Ozurdex as an Treatment Option for Macula Edema Due to Irvine Gass Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.
详细描述
20 to 25 patients suffering from Irvine Gass Syndrom should be monitored for at least six months, controlled monthly. In all cases best corrected visual acuity, Spectralis-OCT (volume thickness scan), fundus photography (Optomap), intraocular pressure, slitlamp assessment and indirect ophthalmoscopy should be performed on every visit. Fluorescein angiography should be performed at baseline and after 3 and 6 months.
Inclusion criteria:
Patients older than 18 years who develop macula edema secondary to cataract surgery.
- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".
Exclusion criteria:
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years who develop macula edema secondary to cataract surgery
排除标准
- •Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.
研究组 & 干预措施
Irvine Gass Syndrome
Patients older than 18 years who develop macula edema secondary to cataract surgery.
Group may receive intravitreal Ozurdex medication in case of persistent macular edema.
干预措施: Ozurdex (Drug)
结局指标
主要结局
Visual acuity
时间窗: 12 months
Best corrected visual acuity and visual acuity gain after 6 and 12 months.
次要结局
- Retinal Thickness(12 months)
- Intraocular pressure(12 months)
研究者
Wolfgang Mayer
Dr.
Ludwig-Maximilians - University of Munich