跳至主要内容
临床试验/CTRI/2023/10/058767
CTRI/2023/10/058767进行中(未招募)不适用

Refractive accuracy & visual outcomes in eyes using Alcon Argos® Biometer

Alcon Laboratories India Pvt Ltd1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年10月17日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
150
试验地点
1
主要终点
The mean absolute error between predicted residual error by Argos® Biometer & post operative spherical equivalent.

研究概览

简要总结

This prospective observational study aims at assessing the refractive accuracy and visual outcomes inpatients that underwent cataract surgery with IOL implantation in which IOL power was obtained using Argos® biometer. The post-operative visual acuity and refractive error will be compared with the preoperative visual acuity and predicted post-operative refractive error on Argos® biometer. The main purpose of this study is to determine if Argos can accurately estimate the IOL power in long and short axial length eyes and provide consistent and accurate post-operative results

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with age related cataract Patients willing to provide consent for study and to come for follow ups as required.

排除标准

  • Patients with prior history of ocular surgery or trauma ii.
  • Patients who underwent complicated cataract surgery or any additional procedures during cataract surgery iii.
  • Patients who had any post-operative complications iv.
  • Patients with any active ocular disease such as Diabetic retinopathy, macular degeneration, glaucoma with field defects and irregular corneal astigmatism v.
  • Patients who is not willing to sign Informed Consent Form for the study.

结局指标

主要结局

The mean absolute error between predicted residual error by Argos® Biometer & post operative spherical equivalent.

时间窗: Screening | Day 1 assessment | Day 30 assessment

次要结局

  • Evaluation of the accuracy of Argos® Biometer in estimating the IOL power in long axial length (26 mm or more) eyes & short axial length (22.5 mm or less) eyes(Screening)

研究者

发起方
Alcon Laboratories India Pvt Ltd
申办方类型
Pharmaceutical industry-Global

研究点 (1)

Loading locations...

相似试验