跳至主要内容
临床试验/NCT03340389
NCT03340389Unknown不适用

Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Dysfunctional lens index

研究概览

简要总结

To study the correlations among the dysfunctional lens index (DLI), Lens Opacities Classification System III (LOCS III) nuclear opalescence grading score, preoperative corrected distance visual acuity (CDVA), the objective scatter index (OSI) and Scheimpflug based average lens density in age-related cataracts. To investigate the potential of the DLI as a novel surgery decision maker via the Operating Characteristic (ROC) curve analysis.

详细描述

Each patient received a comprehensive eye examination, including corrected distance visual acuity (CDVA) preoperatively and the day after surgery, subjective refraction, slit-lamp evaluation, noncontact tonometry (TX-F; Cannon, Tokyo, Japan), and dilated fundus examination. According to the surgery decision made by the three surgeons based on the slit lamp biomicroscopy and CDVA, patients were divided into two groups: Surgical and Non-Surgical. The results of the DLI, OSI and average lens density (ALD) were masked to the surgeons. The DLI, OSI, average lens density, LOCS III nuclear opalescence grading, and preoperative CDVA were obtained. Correlations among these parameters were analyzed. ROC curves were used to analyze DLI values to determine a value to separate between surgical and non-surgical cataracts.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with age-related cataracts

排除标准

  • any corneal opacity, corneal dystrophies, retinal anomalies, a history of ocular surgery or laser treatment, a LOCS III grade of cortical opacity ≥ 3.0 or posterior subcapsular cataract ≥ 2.0.

研究组 & 干预措施

cataract surgery

Experimental

cataract extraction and intraocular implantation

干预措施: a ray-tracing aberrometry (Procedure)

结局指标

主要结局

Dysfunctional lens index

时间窗: 6 months

The DLI is an objective lens performance metric derived from internal higher order aberrations (HOAs), pupil size, and contrast sensitivity data

次要结局

未报告次要终点

研究者

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

yin ying zhao

Director

Wenzhou Medical University

研究点 (1)

Loading locations...

相似试验