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Enrolling by invitation NCT07549711

Morphological-Gene-Clinical Phenotype Correlation Study of the Long Anterior Zonule

— Observational Long Anterior Zonules

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control, Long anterior zonules, LAZ Pedigree.
Who it may be relevant to
Registry conditions: Long Anterior Zonules. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Morphological, Genetic, and Clinical Phenotype Association Study of the Long Anterior Zonule (LAZ) Based on Multimodal Imaging and Genetic Testing

Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Axial length [Time frame: 1 day pre-op]
  • Anterior chamber depth [Time frame: 1 day pre-op]
  • Lens thickness [Time frame: 1 day pre-op]
  • Corneal curvature [Time frame: 1 day pre-op]
  • Corneal diameter (WTW) [Time frame: 1 day pre-op]
  • Imaging of LAZ morphology and distribution [Time frame: 1 day pre-op]
  • Gene sequencing [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (12)
  • Uncorrected Visual Acuity (UCVA) [Time frame: 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]
  • Spherical equivalent (SE) [Time frame: 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]
  • Intraoperative complications [Time frame: Intraoperative]
  • Age [Time frame: 1 day pre-op]
  • Sex [Time frame: 1 day pre-op]
  • Diagnosis [Time frame: 1 day pre-op]
  • Anterior chamber volume (ACV) [Time frame: 1 day pre-op]
  • Anterior chamber area (ACA) [Time frame: 1 day pre-op]
  • Angle opening distance (AOD) [Time frame: 1 day pre-op]
  • Trabecular iris angle (TIA) [Time frame: 1 day pre-op]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Fuzhou Eye Hospital — Fuzhou

Identifiers

NCT: NCT07549711 · FZYKYY-KY-2025-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗