跳至主要内容
临床试验/NCT06015334
NCT06015334尚未招募不适用

Applying Virtual Reality to Compare Visual Performance Following Bilateral Implantation of TECNIS Synergy vs TECNIS Monofocal Intraocular Lens With Monovision in Patients With Cataract: A Randomized Controlled Trial.

The University of Hong Kong0 个研究点目标入组 114 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
114
主要终点
Overall Virtual reality (VR) performance score

研究概览

简要总结

The proposed randomized clinical trial aims to compare visual performance, measured using VR simulations, in cataract patients implanted either with bilateral trifocal IOL or bilateral monofocal IOL with monovision. The hypothesis is that patients implanted with trifocal IOL would exhibit superior visual performance, in both daytime and nighttime conditions, compared to those with a monofocal IOL with monovision.

详细描述

Cataract surgery provides an opportunity to restore the quality of life by improving vision. While monofocal intraocular lenses (IOLs) implantation with monovision has been a common approach for cataract surgery, it may result in limited clarity at the intermediate distance and reduced depth perception. The advent of multifocal IOLs has expanded the possibilities, potentially offering increased visual performance in different ranges of vision. However, the benefits of multifocal IOLs in everyday activities are not fully understood due to the lack of task-based investigations.

To address this gap, a virtual reality-based approach is proposed to simulate daily activities and assess visual performance. This innovative method can provide insights into how multifocal IOLs enhance activities requiring good binocular vision at varying distances, a capability monofocal IOLs may lack. A randomized clinical trial is suggested to compare the TECNIS Synergy multi-focal IOL with the TECNIS monofocal IOL in monovision. Unlike its bifocal predecessors, the TECNIS Synergy IOL is trifocal, providing clear vision at near, intermediate, and far distances. The hypothesis is that patients implanted with the TECNIS Synergy IOL will demonstrate superior visual performance in simulated day and night conditions compared to those implanted with monofocal IOLs and monovision.

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
Single (Participant)

盲法说明

Patients will remain unaware of their specific study arm assignments until the completion of the study.

入排标准

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

入选标准

  • Bilateral cataract
  • Regular corneal astigmatism
  • Corneal endothelium cell count >2000 cells/mm2
  • Clear intraocular media other than cataract

排除标准

  • Concomitant ocular diseases
  • Irregular corneal aberration
  • Capsular instability
  • Systemic disease that may affect vision
  • History of other intraocular surgery

结局指标

主要结局

Overall Virtual reality (VR) performance score

时间窗: Pre-operation, Month3

VR performance score measured from all VR simulations

次要结局

  • Binocular reading speed assessment(Pre-operation, Month3)
  • Intermediate (66 cm) visual acuity(Month3)
  • Task-specific VR performance score(Pre-operation, Month3)
  • Binocular contrast sensitivity(Pre-operation, Month3)
  • Near (40 cm) visual acuity(Month3)
  • Distance visual acuity(Pre-operation, Day1, Week1, Month1, Month3)
  • Binocular defocus curve(Month3)
  • Photic phenomena(Pre-operation, Month3)
  • Quality of life assessment(Pre-operation, Month3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Christopher K.S. Leung

Clinical Professor

The University of Hong Kong

相似试验