Comparison of the Safety and Efficacy of PreserFlo MicroShunt and XEN Stent Alone Versus With Amniotic Membrane in Glaucoma Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 156
- 主要终点
- Rate of adverse events
研究概览
简要总结
Glaucoma is one of the leading causes of permanent blindness in the world. It happens when the optic nerve-the connection between the eye and the brain-is damaged. As this damage gets worse, vision is slowly lost.
Glaucoma treatments often begin with eye drops to lower eye pressure. If drops are not enough, surgery may be needed. The type of surgery depends on how advanced the glaucoma is and how much vision has already been lost.
Some glaucoma surgeries, including trabeculectomy, PreserFlo MicroShunt, and XEN Stent, create a new pathway for fluid to drain out of the eye. This helps lower pressure inside the eye.
However, after surgery, the body's natural healing process can sometimes cause inflammation and scarring, which may block the new drainage pathway. If this happens, eye pressure can rise again, and the surgery may not work as well as hoped.
This study is testing whether covering the PreserFlo or XEN devices with amniotic membrane (a safe tissue already used in other eye surgeries) can reduce scarring, improve healing, and lead to better long-term results. Amniotic membrane has already been used safely in many types of eye surgeries. It has been shown to improve healing and reduce scarring in some glaucoma surgeries. But it has not yet been studied in PreserFlo MicroShunt or XEN Stent procedures. The goal is to see if adding amniotic membrane makes the surgery safer and more effective for people with glaucoma.
详细描述
Glaucoma is the leading cause of permanent blindness worldwide. Glaucoma is damage to the optic nerve, which sends information from the eye to the brain. This damage causes vision to weaken. Treatment for glaucoma includes the use of medication drops and, ultimately, surgery. The type of surgery is decided by determining the severity and progress of an individual's vision loss.
Certain glaucoma surgeries (including PreserFlo microshunts, and Xen stents) involve creation of an alternative passage for the liquid inside of the eye to be drained. Glaucoma surgery is complex and excessive inflammation and scarring can increase pressure inside the eye and lead to surgical failure. We hope that covering PreserFlo microshunts and Xen stents with amniotic membrane will result in reduced scarring and better pressure outcomes after these surgeries.
Previous research has shown that amniotic membrane is safe for the eye and has improved the outcomes of other similar glaucoma surgeries. However, there are no studies that have investigated whether amniotic membrane is a safe and effective in PreserFlo microshunts, and Xen stents surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age 18 years and older
- •Patients selected for PreserFlo microshunt surgery and XEN stent alone or in combination with cataract surgery.
- •Ability to comprehend the study procedures
排除标准
- •Unwilling or unable to give consent
- •Unable to come for scheduled post-operative visits
- •Pregnant or nursing women
- •Previous cyclodestructive procedures, scleral buckling procedures, or presence of silicone oil
- •Conjunctival scarring precluding a glaucoma surgery superiorly
- •Active iris neovascularization or active proliferative retinopathy
- •Vitreous in the anterior chamber for which a vitrectomy is anticipated.
- •Previous trabeculectomy, tube-shunt implantation, or surgeries that shunt aqueous outflow into the subconjunctival space
结局指标
主要结局
Rate of adverse events
时间窗: Surgery (Day 0) to 12 months
Proportion of study eyes with ≥1 of: persistent uveitis, blebitis, endophthalmitis, clinically significant hypotony, stent erosion, bleb dysesthesia, or loss of best-corrected visual acuity. Each AE recorded as yes/no; between-group comparisons via logistic regression (adjusting for device type and baseline IOP).
Relative Reduction in Intraocular Pressure (IOP) at 3, 6, and 12 Months
时间窗: Baseline to 3, 6, and 12 months
Percent change from baseline IOP at each post-operative visit. Calculated per study eye as: \[(Baseline IOP - Visit IOP) / Baseline IOP\] × 100. Primary efficacy analysis uses a linear mixed-effects model (repeated measures) with fixed effects for treatment group (amniotic membrane vs no membrane), visit (3/6/12 months), treatment × visit interaction, device type (PreserFlo vs XEN), and baseline IOP; participant (study eye) included as a random effect. Estimates will report least-squares mean differences between groups in percent reduction at each visit and an overall treatment effect across visits, with 95% confidence intervals and p-values
次要结局
- Number of re-operations(Through 12 months post-op)
- Number of Glaucoma Medications(3, 6 and 12 month post-op)
- Time to Surgical Failure(From surgery to 12 months post-op (failures assessed after postoperative Month 3))
研究者
Lesya Shuba
Principal Investigator
Nova Scotia Health Authority