跳至主要内容
临床试验/NCT04992325
NCT04992325已完成不适用

Anterior Segment- Optical Coherence Tomography as Early Biomarker in Diabetic Retinopathy

Federico II University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography

研究概览

简要总结

This study evaluates the corneal features using anterior segment - optical coherence tomography in patients affected by type 2 diabetes mellitus

详细描述

To investigate the potential role of anterior segment-optical coherence tomography (AS-OCT) in identifying the corneal changes (in particular in total corneal, epithelial and stromal thicknesses) in patients affected by type 2 diabetes mellitus, without signs of diabetic retinopathy at fundus examination.

The AS-OCT could represents a valid early biomarker in these patients.

研究设计

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

入排标准

年龄范围
50 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age older than 50 years
  • diagnosis of previous type 2 diabetes mellitus
  • absence of signs of diabetic retinopathy
  • absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
  • absence of significant lens opacities, low-quality OCT and OCT-A images

排除标准

  • age younger than 50 years
  • absence of previous diagnosis of type 2 diabetes mellitus
  • presence of signs of diabetic retinopathy
  • presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
  • presence of significant lens opacities, low-quality OCT and OCT-A images.

结局指标

主要结局

The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography

时间窗: twelve months

The parameters analyzed by anterior segment-optical coherence tomography angiography were: total corneal, epithelial and stromal thicknesses

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gilda Cennamo

Principal Investigator

Federico II University

研究点 (1)

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