Evaluation of the Effectiveness of the New Surgical Method OMNI in the Treatment of Adult Patients With Open-angle Glaucoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Number of Participants wih Postoperative complications
研究概览
简要总结
This single-center, prospective study will assess safety and effectiveness of 360 degree viscodilation followed by up to 360 degree trabeculotomy used in patients with early or moderate open-angle glaucoma in a real-world setting either as a standalone procedure in pseudophakic patients (or phakic) or combined with phacoemulsification cataract procedures.
Medication usage, IOP and secondary surgical procedures necessary for IOP control will be analyzed during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •diagnosed with open-angle glaucoma including pigmentary and pseudoexfoliative glaucoma
- •0-3 topical ocular hypotensive medications at preoperative baseline. Fixed combinations counted as number of components
- •Open angles (Shaffer grade ≥3)
- •early or moderate glaucoma (based on visual field)
- •Subjects with a combined procedure should have had uncomplicated cataract surgery (i.e. intact and centered capsulorrhexis, intact posterior capsular bag, no evidence of zonular dehiscence or rupture, well centered IOL)
排除标准
- •Any of the following prior treatments for glaucoma:
- •Suprachoroidal stent
- •Laser trabeculoplasty ≤6 months prior to OMNI procedure
- •Trabecular bypass implanted ≤6 months prior to OMNI procedure
- •Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma draining device/valve
- •Prior canaloplasty, goniotomy, or trabeculotomy
- •Forms of glaucoma other than OAG including: acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- •Under treatment with oral carbonic anhydrase inhibitor at the preoperative visit
- •Clinically significant ocular pathology, other than age-related cataract and glaucoma. (e.g. wet AMD, uveitis, corneal edema, proliferative diabetic retinopathy, optic neuritis in medical history)
结局指标
主要结局
Number of Participants wih Postoperative complications
时间窗: 1 year
Proportion of eyes with a 20% reduction from baseline in IOP at 12 months on the same number, or fewer, ocular hypotensive medications as at the pre-operative baseline
时间窗: 1 year
次要结局
未报告次要终点
研究者
Iwona Grabska- Liberek
Professor
Centre of Postgraduate Medical Education