Comparison of Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance
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
- 是
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
Georgios Labiris
Professor (Associate) of Democritus University of Thrace
Democritus University of Thrace
