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临床试验/NCT03590587
NCT03590587Unknown不适用

Rapid Structural and Functional Improvements in Following 0.19 mg Fluocinolone Acetonide (FAc) Implant in Diabetic Macular Edema Patients With Poor Visual Acuity: 12-month Audit Results From United Arab Emirates

Benha University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
BCVA

研究概览

简要总结

The Health Authority - Abu Dhabi (HAAD) approved the reimbursement of the slow release FAc implant (ILUVIEN) and it is now available for the treatment of diabetic macular edema (DME) in persons who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. We performed a retrospective 12-month audit to assess the efficacy and safety of the FAc implant in our clinical practice.

详细描述

Twenty patients with pseudophakic lenses, treated with ILUVIEN, were investigated to evaluate functional and anatomical characteristics and outcomes (visual acuity [VA; ETDRS letters score], central macular thickness [CMT] and intraocular pressure [IOP]) at baseline, weeks 2-4 and months 3, 6 and 12 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Pseudophakic

排除标准

  • Other causes of macular edema.
  • Know case of gaucoma

研究组 & 干预措施

1

patients treated with 0.19 mg fluocinolone acetonide (FAc) implant for 12 months

干预措施: 0.19 mg fluocinolone acetonide (FAc) implant (Device)

结局指标

主要结局

BCVA

时间窗: 12 months

best corrected visual acuity

次要结局

  • CMT(12 months)
  • IOP(12 months)

研究者

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

Ahmed Elbarky

assistant professor of ophthalmologyu

Benha University

研究点 (1)

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