跳至主要内容
临床试验/NCT05411341
NCT05411341已完成不适用

Assessment of Two Different Optical Biometric Systems, Based on Different Optical Technologies in Patients With Cataract or Presbyopia

Democritus University of Thrace1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2023年7月1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
133
试验地点
1
主要终点
Keratometry values

研究概览

简要总结

Primary objective of this study is to evaluate and compare the measurements of two different optical biometrics systems in patients who will undergo cataract surgery or presbyopia surgery using intraocular lenses (IOL-PC).

详细描述

This is a prospective study including patients visiting the outpatient Ophthalmology clinic of the University General Hospital of Alexandroupolis, who suffer from diagnosed cataract or presbyopia and are going to undergo implantation of intraocular lenses surgery. The patients will be fully informed about the procedure and the purpose of the study and a written informed consent will be provided by all participants. They will then undergo an ocular biometry examination using two optical biometric systems, Argos (Alcon Laboratories, Inc.) and IOLMaster 500 (Carl Zeiss Meditec AG). IOL Master 500 (Carl Zeiss Meditec AG) is a non-invasive optical biometer that uses partial coherence interferometry (PCI) with a wavelength of 780 nm to measure the AL of the eye. Argos (Alcon Laboratories, Inc.) is a novel non-invasive optical biometer that uses swept source optical coherence tomography (SS-OCT) with a wavelength of 1050 nm. The measurements of the two systems that will be compared are the axial length, the keratometry values, the anterior chamber depth (ACD), the horizontal corneal diameter (white to white [WTW]) and the lens power in diopters (D).

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with cataract and/or presbyopia who will undergo intraocular lens implantation.

排除标准

  • Dense cataract that does not allow measurements to be taken with an optical biometrics system.

研究组 & 干预措施

Study Group

100 patients with diagnosed cataract or presbyopia who will undergo implantation of intraocular lenses surgery

干预措施: Argos (Alcon Laboratories, Inc.) (Device)

Study Group

100 patients with diagnosed cataract or presbyopia who will undergo implantation of intraocular lenses surgery

干预措施: IOLMaster 500 (Carl Zeiss Meditec AG) (Device)

结局指标

主要结局

Keratometry values

时间窗: 1 week

The measurement of keratometry values K1: flat meridian of the anterior corneal surface and K2: steep meridian of the anterior corneal surface of the affected eye using both devices.

Lens power (D)

时间窗: 1 week

The power of the lens is calculated by each device as a function of biometric measurements

Axial length

时间窗: 1 week

The measurement of the axial length of the affected eye using both devices

次要结局

  • Horizontal corneal diameter (white to white [WTW])(1 week)
  • Anterior chamber depth (ACD)(1 week)

研究者

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

Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Democritus University of Thrace

研究点 (1)

Loading locations...

相似试验