The Asia Primary Tube Versus Trab (TVT) Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Failure
研究概览
简要总结
Comparison of Ahmed Glaucoma Implant (AGI) against trabeculectomy with mitomycin C in patients with uncontrolled open angle glaucoma
详细描述
The objective of the Asia Primary Tube versus Trab (TVT) study is to compare the efficacy and safety of placement of an Ahmed Glaucoma Implant (AGI) (New World Medical Inc., Rancho Cucamonga, CA, USA) against trabeculectomy with mitomycin C in patients with uncontrolled glaucoma, who may or may not have had previous clear corneal cataract surgery with intraocular lens implantation, over 5 years. Outcome discrimination between the two treatment groups will be made using following parameters:
- Intraocular pressure
- Need for supplemental medical therapy
- Incidence of short and long term surgical complications and need for re-operation.
- Visual function (Visual acuity and Visual field)
Hypothesis
Glaucoma drainage implants have better surgical outcomes in terms of IOP lowering efficacy compared to trabeculectomy with mitomycin-C over 5 years in Asian patients with medically uncontrolled glaucoma.
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
- Double (Participant, Investigator)
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
- •Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma.
- •IOP > 18 mm Hg on 2 or more medications on at least 2 visits
- •Informed consent given and consent form signed.
排除标准
- •Unwilling or unable to give consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits.
- •Pregnant or nursing women
- •No light perception vision
- •Previous incisional intraocular surgery, other than uncomplicated clear corneal cataract surgery
- •Previous ocular laser in study eye (keratorefractive surgery and cyclodestructive procedure), except for laser trabeculoplasty procedures (Argon Laser and Selective Laser Trabeculoplasty)
- •Iris neovascularisation or proliferative retinopathy
- •Primary angle closure or primary angle closure glaucoma
- •Iridocorneal endothelial syndrome or anterior segment dysgenesis
- •Epithelial or fibrous downgrowth
- •Chronic or recurrent uveitis
- •Severe posterior blepharitis
- •Unwilling to discontinue contact lens use after surgery
- •Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery or neovascular disease
- •Conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease precluding a superior trabeculectomy
- •Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery
- •Advanced glaucoma with MD <-20dB
研究组 & 干预措施
Tube implant
Ahmed Glaucoma Implant (AGI) surgery
干预措施: Ahmed Glaucoma Implant (Device)
Trabeculectomy
Trabeculectomy with mitomycin C surgery
干预措施: Trabeculectomy with Mitomycin C (Procedure)
结局指标
主要结局
Failure
时间窗: 6 months
Failure defined by ANY of the following criteria: * IOP ≥ 18 mm Hg on two consecutive follow-up visits after 6 months * IOP not reduced to 20% below baseline on two consecutive visits after 6 months * IOP ≤ 5 mm Hg with visually significant hypotony maculopathy on two consecutive visits after 3 months * Additional glaucoma surgery, excluding laser suture lysis, removal of releasable trabeculectomy or conjunctival sutures, needling of the bleb or tube plate with or without 5FU, subconjunctival 5FU injections and anterior chamber reformation. * Loss of light perception vision
次要结局
- Best Corrected Visual Acuity (BCVA)(60 months)
- Supplemental medication(60 months)
- Adverse Events(60 months)
- IOP(60 months)
研究者
Dr Ho Ching Lin
Research Director
Singapore Eye Research Institute