Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma Compared to Classic Glaucoma Surgeries (Trabeculectomy and Sclerectomy) as Well as Other Minilally Invasive Glaucoma Surgery (MIGS)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Unqualified success
研究概览
简要总结
To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •diagnosis of primary open angle glaucoma
- •trabecular meshwork visible in gonioscopy
- •medicated IOP of ≥ 15 mmHg and ≤ 35 mmHg
- •taking 1 to 5 IOP-lowering medications
- •area of healthy, free and mobile conjunctiva in the target quadrant (superior-nasal)
- •signed inform consent
排除标准
- •angle closure glaucoma
- •secondary open angle glaucoma
- •previous glaucoma shunt/valve in the target quadrant
- •presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
- •active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
- •active iris neovascularization or neovascularization of the iris within 6 months of the surgical date
- •anterior chamber intraocular lens
- •presence of intraocular silicone oil
- •vitreous present in the anterior chamber
- •impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure)
- •known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde)
- •history of dermatologic keloid formation
- •previous photorefractive keratectomy
研究组 & 干预措施
stand-alone procedure of XEN implantation in phakic eyes
干预措施: 5-fluorouracil (Drug)
stand-alone procedure of XEN implantation in phakic eyes
干预措施: Transconjunctival needling (Procedure)
stand-alone procedure of XEN implantation in phakic eyes
干预措施: Transconjunctival revision (Procedure)
stand-alone procedure of XEN implantation in pseudophakic eyes
干预措施: 5-fluorouracil (Drug)
stand-alone procedure of XEN implantation in pseudophakic eyes
干预措施: Transconjunctival needling (Procedure)
stand-alone procedure of XEN implantation in pseudophakic eyes
干预措施: Transconjunctival revision (Procedure)
XEN implantation combined with cataract extraction
干预措施: 5-fluorouracil (Drug)
XEN implantation combined with cataract extraction
干预措施: Transconjunctival needling (Procedure)
XEN implantation combined with cataract extraction
干预措施: Transconjunctival revision (Procedure)
结局指标
主要结局
Unqualified success
时间窗: 5 years
Unqualified success of glaucoma treatment, defined as a postoperative IOP \<18 mmHg and \>20% reduction compared with the baseline value, achieved without use of any antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.
次要结局
- Qualified success score B(5 years)
- Qualified success score C(5 years)
- Qualified success score A(5 years)
研究者
Joanna Przeździecka-Dołyk
Investigator
Wroclaw Medical University