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临床试验/NCT06704503
NCT06704503招募中不适用

To Study the Changes Under Different Accommodation of Anterior Eye in People of Different Ages and 3D Crystal Reconstruction.

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Central corneal thickness changes during accommodation

研究概览

简要总结

Accommodation is defined as a dynamic change in the overall refractive power of the eye during near fixation. Despite extensive investigations, the exact nature of human accommodation remains controversial. And recent alternative theories question the original concept of accommodation.Different experts have put forward different hypotheses. The age-related changes that underlie presbyopia are also not fully understood.Because of these unanswered questions, the topic of regulation and presbyopia remains a focus of research.

详细描述

Accommodation is the process by which the eye changes the shape and diopter of the lens to obtain a clear image of an object at different distances. Despite extensive research on regulation, the exact nature of human regulation remains controversial. Age-related changes in presbyopia are also not fully understood. Some studies have shown that a hardening of the lens and an increase in the thickness and diameter of the lens with age can lead to presbyopia. Others believe that the main cause is external lens factors, such as age-related changes in the Angle of lens suspension ligament attachment, reduced ciliary body movement, etc. Due to these unanswered questions, the topic of regulation and presbyopia remains the focus of research. In living humans, modulation studies utilize different imaging modes, and ultrasound biomicroscopy (UBM) and Optical Coherence Tomography(OCT) are particularly important in studying anterior segments and modulation. However, UBM is a contact inspection and requires highly skilled technicians. And UBM cannot image the entire anterior segment in a single capture. Anterior segment OCT (AS-OCT), on the other hand, is non-invasive and provides higher resolution imaging, allowing us to capture the morphology of the anterior segment structures in different populations and the changes of the anterior segment structures in response to regulatory stimuli. Studies have shown that with age, reduced anterior chamber depth, pupil contraction, increased lens thickness, increased lens arch height, and loss of posterior ciliary muscle contraction may be biomarkers of early presbyopia. In this study, anterior segment OCT was used to explore whether there were differences in the structural morphology of the anterior segment in people of different ages, and what changes occurred in the structure of the anterior segment after initiation of regulation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • · Patients with astigmatism ≤-1.50D and best corrected visual acuity ≥4.9

排除标准

  • Patients with other systemic diseases
  • Patients with a history of eye surgery
  • Patients with intraocular lens or aphakia
  • Patients with strabismus and amblyopia
  • Pregnant or lactating women
  • People with mental disorders or neurological diseases who cannot cooperate with the examination

结局指标

主要结局

Central corneal thickness changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

Central corneal thickness CCT(μm)

anterior chamber depth changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

anterior chamber depth ACD(mm)

peripheral corneal thickness changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

peripheral corneal thickness(μm)

anterior chamber Angle Angle changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

anterior chamber Angle Angle ACA(°)

anterior opening distance changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

anterior opening distance AOD(mm)

pupil size changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

pupil size PD(mm)

lens sagittal height changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

lens sagittal height(mm)

anterior chamber volume changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

anterior chamber volume(mm³)

lens thickness changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

lens thickness LT(mm)

anterior and posterior surface curvature radius changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

anterior and posterior surface curvature radius(mm)

lens arch height changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

lens arch height LV(mm)

posterior chamber volume changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

posterior chamber volume(mm³)

crystal equatorial diameter changes during accommodation

时间窗: Baseline, after accommodation(30 minutes after using pilocarpine)

crystal equatorial diameter(mm)

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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