NCT06289491招募中不适用
Randomized Trial of Hydrus Microstent Versus Goniotomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Intraocular pressure-lowering medications
研究概览
简要总结
The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are:
- How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare?
- How do the safety profiles of these three microinvasive glaucoma surgeries compare?
Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visually significant cataract planned for surgery
- •Mild to moderate open-angle glaucoma, including pigmentary glaucoma and pseudoexfoliation glaucoma
- •Mild stage glaucoma includes glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB, with no points in the central 5 degrees <15 dB
- •Moderate stage glaucoma includes: 1) glaucomatous optic neuropathy and visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5 degree points <15 dB or 2) mean deviation -12.0 dB or better with 1 central 5 degree point <15 dB
- •Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery
- •Willing and able to understand and provide informed consent
- •Willing and able to attend postoperative examinations per protocol schedule
排除标准
- •Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation
- •Selective laser trabeculoplasty within 90 days of study enrollment
- •Iridotrabecular contact for 180 degrees or greater
- •Peripheral anterior synechiae in nasal or inferior angle
- •Best corrected visual acuity worse than 20/200
- •Phacodonesis on pre-operative examination
- •Vitreous in anterior chamber on pre-operative examination
- •Nanophthalmos
- •Anti-platelet and anticoagulant medications other than aspirin 81mg daily
- •Active treatment for another ophthalmic condition in either eye (e.g., anti-VEGF injections, steroids for corneal transplant)
- •Abnormality in study eye that could affect tonometry
- •Glaucoma diagnosis other than the above
- •Normal tension glaucoma
- •Conditions that can cause elevated episcleral venous pressure (e.g., Sturge-Weber syndrome, Graves disease, retrobulbar tumor)
- •History of uveitis in either eye
- •Inability to complete gonioscopy examination
- •Use of oral steroids within 90 days or anticipated use of oral steroids
- •Oral medications that can affect IOP, including oral carbonic anhydrase inhibitors such as acetazolamide and methazolamide
- •History of steroid-associated IOP elevation
- •Medically unfit for attending planned study visits
- •Involvement in another interventional research study
研究组 & 干预措施
Hydrus Microstent
Experimental
干预措施: Hydrus Microstent (Procedure)
Incisional goniotomy
Experimental
干预措施: Incisional goniotomy (Procedure)
Excisional goniotomy
Experimental
干预措施: Excisional goniotomy (Procedure)
结局指标
主要结局
Intraocular pressure-lowering medications
时间窗: 3 years
Intraocular pressure
时间窗: 3 years
次要结局
- Surgical complications(3 years)
研究者
Michael M. Lin, MD
Assistant Professor of Ophthalmology
Massachusetts Eye and Ear Infirmary
研究点 (1)
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