%. And the risk factors of progression included bilateral PACS, smaller angle width, shorter angle open distance, larger iris curvature, and older age. Of note, these studies evaluated the anterior chamber of subjects with examinations including IOLMaster, A scan, and anterior segment-optical coherence tomography (AC-OCT). However, the ultrasound biomicroscopy (UBM), which is most valuable examination in the evaluation of patients with angle closure, was not used. Thus, details such as the volume of the ciliary body, the degree of ciliary anterior rotation, and parameters related to the vitreous zonule (VZ) might have been neglected. In the past, laser peripheral iridotomy (LPI) was considered to be a precaution against progression of PACD, but a few studies postulated that the benefit of prophylactic LPI was limited for PACS. If PACS with high progression risks can be accurately identified, LPI could be applied to high-risk PACS patients rather than all. Therefore, the research on precise risk analysis for PACS progression is imperative.
The Beijing angle closure progression study (BAPS) aims to explore the 5-year incidence of PACS progressing to PAC or PACG and to determine the possible risk factors of disease progression, which may provide the evidence for choosing the accurate strategies in the management of PACS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| progression group | – | – |
| non-progression group | – | – |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary angle-closure suspect who agree to take part in this trial were given a comprehensive baseline examination and who decline will be asked for a reason. Verbal and written informed consent was obtained from every patient. A comprehensive baseline examination will be done for every enrolled subjects. Patients are monitored for 5 years. All examinations that may be related to subjective judgment and manipulation, i.e. Goldmann applanation (GAT), ultrasound biomicroscopy (UBM), gonioscopy, are performed by experienced examiner.
Key inclusion criteria (2 listed)
- "Static" gonioscopy identifying 6 or more clock hours of angle circumference in which the posterior (usually pigmented) trabecular meshwork cannot be seen in both eyes with no peripheral anterior synechiae, and normal intraocular pressure (IOP), optic nerve and visual field.
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Any evidence of primary angle closure (a narrow angle as defined above, but with PAS and/or IOP > 21 mmHg) or primary angle closure glaucoma (visual field defect or glaucomatous optic neuropathy).
- Previous intraocular surgery or laser treatment, such as cataract surgery, laser trabeculoplasty, trabeculectomy, laser peripheral iridectomy, and laser iridoplasty
- Sign of prior acute attack, such as glaucomatous fleck, keratic precipitates, or iris atrophy.
- Anterior segment structural abnormalities shown by examination, such as iris or ciliary body tumor.
- Severe health problems precluding follow-up such as end-stage heart disease, kidney disease, or lung disease, or terminal cancer.
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
the progression rate 1
Time frame: 6 months
the rate of acute angle closureanterior synechiae
the progression rate 2
Time frame: 6 months
the proportion of eyes developing peripheral
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angle-Closure Glaucoma, run by Peking University People's Hospital at 1 site in China.
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 6 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: looking for participants now, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huijuan Wu, M.D. Ph.D. (8613811293109, dr_wuhuijuan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the progression rate 1 (time frame: 6 months). The study lists 2 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 3 Oct 2022.