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Enrolling by Invitation

NCT Number: NCT07549711

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuzhou Eye Hospital

Fuzhou, Fujian, 350007, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Genetic

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.

Long anterior zonules

Genetic

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

Genetic

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 outcomes

  1. Axial length

    Time frame: 1 day pre-op

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

  2. Anterior chamber depth

    Time frame: 1 day pre-op

  3. Lens thickness

    Time frame: 1 day pre-op

  4. Corneal curvature

    Time frame: 1 day pre-op

  5. Corneal diameter (WTW)

    Time frame: 1 day pre-op

  6. Imaging of LAZ morphology and distribution

    Time frame: 1 day pre-op

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

  7. Gene sequencing

    Time frame: through study completion, an average of 1 year

    Identification of pathogenic genes

Secondary outcomes

  1. Uncorrected Visual Acuity (UCVA)

    Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

  2. Corrected Distance Visual Acuity (CDVA)

    Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

  3. Spherical equivalent (SE)

    Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

  4. Intraocular pressure

    Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

  5. Intraoperative complications

    Time frame: Intraoperative

    Intraoperative capsular complications occur

  6. Age

    Time frame: 1 day pre-op

  7. Sex

    Time frame: 1 day pre-op

  8. Diagnosis

    Time frame: 1 day pre-op

    Diagnosis of accompanying ocular and systemic conditions, such as glaucoma, macular degeneration, hypertension, diabetes, etc.

  9. Anterior chamber volume (ACV)

    Time frame: 1 day pre-op

  10. Anterior chamber area (ACA)

    Time frame: 1 day pre-op

  11. Angle opening distance (AOD)

    Time frame: 1 day pre-op

  12. Trabecular iris angle (TIA)

    Time frame: 1 day pre-op

  13. Images of the ciliary body structure

    Time frame: 1 day pre-op

    Images of the ciliary body captured by UBM

Sponsors and collaborators

Lead sponsor

Fuzhou Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.