Primary Tube Versus Trabeculectomy Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 16
- 主要终点
- Number of Participants With Surgical Failure
研究概览
简要总结
The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular 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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years
- •Glaucoma that is inadequately controlled on tolerated medical therapy with Intraocular Pressure (IOP) greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
- •No previous incisional ocular surgery
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
- •Active iris neovascularization or active proliferative retinopathy
- •Iridocorneal endothelial syndrome
- •Epithelial or fibrous ingrowth
- •Chronic or recurrent uveitis
- •Steroid-induced glaucoma
- •Severe posterior blepharitis
- •Unwilling to discontinue contact lens use after surgery
- •Previous cyclodestructive procedure
- •Conjunctival scarring from prior ocular trauma or cicatrizing disease precluding a superior trabeculectomy
- •Functionally significant cataract
- •Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery
研究组 & 干预措施
Tube shunt surgery group
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
干预措施: Tube shunt surgery (Procedure)
Trabeculectomy with Mitomycin C
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
干预措施: Trabeculectomy (Procedure)
Trabeculectomy with Mitomycin C
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
干预措施: Mitomycin C (Drug)
结局指标
主要结局
Number of Participants With Surgical Failure
时间窗: Up to 5 years
Surgical failure is defined as: 1. Inadequate Intraocular Pressure (IOP) Reduction (IOP \> 21 mmHg or reduced \< 20% below baseline on 2 consecutive follow-up visits after 3 months) 2. Reoperation for glaucoma 3. Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months) 4. Loss of light perception vision
次要结局
- Visual Acuity as Measured Using EDTRS Chart(At baseline, At 5 years)
- Visual Field(Up to 5 years)
- Reoperation for Glaucoma(Up to 5 years)
- Number of Participants With Reported Postoperative Complications(Up to 5 years)
- Intraocular Pressure(At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years)
- Visual Acuity Using a Snellen Chart(At Baseline, At 5 years)
- Number of Glaucoma Medications(At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years)