The Baerveldt Versus Paul (BvP) Study: a Registry-based Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Surgical Failure
研究概览
简要总结
The Baerveldt Versus Paul (BvP) Study is a Registry-based Randomised Controlled Trial, Comparing the Baerveldt Glaucoma Implant (BGI) and the Paul Glaucoma Implant (PGI). Participants will Include patients requiring aqueous shunt surgery for control of intraocular pressure and glaucoma.
The objective of this study is to compare the long-term safety and effectiveness of placement of a BGI and PGI for patients who are undergoing aqueous shunt implant surgery. Patients who qualify for the study are randomized to receive either a BGI or PGI aqueous shunt.
详细描述
Background and Rationale:
Glaucoma is a leading cause of irreversible blindness. Reduction of intraocular pressure (IOP) is the only proven modifiable factor for slowing glaucoma progression. Glaucoma drainage devices are commonly used when glaucoma is inadequately controlled with medical or laser treatment and when other glaucoma procedures are considered likely to fail.
The 350-mm² Baerveldt Glaucoma Implant (BGI) is an established non-valved glaucoma drainage device with demonstrated efficacy and safety in previous randomised clinical trials. The Paul Glaucoma Implant (PGI) is a newer non-valved device that uses a smaller-diameter tube. The PGI has been proposed to provide improved early postoperative IOP control and potentially reduce complications such as hypotony, corneal endothelial damage and tube exposure. However, these potential advantages have not been established in a prospective randomised comparison with the BGI. Existing comparative evidence is primarily retrospective and has not demonstrated a clear difference between the devices.
The Baerveldt versus Paul Study is designed to address this uncertainty by directly comparing the long-term safety and effectiveness of the BGI and PGI in patients requiring glaucoma drainage device surgery.
Study Design:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years of age
- •Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 16 mm Hg.
- •An aqueous shunt implant as planned surgical procedure
- •A diagnosis of ocular hypertension, primary open angle glaucoma, primary angle closure glaucoma, or secondary glaucoma.
排除标准
- •Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
- •Pregnant or nursing women.
- •No light perception vision.
- •Uveitis secondary to Juvenile Idiopathic Arthritis
- •Previous cyclodestructive procedure or previous aqueous shunt device implanted in the same eye
- •Supero-temporal buckling or other external impediment to supero-temporal aqueous shunt implantation
- •Silicone oil-filled eyes or sufficient residual intraocular silicone oil to preclude supero-temporal aqueous shunt implantation
- •Vitreous present in the anterior chamber, sufficient to require a vitrectomy at the time of surgery
- •Condition with high episcleral pressure, such as Sturge-Weber or nanophthalmos
- •Acute trauma (within 3 months)
- •Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.
研究组 & 干预措施
Baerveldt Glaucoma Implant
Patients randomised to this arm will undergo insertion of a Baerveldt Glaucoma Implant.
干预措施: Baerveldt Glaucoma Implant (Device)
Paul Glaucoma Implant
Patients randomised to this arm will undergo insertion of a Paul Glaucoma Implant.
干预措施: Paul Glaucoma Implant (Device)
结局指标
主要结局
Surgical Failure
时间窗: From enrollment until the end of follow up at 5 years postoperative.
Failure in the BvP Study is defined by following criteria: * IOP \> 21 mmHg or \< 6 mmHg on 2 consecutive study visits at visits \> 3 months. * IOP not reduced by 20% (or more) below baseline on 2 consecutive study visits at visits \> 3 months. * Additional glaucoma surgery * Loss of light perception vision * Removal of implant for any reason
次要结局
- Visual acuity(From enrollment until the end of follow up at 5 years postoperative.)
- Intraocular Pressure(From enrollment until the end of follow up at 5 years postoperative.)
- Number of glaucoma medications(From enrollment until the end of follow up at 5 years postoperative.)
- Visual field outcomes(From enrollment until the end of follow up at 5 years postoperative.)
- Safety Outcomes(From enrollment until the end of follow up at 5 years postoperative.)