- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07523139
Vitreous Zonule in Primary Angle-Closure Glaucoma
A Cross-Sectional, Prospective Observational Study on the Role of the Vitreous Zonule in the Pathogenesis of Primary Angle-Closure Glaucoma
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kun Lv, M.D.
- Phone Number: 13681213130
- Email: lvkun0327@163.com
Study Locations
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Beijing, China, 100044
- Recruiting
- Peking University People's Hospital
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Contact:
- Kun Lv, M.D.
- Phone Number: 13681213130
- Email: lvkun0327@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
1. 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.
Exclusion Criteria:
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. 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1 Healthy Controls
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Group 2 Primary Angle-Closure Suspects (PACS)
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Group 3 Primary Angle Closure
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Group 4 Primary Angle Closure Glaucoma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Vitreous Zonule Visibility on Ultrasound Biomicroscopy
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PekingUPHOphthalmology003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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