NCT05563623

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
825

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Aug 2022Dec 2030

Study Start

First participant enrolled

August 4, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

3.4 years

First QC Date

September 26, 2022

Last Update Submit

September 29, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • the progression rate 1

    the rate of acute angle closureanterior synechiae

    6 months

  • the progression rate 2

    the proportion of eyes developing peripheral

    6 months

Study Arms (2)

progression group

non-progression group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • "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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beeijing, 100044, China

RECRUITING

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Central Study Contacts

Huijuan Wu, M.D. Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Leader of Glaucoma Group of Ophthalmology Department, Peking University People's Hospital

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 3, 2022

Study Start

August 4, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

October 3, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations