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临床试验/NCT05085314
NCT05085314已完成不适用

Prospective Multicenter Randomized Controlled 1:1 Study Evaluating the Efficacy of a 3D Digital Operating Microscope Compared to Conventional Microscopes Microscopes on the Comfort and Subjective Visual Sensations of the Patients Related to the Microscope Light During Initial Cataract Surgery Under Topical Anesthesia Topical Anesthesia

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2021年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
2
主要终点
Glare of patients related to the light of the microscope of the patients

研究概览

简要总结

Digital 3D microscopes require less light and may be more comfortable for patients requiring cataract surgery under topical anesthesia compared to conventional microscopes.

To date, no studies have evaluated the comfort and subjective visual sensations related to the light of the 3D digital microscope in cataract surgery patients.

The purpose of this study is to evaluate the effectiveness of the Ngenuity 3D digital operating system (Alcon, Fort Worth, TX) compared to conventional microscopes on the comfort and subjective visual sensations related to of patients undergoing initial cataract surgery under topical anesthesia (pure or combined with intravenous sedation).

详细描述

Patients will be recruited during the preoperative consultation where the indication for cataract surgery. The allocation of the management arm (3D digital microscope or conventional microscope) will be randomized in a stratified way on the center.

Prior to his or her operative session, the surgeon will set up the microscope with his or her usual parameters.

The light intensity will be measured at the beginning of the operating session with a calibrated light meter. The type of anesthesia (pure topical or associated with intravenous sedation), the duration of the operation, intraoperative complications (frequency and type), and the possible use of an anesthesiologist to inject additional intravenous anesthetic will be collected.

Before the patient is discharged from the ambulatory surgical unit, the clinical study technician will ask the patient the 4 questions of the standardized questionnaire assessing comfort and subjective visual sensations related to the microscope light.

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)

入排标准

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

入选标准

  • •Indication for a first surgery (= first eye to be operated) of cataract alone under topical anesthesia (pure or associated with intravenous sedation)
  • •Express consent to participate in the study

排除标准

  • •Patient benefiting from a legal protection measure
  • •Patient with comprehension problems or who does not understand French well
  • •Pregnant or breastfeeding woman
  • •Indication for another surgery on the operated side (e.g. vitrectomy combined with cataract surgery)

研究组 & 干预措施

Ngenuity digital 3D microscope

Experimental

干预措施: Ngenuity digital 3D microscope (Procedure)

Conventional microscope

Active Comparator

干预措施: Conventional microscope (Procedure)

结局指标

主要结局

Glare of patients related to the light of the microscope of the patients

时间窗: two hours maximum after surgery

Patient response to the question "Were you dazzled by light during surgery?" rated on a numerical scale from 0 (Not at all) to 10 (Yes, very much)

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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