NCT07523139

Brief Summary

This study aims to investigate the role of the vitreous zonule (VZ) in the pathogenesis of primary angle-closure glaucoma (PACG) and to explore the feasibility of three-dimensional ultrasound biomicroscopy (3D-UBM) for imaging the circumferential VZ. This prospective, observational study will enroll patients with primary angle-closure disease (PACD), including primary angle-closure suspect (PACS), primary angle-closure (PAC), and PACG, as well as healthy controls. All participants will undergo comprehensive ophthalmic examinations, including gonioscopy, biometric measurements using IOLMaster, and UBM imaging. The study consists of three main components: (1) analysis of VZ morphology, location, number of visible quadrants, and anterior segment parameters across different age groups and axial length groups in healthy individuals, with comparisons to age-matched PACD patients; (2) development and validation of a 3D-UBM imaging system using a rotational scanning approach to reconstruct the spatial structure of the VZ; and (3) characterization of VZ features, including density and morphology, in normal eyes versus PACD eyes using 3D-UBM. The primary outcomes include the presence, quadrant count, and morphological characteristics (vitreous zonule-pars plana angle and maximum distance) of the VZ, as well as anterior segment parameters such as lens vault, anterior chamber depth, trabecular-iris angle, and angle opening distance. By elucidating age-related and axial length-related changes in the VZ and establishing 3D-UBM as a novel imaging modality for the posterior zonular apparatus, this study seeks to provide new evidence for the mechanistic role of the VZ in angle-closure glaucoma and to identify potential imaging biomarkers for early diagnosis and risk stratification.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jan 2025

Typical duration 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

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Study Timeline

Key milestones and dates

Study Progress53%
Jan 2025Jun 2027

Study Start

First participant enrolled

January 1, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

April 5, 2026

Last Update Submit

April 5, 2026

Conditions

Keywords

Ultrasound BiomicroscopyVitreous ZonuleThree-dimensional Imaging

Outcome Measures

Primary Outcomes (1)

  • Vitreous Zonule Visibility on Ultrasound Biomicroscopy

    Presence and quadrant count of the VZ assessed by ultrasound biomicroscopy (UBM). VZ is defined as fibrous bands extending from the pars plana to the posterior lens equator or ciliary processes. Presence is defined as VZ visible in at least one quadrant; quadrant count ranges from 0 to 4.

    Baseline

Study Arms (4)

Group 1 Healthy Controls

Group 2 Primary Angle-Closure Suspects (PACS)

Group 3 Primary Angle Closure

Group 4 Primary Angle Closure Glaucoma

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be recruited from the Department of Ophthalmology at Peking University People's Hospital, a tertiary referral center in Beijing, China. Participants will include patients diagnosed with primary angle-closure disease (PACS, PAC, and PACG) and healthy controls with open angles. Patients will be identified from outpatient clinics and through routine ophthalmic examinations. Healthy controls will be recruited from volunteers undergoing routine eye examinations, as well as from hospital staff and community members. All participants will be recruited prospectively and consecutively to minimize selection bias.

You may qualify if:

  • \. Age between 30 and 80 years, inclusive. 2. Diagnosis of primary angle-closure disease (PACS, PAC, or PACG) according to standardized gonioscopic criteria; or healthy controls with open angles. 3. Lens opacity graded \< 2 for cortical and nuclear opacities according to the Lens Opacities Classification System III (LOCS III). 4. Ability and willingness to provide written informed consent.

You may not qualify if:

  • \. Any intraocular disease affecting the anterior or posterior segment, including but not limited to corneal disease, iris abnormalities, lens disorders other than age-related cataract, vitreous disorders, uveoretinal diseases, or optic neuropathies. 2. Prior intraocular surgery or laser treatment, including cataract surgery, trabeculectomy, laser trabeculoplasty, laser peripheral iridotomy, laser iridoplasty, or vitreoretinal surgery. 3. Systemic diseases that may affect ocular examination or confound measurements, such as end-stage cardiac disease, renal disease, pulmonary disease, or advanced malignancy. 4. Inability to undergo ultrasound biomicroscopy (UBM) examination due to inability to maintain supine position or other contraindications. 5. Pregnancy or lactation. 6. Any condition that, in the opinion of the investigator, would compromise the participant's ability to comply with study procedures or affect the validity of the study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Central Study Contacts

Kun Lv, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 13, 2026

Study Start

January 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations