Pressure Reduction and Medication Use Following Different Minimally Invasive Glaucoma Surgery Procedures, Prospective Randomized Clinical Trial of Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
The primary objective of this research is to compare the efficacy of trabecular minimally invasive glaucoma surgery (MIGS) devices (iStent vs iStent Inject vs Hydrus) for intra ocular pressure (IOP) and anti-glaucoma medication reduction in open angle glaucoma.
详细描述
Study Design Prospective Randomized Clinical Trial (Parallel Group Study)
Patients who fit inclusion criteria will be randomly assigned to one of the 3 parallel groups (one of the study surgical interventions combined with phacoemulsification) in the following order:
- 1st Generation iStent, Trabecular Micro-Bypass Device (Glaukos Inc, San Clemente, CA).
- 2nd Generation iStent, Trabecular Micro-Bypass Device (Glaukos Inc, San Clemente, CA).
- Hydrus Microstent (Ivantis Inc, Irvine, CA). Blocked randomization will be used in 1:1:1 ratio to provide balanced study groups. Allocation will be performed using a random number table.
Preoperative Evaluation of : Visual acuity, Slit lamp examination, IOP, Gonioscopy, Fundus Examination, Central corneal thickness (CCT), Endothelial Cell Count (ECC), Visual field, Retinal Nerve Fiber layer (RNFL) thickness by Optical Coherence Tomography (OCT) and Number and type of preoperative antiglaucoma medications.
Patients will be followed postoperatively at Day 1, Week 1, Months 1, 3, 6 and 12.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female aged 40 years or more.
- •Patients able and willing to provide informed consent.
- •Patients having Visually Significant Age Related Cataract with Mild to Moderate Open Angle Glaucoma (OAG) on topical anti-glaucoma medication with or without previous Selective Laser Trabeculoplasty (SLT) ), including:
- •Primary open angle glaucoma (POAG).
- •Pigmentary glaucoma.
- •Pseudoexfoliative glaucoma.
- •Patients should be candidate for safe mediaction wash out in the opinion of the investigator.
- •The diagnosis of glaucoma is confirmd by optic nerve examination and the characteristic visual field defects on automated perimetry according to the American Academy of Ophthalmology (AAO) Definition and Criteria.
- •The severity of glaucoma is classified using the Hodapp Parrish Anderson Visual Field Criteria depending on the Mean Deviation (MD):
- •Mild: MD no worse than -6 dB.
- •Moderate: MD worse than -6 but no worse than -12 dB.
- •Severe: MD worse than -12 dB.
排除标准
- •Glaucoma types rather than open angle glaucoma types mentioned in the inclusion criteria (Primary, Pigmentary and Pseudoexfoliation Glaucomas).
- •Any prior glaucoma, corneal or vitreoretinal surgery.
- •Evidence of concomitant retinal, optic nerve, or neurological diseases affecting the visual field.
- •Abnormal angle anatomy.
- •Prior Argon Laser Trabeculoplasty (ALT), Laser Iridotomy or Iridoplasty.
- •Any systemic condition or medications affectiong IOP.
- •Corneal opacity, corneal dystrophy or central corneal thickness (CCT) less than 480 or more than 620 microns.
- •Exclusion from medications wash out according to the opinion of the investigator Or if any of the following is observed at any time point of the study:
- •Visual Field: Mean deviation worse than -12 dB.
- •Intraocular pressure: a treated IOP of greater than 24 mmHg.
- •Medications: using more than three medications.
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: 1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12
Reduction of IOP after eye surgery measured in millimeters of mercury (mmHg)
次要结局
- Visual Acuity(1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12)
- Endothelial Cell Count(1 hour examination at Baseline, Months 3, 6 and 12)
- Central Corneal Thickness (CCT)(1 hour examination at Baseline, Months 3, 6 and 12)
研究者
Daniel Lee, MD
Principle Investigator
Wills Eye