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临床试验/NCT06460389
NCT06460389已完成不适用

Comparison of Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance

Democritus University of Thrace1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Area of the curve (AOC) assessment

研究概览

简要总结

The primary objective of this study is to compare the postoperative visual acuity curves of patients that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.

详细描述

This is a prospective, comparative study of 60 patients diagnosed with grade 2 cataracts (according to LOCS III) that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.

In these patients, a comparison of postoperative visual acuity curves of both groups will be conducted. Visual acuity curves will be designed using the validated digital optotype Democritus Digital Acuity & Reading Test (DDART). Assessment of visual acuity will be performed at 9 different distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Overall visual acuity curves and the area under the curve will be formed through the application as the primary means of evaluating visual capacity. Additionally, the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25). All examinations will be conducted according to standard clinical practice.

研究设计

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

入排标准

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

入选标准

  • Diagnosis of grade 2 cataracts (according to LOCS III)
  • age >45 years.

排除标准

  • Inability to understand the Greek language and respond to the interview
  • conditions of the posterior or corneal segment
  • previous intraocular surgery

研究组 & 干预措施

Insertion of an extended depth of focus intraocular lens with digital assistance

Participants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens with digital assistance

干预措施: Visual Acuity Assessment (Diagnostic Test)

Insertion of an extended depth of focus intraocular lens without digital assistance

Participants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens without digital assistance

干预措施: Visual Acuity Assessment (Diagnostic Test)

结局指标

主要结局

Area of the curve (AOC) assessment

时间窗: 4 months

Calculation of the AOC as a visual outscome measure

the degree of subjective satisfaction of the patient

时间窗: 4 months

the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25)

Visual acuity assessment

时间窗: 4 months

Visual acuity assessment in 9 focal points using DDART chart

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

Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Democritus University of Thrace

研究点 (1)

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