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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control Group
Genetic: Control
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
Genetic: Long anterior zonules
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
Genetic: LAZ Pedigree
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fuzhou Eye Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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