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临床试验/NCT07038967
NCT07038967招募中不适用

Assessment of Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年6月29日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Best Corrected Visual Acuity

研究概览

简要总结

This study aims to evaluate the progression of non-center-involving diabetic macular edema in the early postoperative period following phacoemulsification.

详细描述

Diabetic patients have been reported to have a higher prevalence of cataract and develop it at an earlier age compared with nondiabetic individuals.

According to recent population-based studies, diabetic macular edema (DME) is the most common cause of vision loss, with the incidence of non-center-involving DME (NCIDME) being higher than that of center-involving DME (CIDME). The prevalence of NCIDME in an urban south Indian population is 10.8%.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Age ≥18 years.
  • Both sexes.
  • Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).

排除标准

  • Traumatic cataract.
  • Severe Non-Proliferative/ Proliferative Diabetic Retinopathy.
  • Marked Asymmetry of retinopathy between both eyes.
  • Mature senile cataract or severe lens opacity.
  • Potentiality to have Phacotrabeculectomy surgery.
  • Complications during or after the surgery.

结局指标

主要结局

Best Corrected Visual Acuity

时间窗: 6 months post-procedure

Best Corrected Visual Acuity (BCVA) will be recorded.

次要结局

  • Intra ocular pressure(6 months post-procedure)
  • Central macular thickness (CMT)(6 months post-procedure)
  • Frequency distribution of Fluorescein leakage(6 months post-procedure)

研究者

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

Hatem Fawzy Abd Elfatah Abo saif

Lecturer of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Ain Shams University

研究点 (1)

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