A Cross-Sectional, Prospective Observational Study on the Role of the Vitreous Zonule in the Pathogenesis of Primary Angle-Closure Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Vitreous Zonule Visibility on Ultrasound Biomicroscopy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Age between 30 and 80 years, inclusive.
- •Diagnosis of primary angle-closure disease (PACS, PAC, or PACG) according to standardized gonioscopic criteria; or healthy controls with open angles.
- •Lens opacity graded < 2 for cortical and nuclear opacities according to the Lens Opacities Classification System III (LOCS III).
- •Ability and willingness to provide written informed consent.
排除标准
- •1. 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.
- •Prior intraocular surgery or laser treatment, including cataract surgery, trabeculectomy, laser trabeculoplasty, laser peripheral iridotomy, laser iridoplasty, or vitreoretinal surgery.
- •Systemic diseases that may affect ocular examination or confound measurements, such as end-stage cardiac disease, renal disease, pulmonary disease, or advanced malignancy.
- •Inability to undergo ultrasound biomicroscopy (UBM) examination due to inability to maintain supine position or other contraindications.
- •Pregnancy or lactation.
- •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.
研究组 & 干预措施
Group 1 Healthy Controls
Group 2 Primary Angle-Closure Suspects (PACS）
Group 3 Primary Angle Closure
Group 4 Primary Angle Closure Glaucoma
结局指标
主要结局
Vitreous Zonule Visibility on Ultrasound Biomicroscopy
时间窗: Baseline
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.
次要结局
未报告次要终点
研究者
Wu Huijuan
Professor
Peking University People's Hospital