跳至主要内容
临床试验/NCT04783909
NCT04783909已完成不适用

Refractive Outcomes of Phacoemulsification Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Medical University of Lublin0 个研究点目标入组 80 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
To compare refractive outcomes in PEX and control eyes.

研究概览

简要总结

To evaluate the refractive outcomes of cataract surgery in PEX syndrome and determine which of the commonly used IOL formulas (SRK/T, Barrett Universal II and Hill-RBF) is the best in predicting postoperative refractive outcomes in PEX.

详细描述

The primary outcome measure was to compare refractive outcomes (MAE, MedAE, percentage of eyes within certain range of prediction error) in PEX and control eyes. The secondary outcome measure was to determine whether any of IOL power prediction formulas (SRK/T, Barrett Universal II and Hill-RBF) is more precise for these challenging eyes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • senile cataract with/without PEX

排除标准

  • corneal pathology
  • glaucoma,
  • corneal astigmatism greater than 2.0 diopters (D),
  • previous eye surgery or subjects with decreased vision due to other reasons than cataract (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases),
  • intraoperative complications,
  • postoperative corrected distance visual acuity (CDVA) worse than 20/40,
  • axial length below 21 mm and above 25 mm,
  • dense cataracts or poor fixation requiring ultrasound biometry
  • eyes with manifest iridophacodonesis and those in which a capsular tension ring was inserted

结局指标

主要结局

To compare refractive outcomes in PEX and control eyes.

时间窗: 3 months

To measure MAE, MedAE, percentage of eyes within certain range of prediction error after cataract surgery

次要结局

  • To determine whether any of IOL power prediction formulas is more precise for these challenging eyes.(3 months)

研究者

申办方类型
Other
责任方
Sponsor

相似试验