A Prospective, Randomized, Controlled, Single-Center Clinical Trial to Evaluate the Efficacy and Safety of Innovative Tube Trabeculectomy Compared to Conventional Trabeculectomy in Patients With Advanced and Refractory Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- • Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications.
研究概览
简要总结
This study aims to compare the efficacy and safety of a novel surgical technique, Innovative Tube Trabeculectomy (ITT), against conventional trabeculectomy in patients with advanced and refractory glaucoma. ITT incorporates a unique preoperative regimen and surgical modifications, including a deep extended scleral tunnel, X-shaped non-absorbable suture, and a nasolacrimal tube implant, designed to enhance aqueous humor outflow and reduce postoperative fibrosis. Participants will be randomized to receive either ITT or conventional trabeculectomy and followed for 12 months to assess intraocular pressure control, medication use, complication rates, and bleb morphology.
详细描述
Glaucoma is a leading cause of irreversible blindness. While trabeculectomy is a standard surgical intervention, its long-term success can be compromised by fibrosis. The ITT technique introduces several innovations to address these limitations. This single-center, prospective, randomized controlled trial will enroll adult patients with advanced or refractory open-angle glaucoma. Patients will undergo a rigorous preoperative regimen before being randomized to either the ITT group or the conventional trabeculectomy group. The primary outcome will be surgical success (IOP ≤ 15 mmHg and ≥ 20% reduction from baseline without medication) at 12 months. Secondary outcomes include mean IOP, medication burden, complication rates, bleb morphology (UBM/AS-OCT), visual acuity, visual fields, and quality of life. The study will provide crucial evidence on the potential benefits of ITT for this challenging patient population.
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
- Single (Outcomes Assessor)
盲法说明
Blinding of participants and care providers is not feasible due to the nature of surgical interventions and distinct postoperative care protocols
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 advanced or refractory primary open-angle glaucoma (POAG) or secondary open-angle glaucoma (excluding neovascular glaucoma).
- •Intraocular pressure (IOP) > 21 mmHg despite maximal tolerated medical therapy or previous failed glaucoma surgery.
- •Best corrected visual acuity (BCVA) of 20/400 or better.
- •Capable of providing informed consent
排除标准
- •Previous incisional glaucoma surgery in the study eye (except for prior failed trabeculectomy in the refractory group).
- •Neovascular glaucoma or other forms of secondary glaucoma that may significantly impact wound healing (e.g., uveitic glaucoma).
- •Significant ocular comorbidities that may confound outcome assessment (e.g., severe corneal disease, retinal detachment).
- •Pregnancy or lactation.
- •Participation in another clinical trial within 30 days prior to enrollment.
研究组 & 干预措施
Arm 1: Innovative Tube Trabeculectomy (ITT)
Patients will undergo the innovative tube trabeculectomy procedure. This includes a 3-week preoperative regimen (discontinuation of preserved medications and prostaglandin analogs, initiation of fluorometholone), a 1-week preoperative subconjunctival injection (Mitomycin C 0.04%, Avastin 1.25 mg, Dexamethasone 8 mg), and the surgical technique involving a deep extended scleral tunnel, intraoperative Mitomycin C application, X-shaped non-absorbable suture, and nasolacrimal tube implantation.
干预措施: Innovative Tube Trabeculectomy (Procedure)
Arm 2: Conventional Trabeculectomy
Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site).
干预措施: Conventional Trabeculectomy (Procedure)
结局指标
主要结局
• Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications.
时间窗: 12 months post-surgery
The proportion of eyes achieving the defined surgical success criteria
次要结局
- • Measure: Mean Intraocular Pressure (IOP)(• Time Frame: 3, 6, and 12 months post-surgery)
- • Measure: Number of Glaucoma Medications(3, 6, and 12 months post-surgery)
- • Measure: Incidence of Surgical Complications(From surgery to 12 months post-surgery)
- • Measure: Bleb Morphology and Function(6 and 12 months post-surgery)
- • Measure: Best Corrected Visual Acuity (BCVA)(3, 6, and 12 months post-surgery)
- • Measure: Visual Field Mean Deviation (MD)(6 and 12 months post-surgery)
- • Measure: Quality of Life (QoL)(6 and 12 months post-surgery)
研究者
Ahmed Mohamed Saeed Abdel Hamid
Principal investigator
Benha University