NCT06213805已完成不适用
Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery
Hôpital Privé de la Baie6 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年1月15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
- 23
- 试验地点
- 6
- 主要终点
- Measurement of intraocular pressure by tonometry
研究概览
简要总结
The main objective is to evaluate the effectiveness of MIMS in patients with an indication for glaucoma surgery, compared to traditional surgery. The secondary objective is to assess safety. The investigating ophthalmologist will follow the patients and collect clinical data in order to identify the benefits and complications of MIMS. Patients are expected to experience fewer complications compared to traditional glaucoma surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old who agree to participate in the study having signed informed consent
- •Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma with indication for glaucoma surgery (defined as uncontrolled intraocular pressure or worsening of visual fields, despite maximum tolerated medical therapy) and open iridocorneal angle ( trabecular meshwork visible on gonioscopy, Shaffer classification grade 3-4) and healthy and mobile conjunctiva (without scars or adhesions).
- •Chronic angle closure glaucoma with indication for combined glaucoma and cataract surgery
排除标准
- •Presence of other ophthalmological pathologies (except cataract)
- •History of intraocular surgery (unless cataract surgery), history of trauma, or conjunctival scarring in the quadrant planned for surgery
- •Visual acuity lower than "counts fingers" ", closure of the iridocorneal angle (and angle-closure glaucoma unless associated cataract surgery), neovascular glaucoma or neovascularization of the iris, pachymetry < 490 μm or > 620 μm.
- •Presence of severe systemic pathologies, pregnant or breastfeeding woman
结局指标
主要结局
Measurement of intraocular pressure by tonometry
时间窗: day 0, day 7, day 14, day 30, month 6, month 9 and month 12 after surgery
Measure in millimeters of mercury (mmHg)
次要结局
- Optical Coherence Tomography(month 3, month 12)
- visual quality of life VFQ-25,(month 1, month 3, month 12 after surgery)
- Visual field test(month 3, month 12)
研究者
研究点 (6)
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