A Prospective, Unmasked, Single-Site Investigation of the iStent Inject® Devices Implanted in Combination With Cataract Surgery in Patients With Open-Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Performance Outcome: IOP reduction
研究概览
简要总结
The aim of this study is to evaluate the safety and intraocular pressure (IOP) lowering effect of two iStent inject devices in combination with cataract surgery in patients with mild-to-moderate open-angle glaucoma.
详细描述
Patients suffering from open-angle glaucoma who are planning to undergo cataract surgery and are matching the inclusion criteria will be offered to join the study until the desired sample size (50) is reached. Combined cataract-iStent surgery will be performed as per the devices' manufacturers' instructions. Two iStent inject devices will be micro-invasively implanted in the trabecular meshwork of the eye during planned cataract surgery. Six post-operative follow-ups will be carried out over a duration of 12 months, during which various measurements will be made. Performance Outcomes will analyse the proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 6 and 12 months. Quality of life outcome will look at the improvement in perceived quality of life as expressed in the NEI VFQ-25 questionnaires from baseline to 3 and 12 months. The rate of adverse events will be recorded.
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
- •Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma
- •Mild to moderate glaucoma (defined as C/D ratio ≤ 0.8)
- •Phakic eye requiring cataract surgery
- •Preoperative IOP up to 30 mmHg (medicated or not)
- •Patients with side-effects to, or complications from, medications
- •Patients who would benefit from a reduction of IOP and/or reduction of medication
- •Normal angle anatomy as determined by gonioscopy;
- •Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair proper placement of iStent inject device
- •Able and willing to attend scheduled follow-up exams for 12 months postoperatively
- •Able and willing to provide written informed consent on the approved Informed Consent Form
排除标准
- •Inclusion of the fellow eye in this study (only one eye per subject)
- •Aphakic patients or pseudophakic patients
- •Prior stent implantations in the study eye
- •Eyes with primary angle closure glaucoma, or any secondary angle closure glaucoma
- •Traumatic or uveitic glaucoma; or any glaucoma associated with vascular disorders
- •Patients with any type of condition that may cause elevated episcleral venous pressure
- •Functionally significant visual field loss, including severe nerve fiber bundle defects such as Bjerrum scotoma
- •Prior glaucoma treatment (laser or surgery)
- •Any active corneal inflammation, edema, or opacity severe-enough to impair gonioscopy / fundus examination
- •Any pathology for which, in the investigator's judgment, the following would be either at risk or contraindicated:
- •stent implantation,
- •compliance to elements of the study protocol.
结局指标
主要结局
Performance Outcome: IOP reduction
时间窗: 12 months
Proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 12 months.
次要结局
- Safety Outcome: Adverse events(12 months)
- Quality of life: NEI VFQ-25 score(12 months)
研究者
Dr. Kaweh Mansouri
Sponsor-Investigator, Primary investigator
Swiss Vision Network