Evaluation of Microinvasive Glaucoma Surgery: MINIject® Versus Hydrus® Microstent in Combination With Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Intraocular Pressure After Surgery
研究概览
简要总结
The study aims to investigate postoperative outcomes after two different MIGS implants (MINIject or Hydrus) in combination with cataract surgery for patients with glaucoma.
详细描述
The study aims to investigate postoperative outcomes in terms of intraocular pressure as well as safety measures after two different MIGS implants (MINIject® or Hydrus®) in conjunction with cataract surgery (CS) for patients with chronic glaucoma. The patients will be followed up for 5 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination and ocular imaging with OCT (Optical Coherence Tomography). Assessment of life quality as well as adverse events will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients with glaucoma in which surgery is indicated to reach target intraocular pressure as well as lens opacities where CS is indicated
- •Clinically eligible for both surgeries
- •Subjects not anticipated to require any further surgery in the next 12 months
- •Patients' age > 18 years
排除标准
- •Patients who do not want to make follow-ups at the department
- •Angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrome, Axenfeld-Rieger syndrome
- •Prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation
- •Allergy to any drugs or substances required for the protocol
- •Pregnant women
结局指标
主要结局
Intraocular Pressure After Surgery
时间窗: Baseline visit to 1 year
Mean IOP in mmHg one year after glaucoma surgery
次要结局
- Intraocular Pressure at Other Follow-Up Time Points(Baseline visit to 5 years)
- Anti-Hypertensive Medications Required(Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5)
- Best Corrected Visual Acuity(Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5)
- Complete Success(Baseline visit and visit at month 3/6 and year 1/2/3/4/5)
- Qualified Success(Baseline visit and visit at month 3/6 and year 1/2/3/4/5)
- Endothelial Cell Density(Baseline visit and visit at year 1/2/3/4/5)
- Assessment of Life Quality - Glaucoma Quality of Life-15 Questionnaire(Baseline visit and visit at month 6 and year 1/2/3/4/5)
- Assessment of Life Quality - Ocular Surface Disease Index(Baseline visit and visit at month 6 and year 1/2/3/4/5)
- Rate of Additional Ocular Surgery Post-Implantation(5 years)
- Rate of Complications or Incidents(5 years)
- Data From Optical Biometry - Axial Length(Baseline visit and year 1 visit)
- Data From Optical Biometry - Anterior Chamber Depth(Baseline visit and year 1 visit)
- Data From Optical Biometry - Corneal Surface Parameters(Baseline visit and year 1 visit)
- Standard Automated Perimetry(Baseline visit and visit at month 6 and year 1/2/3/4/5)
- Optical Coherence Tomography - RNFL Thickness(Baseline visit and visit at month 1/3/6 and year 1/2/3/4/5)