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临床试验/NCT04703231
NCT04703231已完成不适用

Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause

Batman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9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
60
试验地点
1
主要终点
Macular thickness measurement

研究概览

简要总结

It is aimed to compare the ocular findings in patients with natural and surgical menopause.

详细描述

To compare the parameters such as fundus examination, macular thickness, visual acuity and lens opacities among female patients diagnosed with menopause between the ages of 40-65.The criteria for exclusion from the study are the presence of a history of illness, drug use, smoking and alcohol use.Inclusion criteria were female patients who were in menopause and who did not use any medications. For surgical menopause, the uterus and ovaries were surgically removed at least 3 months ago.

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
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Newly diagnosed menopause (Natural or Surgical Menopause( At least 3 months after surgery),
  • No history of illness(Diabetes,Heart disease,Kidney disease etc.)
  • Not Smoking
  • Did not use alcohol
  • Have not use any medication
  • Age between 45-65 years
  • BMI between 20-25 kg/m

排除标准

  • Smoking or Alchohol consumption
  • Age before 45 and after 65 years
  • Have chronic disease
  • Using any medication
  • Have not diagnosed Menopause
  • BMI greater than 30 kg/m

结局指标

主要结局

Macular thickness measurement

时间窗: 3 months after menopause

Macular thickness(micron) in both eyes will be measured by optical coherence tomography,

Detecting lens opacities

时间窗: 3 months after menopause

Lens opacities (Grade 1,2,3,4) will be measured by indirect biomicroscopy,

Intraocular pressure measurement

时间窗: 3 months after menopause

Intraocular pressures( mm Hg) will be measured and recorded with the applanation tonometry device.

Comparison of all detected data

时间窗: 3 months after menopause

All numerical data will be analyzed and compared with relevant statistical tests and the p value will be accepted as less than 0.05 to be considered a statistically significant difference.

次要结局

未报告次要终点

研究者

发起方
Batman Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Erhan Okuyan,M.D

Principle investigator

Batman Training and Research Hospital

研究点 (1)

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