- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07549711
Morphological-Gene-Clinical Phenotype Correlation Study of the Long Anterior Zonule
April 17, 2026 updated by: Fuzhou Eye Hospital
A Morphological, Genetic, and Clinical Phenotype Association Study of the Long Anterior Zonule (LAZ) Based on Multimodal Imaging and Genetic Testing
Long anterior zonules (LAZ) is an anatomical anomaly of the anterior segment in which zonular fibers extend abnormally forward onto the anterior lens capsule.
It is potentially associated with glaucoma, late-onset retinal degeneration, and increased risks during cataract surgery.
This study introduces a 3D visualization system to enhance the detection rate of LAZ.
By integrating multiple imaging modalities, it systematically assesses the morphological characteristics of LAZ, aiming to provide an evidence-based foundation for subsequent efforts to establish diagnostic consensus, optimize preoperative assessments for glaucoma and cataract surgery.
By elucidating the genetic mechanisms and genotype-phenotype correlations of LAZ, this research can provide theoretical support for the early identification of high-risk populations, genetic consultation, and personalized treatment.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350007
- Fuzhou Eye Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
LAZ (Long anterior zonules) is characterized by the abnormal anterior extension of the ciliary zonule fibers, resulting in a significant reduction in the diameter of the central zonule-free zone of the lens.
Description
Inclusion Criteria:
- Control Group Routine cataract patient, no signs of LAZ, intraocular pressure ≤21 mmHg, and no history of glaucoma, pigment dispersion syndrome, or other eye diseases that clearly affect the anterior segment structure.
- LAZ Group Patients with cataracts combined with LAZ were independently evaluated by at least two senior ophthalmologists under slit-lamp examination or a 3D visualization system, and were required to meet the predefined diagnostic criteria for LAZ.
- LAZ Pedigree Cohort First-degree and above relatives of the LAZ proband, aged ≥18 years, regardless of the presence or absence of LAZ or related ocular disease phenotypes.
Exclusion Criteria:
- Secondary glaucoma with a clear etiology (such as inflammatory, traumatic, or neovascular glaucoma, etc.)
- History of previous intraocular surgery (e.g., cataract, glaucoma, or vitreoretinal surgery), with refractive surgery history documented but analyzed with caution
- Presence of ocular conditions affecting anterior segment imaging quality, such as corneal leukoma or severe cataract
- Individuals with severe systemic diseases (e.g., poorly controlled diabetes, connective tissue diseases) or mental disorders that hinder cooperation during examinations
- Pregnant or lactating women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control Group
|
Routine cataract patient, no signs of LAZ, intraocular pressure ≤21 mmHg, and no history of glaucoma, pigment dispersion syndrome, or other eye diseases that clearly affect the anterior segment structure.
|
|
LAZ Group
|
Patients with cataracts combined with LAZ were independently evaluated by at least two senior ophthalmologists under slit-lamp examination or a 3D visualization system, and were required to meet the predefined diagnostic criteria for LAZ.
|
|
LAZ Pedigree Cohort
|
First-degree and above relatives of the LAZ proband, aged ≥18 years, regardless of the presence or absence of LAZ or related ocular disease phenotypes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Axial length
Time Frame: 1 day pre-op
|
Axial length, anterior chamber depth, lens thickness, corneal curvature, corneal diameter
|
1 day pre-op
|
|
Anterior chamber depth
Time Frame: 1 day pre-op
|
1 day pre-op
|
|
|
Lens thickness
Time Frame: 1 day pre-op
|
1 day pre-op
|
|
|
Corneal curvature
Time Frame: 1 day pre-op
|
1 day pre-op
|
|
|
Corneal diameter (WTW)
Time Frame: 1 day pre-op
|
1 day pre-op
|
|
|
Imaging of LAZ morphology and distribution
Time Frame: 1 day pre-op
|
The images and videos about slit lamp and 3D visualization system.
|
1 day pre-op
|
|
Gene sequencing
Time Frame: through study completion, an average of 1 year
|
Identification of pathogenic genes
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Uncorrected Visual Acuity (UCVA)
Time Frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
|
1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
|
|
|
Corrected Distance Visual Acuity (CDVA)
Time Frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
|
1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
|
|
|
Spherical equivalent (SE)
Time Frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
|
1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
|
|
|
Intraocular pressure
Time Frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
|
1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
|
|
|
Intraoperative complications
Time Frame: Intraoperative
|
Intraoperative capsular complications occur
|
Intraoperative
|
|
Age
Time Frame: 1 day pre-op
|
1 day pre-op
|
|
|
Sex
Time Frame: 1 day pre-op
|
1 day pre-op
|
|
|
Diagnosis
Time Frame: 1 day pre-op
|
Diagnosis of accompanying ocular and systemic conditions, such as glaucoma, macular degeneration, hypertension, diabetes, etc.
|
1 day pre-op
|
|
Anterior chamber volume (ACV)
Time Frame: 1 day pre-op
|
1 day pre-op
|
|
|
Anterior chamber area (ACA)
Time Frame: 1 day pre-op
|
1 day pre-op
|
|
|
Angle opening distance (AOD)
Time Frame: 1 day pre-op
|
1 day pre-op
|
|
|
Trabecular iris angle (TIA)
Time Frame: 1 day pre-op
|
1 day pre-op
|
|
|
Images of the ciliary body structure
Time Frame: 1 day pre-op
|
Images of the ciliary body captured by UBM
|
1 day pre-op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
April 9, 2026
First Submitted That Met QC Criteria
April 17, 2026
First Posted (Actual)
April 24, 2026
Study Record Updates
Last Update Posted (Actual)
April 24, 2026
Last Update Submitted That Met QC Criteria
April 17, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- FZYKYY-KY-2025-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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