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临床试验/NCT04019691
NCT04019691已完成不适用

Comparing the Visual Outcome, Visual Quality, and Satisfaction Among Three Types of Multi-focal Intraocular Lenses

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年8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
60
试验地点
1
主要终点
Postoperative contrast sensitivity in the three groups.

研究概览

简要总结

The investigators are going to Investigate the comparative efficacy of the patients who underwent cataract surgery with three different multifocal IOLs.

详细描述

Going to analyze the clinical results of 60 patients who underwent bilateral cataract surgery and multifocal IOL implantation. The patients were divided into the following three groups: Mix-and-Match, EDOF, and Trifocal. The clinical assessments included uncorrected near, intermediate, distance and best corrected distance visual acuity, defocus curves, contrast sensitivity, and reading speed. Patient satisfaction was evaluated by questionnaire. All outcomes were compared among the three groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients with bilateral senile cataracts and the desire to be spectacle-free for all distances

排除标准

  • Patients younger than 21 years, had corneal astigmatism >1.00 D, previous ocular surgery or trauma, or ocular disease other than cataracts

结局指标

主要结局

Postoperative contrast sensitivity in the three groups.

时间窗: Postoperative 3 months

3, 6, 12, and 18 cycles per degree using a CSV-1000 chart (Vector Vision, reenville, OH) under photopic (85 cd/m2), mesopic (\~3 cd/m2), and mesopic with glare conditions

Postoperative uncorrected near, intermediate, and far visual acuity.

时间窗: At 1month and 3months after surgery

logMAR

Postoperative satisfaction questionnaire.

时间窗: Postoperative 3 months

patients were shown images and asked to rate the frequency, degree, and discomfort related to the visual artifacts as none, minimal, moderate, or severe (0, 1, 2, or 3 points for the respective levels). The mean score was calculated.

次要结局

  • Postoperative refractive outcome(Postoperative 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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