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临床试验/NCT04982107
NCT04982107已完成不适用

Pupil Influence on the Quality of Vision in Implantable Collamer Lens (ICL)

He Eye Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年7月1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
70
试验地点
1
主要终点
Subjective Quality of vision

研究概览

简要总结

The aim of this study is to observe the influence of pupil size upon visual outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation.

详细描述

The aim of this study is to observe the influence of pupil size upon the quality of vision outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation. Pre-operation and 3-month post-operation pupil size, visual acuity, quality of vision will be evaluated in patient that had ICL surgery.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Myopic eyes
  • Preoperative corneal endothelial cell count ≥2200/mm2
  • Preoperative central anterior chamber depth> 2.80mm
  • Intraocular pressure within the normal range (10-21mmHg)

排除标准

  • Severe dry eye
  • Cataract and glaucoma
  • Patients with uveitis
  • Retinal detachment
  • Patients with autoimmune diseases
  • Patients with systemic diseases such as diabetes and hypertension
  • Patients with mental or cognitive abnormalities

结局指标

主要结局

Subjective Quality of vision

时间窗: Baseline (before surgery) and 3 month after surgery

Change in QoV questionnaire score after ICL surgery at 3-month testing will be compare with baseline measurements

Pupil diameter pre-operation and post-operation

时间窗: Baseline (before surgery) and 3 month after surgery

Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements

Wave front aberrometry

时间窗: baseline and 3 month after surgery

Change in Wave front aberrometry after ICL surgery at 3-month testing will be compare with baseline measurements

Point Spread Function (PSF)

时间窗: baseline and 3 month after surgery

Change in Point Spread Function (PSF) after ICL surgery at 3-month testing will be compare with baseline measurements

Modulation transfer function (MTF)

时间窗: Baseline and 3 month after surgery

Change in Modulation transfer function after ICL surgery at 3-month testing will be compare with baseline measurements

Strehl ratio

时间窗: Baseline and 3 month after surgery

Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements

次要结局

未报告次要终点

研究者

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

研究点 (1)

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