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临床试验/NCT05207007
NCT05207007已完成不适用

Visual Function in Pediatric Patients With Posterior Polar Cataracts and Posterior Lenticonus

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2020年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Stereoacuity

研究概览

简要总结

Prognostic factors determining visual outcomes in patients with posterior polar cataracts and posterior lenticonus are largely unknown. In this trial, the investigators aimed to evaluate the visual outcomes in patients with posterior polar cataracts and posterior lenticonus and try to find out the factors associated with the visual acuity after surgery. Patients enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.

详细描述

Congenital cataract patients have a wide range of presentations of lens opacities with different impact on visual function. Polar cataracts are opacities of the subcapsular cortex in the polar regions of the lens. To our knowledge, anterior polar cataracts are usually visually insignificant, however, even a small posterior lens opacity can impair vision because of their close proximity to the macula. Visual impairment could be caused by an opacity that blocks the visual axis, refractive error, posterior lesion-induced optical distortion, or amblyopia. Therefore, surgery is often recommended when visual function is significantly affected. The primary indication for surgical intervention in cataract is poor visual acuity. However, the previous studies have shown that preoperative visual acuity is a poor predictor of improvement in the subjectively experienced quality of vision after cataract surgery. Considering the increased risk for capsule rupture during surgery and the sacrifice of accommodation after cataract surgery in eyes with posterior lens opacities, the decision of surgical intervention must be carefully weighed.

In this trial, the investigators aimed to evaluate the changes of visual function, including visual acuity, modulation transfer function, ocular aberrations in the participants with posterior lens opacities. Moreover, various factors which might be associated with postoperative visual acuity were explored. The participants enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with posterior polar cataracts or posterior lenticonus who need cataract surgery
  • Aged 3-14 years
  • Have signed a consent form
  • Can be followed

排除标准

  • Have relevant ocular disease other than congenital cataract
  • Could not cooperate to the examinations

结局指标

主要结局

Stereoacuity

时间窗: 6 month after surgery

Stereoacuity measured at 40 cm using the Randot stereotests

modulation transfer function (MTF)

时间窗: 6 month after surgery

MTF measured with the Optical Quality Analysis System

monochromatic aberrations

时间窗: 6 month after surgery

monochromatic aberrations measured by the iTrace Dynamic Laser Refraction

Visual acuity (BCVA)

时间窗: 6 month after surgery

Visual acuity (BCVA) measured by ETDRS chart after surgery

次要结局

  • Location of the cataracts(before surgery)
  • size of lens lesion(before surgery)
  • Visual acuity (BCVA)(before surgery)
  • Stereoacuity(before surgery)
  • modulation transfer function (MTF)(before surgery)
  • monochromatic aberrations(before surgery)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haotian Lin

Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center

Sun Yat-sen University

研究点 (1)

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