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临床试验/NCT04985097
NCT04985097已完成不适用

Preliminary Evaluation of the Clinical Benefit of a Novel Visual Rehabilitation System in Patients Implanted With Trifocal Diffractive Intraocular Lenses: A Blinded Randomized Placebo-controlled Clinical Trial

Increase-Tech2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Visual acuity

研究概览

简要总结

This multicentre randomised controlled trial aimed to reduce the visual discomfort that patients implanted with trifocal diffractive intraocular lenses may experience after surgery. To this end, a visual training software (Optictrain) was developed in which Gabor patches were presented to the patient on a hand-held electronic device. Patients who met all inclusion criteria and consented to participate underwent half an hour of visual training per day for a period of 20 consecutive days remotely on a colourimetrically characterised Samsung Galaxy Tab A device on which the Optictrain software (n=30) or a placebo software (n=30), respectively, was pre-installed. Corrected and uncorrected near, intermediate and distance visual acuity (VA) and mesopic near and distance contrast sensitivity (CS) were measured monocularly and binocularly at two visits: during the first postoperative week (V0) and after 20 days of visual training with the assigned software (V1). The statistical analysis of the results obtained in the study has not yet been carried out.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 an 90 years
  • Patients implanted with trifocal diffractive intraocular lenses
  • Availability and motivation to perform the visual training assigned

排除标准

  • Age under 18 or over 90 years
  • Presence of irregular cornea, illiteracy or cognitive impairment
  • History of eye surgery or presence of any active ocular disease
  • Intraoperative complications leading to significant visual sequelae
  • Patients implanted with monofocal, extended depth of focus or refractive multifocal IOLs

结局指标

主要结局

Visual acuity

时间窗: During the first post-operative week and after 20 days of vision training with the randomly assigned software

Monocular and binocular corrected and uncorrected visual acuity under near, intermediate and distance conditions

Contrast sensitivity

时间窗: During the first post-operative week and after 20 days of vision training with the randomly assigned software

Monocular and binocular mesopic contrast sensitivity under near and distance conditions

次要结局

未报告次要终点

研究者

发起方
Increase-Tech
申办方类型
Other
责任方
Sponsor

研究点 (2)

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