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临床试验/NCT07549711
NCT07549711Enrolling By Invitation不适用

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

Fuzhou Eye Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
600
试验地点
1
主要终点
Corneal curvature

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Control Group

干预措施: Control (Genetic)

LAZ Group

干预措施: Long anterior zonules (Genetic)

LAZ Pedigree Cohort

干预措施: LAZ Pedigree (Genetic)

结局指标

主要结局

Corneal curvature

时间窗: 1 day pre-op

Corneal diameter (WTW)

时间窗: 1 day pre-op

Axial length

时间窗: 1 day pre-op

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

Anterior chamber depth

时间窗: 1 day pre-op

Lens thickness

时间窗: 1 day pre-op

Imaging of LAZ morphology and distribution

时间窗: 1 day pre-op

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

Gene sequencing

时间窗: through study completion, an average of 1 year

Identification of pathogenic genes

次要结局

  • Trabecular iris angle (TIA)(1 day pre-op)
  • 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)
  • Age(1 day pre-op)
  • Sex(1 day pre-op)
  • Diagnosis(1 day pre-op)
  • Anterior chamber volume (ACV)(1 day pre-op)
  • Anterior chamber area (ACA)(1 day pre-op)
  • Angle opening distance (AOD)(1 day pre-op)
  • Images of the ciliary body structure(1 day pre-op)

研究者

发起方
Fuzhou Eye Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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