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临床试验/NCT05594537
NCT05594537尚未招募不适用

The Best Way to Improve the Near Visual Acuity After Implantation of Tecnis Symfony® ZXR00 Intraocular Lens

Yune Zhao0 个研究点目标入组 30 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
Uncorrected Visual Acuities

研究概览

简要总结

The Best Way to Improve the Near Visual Acuity After ZXR00 IOL Implantation

详细描述

ZXR00 intraocular lens is a new type of IOL that can achieve good continuous visual acuity. Its characteristic is to improve the distance and intermedia visual acuity and maintain good visual quality while sacrificing the near visual acuity. Previous studies report that there are mainly two ways to improve the near visual acuity of ZXR00:1.Bilateral implantation of ZXR00 with micromonovision. 2. Combined Implantation of ZXR00 and multifocal IOLs.This study aim to explore which is the best way to improve the near visual acuity after ZXR00 IOL implantation.

研究设计

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

入排标准

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

入选标准

  • Age of 18-80 years
  • Cataract surgery is planned
  • The operation was successful without any complications
  • Implanted with ZXR00 IOLS or ZMB00 IOLs

排除标准

  • The history of retinopathy or retinal surgery
  • Irregular corneal astigmatism
  • Regular corneal astigmatism of 1.00 diopter (D) or more
  • Iris abnormalities
  • Macular degeneration
  • Neuro-ophthalmic disease
  • The history of ocular inflammation

结局指标

主要结局

Uncorrected Visual Acuities

时间窗: 2022.12.31

Uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm).

Patient satisfaction

时间窗: 2022.12.31

Patient satisfaction was rated on a scale of 1 to 5: 1 = very dissatisfied; 2 = dissatisfied; 3 = neutral; 4 = satisfied; and 5 = very satisfied.

Subjective quality of vision

时间窗: 2022.12.31

Subjective quality of vision was evaluated using the 14-item Visual Function Questionnaire (VFQ-14).Each item was scaled according to the degree of difficulty of different activities: 4 points (no difficulty), 3 points (a little difficulty), 2 points (a moderate amount of difficulty), 1 point (a great deal of difficulty), and 0 point (unable to do the activity).overall score is range 0-56.The higher the score, the worse subjective quality of vision.

Adverse visual symptoms

时间窗: 2022.12.31

Adverse visual symptoms including blurred vision, glare, starbursts, haloes, hazy vision, distortion, focusing diffculties, multiple images, and depth perception diffculty, was evaluated using the Quality of Vision test. This test includes 30 items, with a score between 0 and 3 (overall score range 0-90).The higher the score, the more postoperative adverse visual symptoms.

Corrected Visual Acuities

时间窗: 2022.12.31

Corrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm).

Stereopsis

时间窗: 2022.12.31

Stereopsis was evaluated using OCULUS Binoptometer.

Defocus Curve

时间窗: 2022.12.31

Corrected monocular and binocular defocus curves were measured from +2.5 D to -4.0 D (in 0.5 D steps).

次要结局

未报告次要终点

研究者

发起方
Yune Zhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Wenzhou Medical University

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