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临床试验/NCT03447041
NCT03447041已完成不适用

Zhongshan Ophthalmic Center, Sun Yat-Sen University,China

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
The contrast sensitivity function tested by quick CSF in the keratoplasty group

研究概览

简要总结

This study is to inquiry the contrast sensitivity function in the 50 eyes of limbal dermoid children with keratoplasty with quick contrast sensitivity function (quick CSF) test, as well asa to analyze its relationship between visual quality.

详细描述

Limbal dermoid(LD) is a congenital benign tumor that consist of overgrowths of epidermal appendages that influence vision and cause visual abnormalities due to the induced corneal astigmatism. A large proportion of patients, all of whom had epibular dermoids, has amblyopia. In a previous study, keratoplasty, such as LKP (Lamellar Keratoplasty) or PKP (Penetrating Keratoplasty), was shown to facilitate the reconstruction of appearance, and improve visual acuity significantly postoperatively. However, the reestablishment of visual acuity and visual function are always ignored by parents after visual appearance recovery. Several studies have evaluated the visual acuity and objective and subjective visual function of patients after keratoplasty. These outcomes include contrast sensitivity (CS), refractive error, graft clarity, anterior and posterior corneal higher order aberration, and vision-related quality of life. Although a subjective visual function assessment has been deemed critical, postkeratoplasty patients with vision complaints are not uncommon despite clear grafts and relatively good visual acuity, and the visual function evaluation for LD were relatively less.

50 eyes of 50 limbal dermoid children with corneal transplantation more than 1 year were included in this study. All participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick CSF under full optical correction, 9-SF life quality questionnaire and fundus examination. Then the normal group would be covered by the positive spherical lens of 1.0D to 6.0D to repress the BCVA to 0.1 to 0.9 respectively to compare the visual functions with the keratoplasty patients on the same visual acuity.

研究设计

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

入排标准

年龄范围
7 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Accept the corneal transplantation based on the clinical diagnosis of ocular surface disease;
  • more than 7 and less than 60 years old;
  • absence of other ocular disorders and no history of eye surgery and other systemic diseases.

排除标准

  • less than 7 or more than 60 years old;
  • with the history of eye surgery and other systemic diseases.

结局指标

主要结局

The contrast sensitivity function tested by quick CSF in the keratoplasty group

时间窗: on 1 year postkeratoplasty

The quick CSF (contrast sensitivity function) tests including AULCSF (the area under the log CSF) and Cutoff SF (Cutoff sensitivity function)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin Yuan

Yuanjin PI group

Zhongshan Ophthalmic Center, Sun Yat-sen University

研究点 (1)

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