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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2024年1月1日

概览

阶段
不适用
干预措施
Visual Acuity Assessment
疾病 / 适应症
Presbyopia
发起方
Democritus University of Thrace
入组人数
40
试验地点
1
主要终点
Area of the curve (AOC) assessment
状态
已完成
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2024年1月1日
结束日期
2024年12月31日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Democritus University of Thrace

入排标准

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

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

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

研究点 (1)

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