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临床试验/NCT05427526
NCT05427526已完成不适用

Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年2月14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
90
试验地点
2
主要终点
visual quality

研究概览

简要总结

To determine the surgical outcome and patient satisfaction in patients who underwent AT LARA lens implantation during or after vitrectomy at a relatively young age (around 55 years of age), mostly to treat (urgent) retinal detachment.

详细描述

The surgical outcome is defined as the patient satisfaction determined by patient questionnaires.

  • Visual quality: CatQuest questionnaire
  • Near vision: NAVS questionnaire
  • Glare: APPLES questionnaire

These questionnaires are standardized and validated, although no cut-off values have been determined. Hence, the results drawn from these questionnaires are descriptive only.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients that had a LARA IOL implanted in combination with vitrectomy.
  • patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy.

排除标准

  • Patients with a LARA IOL implanted without concomitant or earlier vitrectomy

结局指标

主要结局

visual quality

时间窗: 2 weeks

Catquest questionnaire measuring activity limitations in daily life due to poor vision

near vision

时间窗: 2 weeks

Near Activity Visual Questionnaire (NAVQ) evaluating the near vision

glare

时间窗: 2 weeks

The Assessment of Photic Phenomena and Lens Effects (APPLES) questionnaire assessing the glare

次要结局

  • Binocular performance(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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