NCT07549711

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jan 2025Dec 2028

Study Start

First participant enrolled

January 10, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

April 9, 2026

Last Update Submit

April 17, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • Axial length

    Axial length, anterior chamber depth, lens thickness, corneal curvature, corneal diameter

    1 day pre-op

  • Anterior chamber depth

    1 day pre-op

  • Lens thickness

    1 day pre-op

  • Corneal curvature

    1 day pre-op

  • Corneal diameter (WTW)

    1 day pre-op

  • Imaging of LAZ morphology and distribution

    The images and videos about slit lamp and 3D visualization system.

    1 day pre-op

  • Gene sequencing

    Identification of pathogenic genes

    through study completion, an average of 1 year

Secondary Outcomes (13)

  • Uncorrected Visual Acuity (UCVA)

    1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

  • Corrected Distance Visual Acuity (CDVA)

    1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

  • Spherical equivalent (SE)

    1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

  • Intraocular pressure

    1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

  • Intraoperative complications

    Intraoperative

  • +8 more secondary outcomes

Study Arms (3)

Control Group

Genetic: Control

LAZ Group

Genetic: Long anterior zonules

LAZ Pedigree Cohort

Genetic: LAZ Pedigree

Interventions

ControlGENETIC

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.

Control 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 Group

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.

LAZ Pedigree Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuzhou Eye Hospital

Fuzhou, Fujian, 350007, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

anterior lens capsule, peripheral venous blood

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 24, 2026

Study Start

January 10, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations