Efficacy and Safety of the XEN63: a Prospective Observational Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 96
- 试验地点
- 19
- 主要终点
- Number of hypotensive eye drops
研究概览
简要总结
The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation.
详细描述
The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation. Every patients will be followed for 24 months.
Secondary aims of the study are:
- Evaluating the hypotensive efficacy of the XEN63 12 months after implantation.
- Assessing the safety of the XEN63 device after 12 and 24 months after implantation.
- Comparing the hypotensive efficacy of the XEN63 in glaucomatous patients undergoing the solo procedure and in those undergoing the combo procedure
- Evaluating the quality of life of patients undergoing XEN63 implantation 12 and 24 months after implantation.
- Evaluating the association between factors related to the patient, the surgical technique or post-operative management and the hypotensive efficacy of the device during follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines.
- •Need for XEN63 implantation for IOP not controlled by medical therapy, progression of disease or intolerance to topical therapy, in association or not with cataract surgery.
- •Informed consent freely given and obtained before the start of the study.
- •The participant has the ability to understand and the willingness to follow the study instructions and is likely to complete all required visits and procedures.
排除标准
- •Closed-angle glaucoma
- •Previous trabeculectomy or valve or tube placement.
- •Presence of conjunctival scarring, previous conjunctival surgery or other conjunctival pathologies (e.g. pterygium) in the target quadrant.
- •Signs of active inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis)
- •Active iris neovascularization or presence of iris new vessels within 6 months of the date of surgery
- •Anterior chamber lenses
- •Presence of intraocular silicone oil
- •Vitreous in anterior chamber
- •Altered episcleral venous drainage (e.g. Sturge Webwer syndrome, nanophthalmos)
- •Known or suspected allergy or sensitization to medications required for the surgical procedure or some component of the device (e.g. glutaraldehyde or porcine derivatives)
- •History of predisposition to the formation of keloids.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Glaucoma
Diagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines.
结局指标
主要结局
Number of hypotensive eye drops
时间窗: up to 2 years
Number of hypotensive eye drops
IOP
时间窗: up to 2 years
IOP values before and after 24 months of XEN63 implant.
次要结局
- Complications(up to 2 years)
- Post operative management(up to 2 years)
- IOP(From enrollment to 12 months after surgery)
- Number of hypotensive eye drops(From enrollment to 12 months after surgery)
- Quality of life after XEN63 implant(up to 2 years)
- Surgical tecnique(during the intervention/procedure/surgery)
- Post operative needling(up to 2 years)
- Surgical revision(up to 2 years)
- Glaucoma Symptom Scale(up to 2 years)
- Surgical technique(during the intervention/procedure/surgery)
研究者
Mario Stirpe
Prof
Fondazione G.B. Bietti, IRCCS