Slow Coagulation Trans-Scleral Cyclophotocoagulation Versus Trabeculectomy in Medically Uncontrolled Open-Angle Glaucoma in Pseudophakic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- evaluate and compare the amount of iop reduction between SC-TSCPC and trabeculectomy with MMC in the management of medically uncontrolled OAG in pseudophakic eyes.
研究概览
简要总结
cyclodiode versus trabeculectomy with MMC in pseudophakic patients.
详细描述
Glaucoma is an optic neuropathy that is characterized by progressive structural and functional neuropathy. It is a leading cause of irreversible blindness.
Open angle glaucoma (OAG) is the commonest subtype of glaucoma. The number of patients diagnosed with POAG was estimated 52.68 million in 2020 and expected to be 79.76 million in 2040.
The management of OAG in patients with pseudophakia aims to IOP, which is the major modifiable risk factor for glaucoma progression. This can be achieved by medical, laser or surgical methods.
In many cases medical therapy can provide an effective IOP control, while surgery and laser are still indicated when the medical treatment fails to lower IOP sufficiently, or if the patient is not compliant with treatment.
Trabeculectomy with mitomycin C (MMC) is a filtration procedure that reduces IOP by creating a connection between the anterior chamber and the sub-conjunctival space after excision of a part of the trabecular meshwork. Pseudophakic eyes with OAG have a higher risk for surgical failure of trabeculectomy with MMC than the phakic eyes. Also it is associated with a higher incidence of complications as hypotony, lost anterior chamber or supra-choroidal effusion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients above 40 years old.
- •2. POAG who underwent previous uncomplicated cataract surgery with intraocular lens implantation.
- •3. Pseudophakic patients with medically uncontrolled glaucoma in spite of the use of two anti-glaucoma medications or intolerance to medical therapy.
- •4. Visual field defects in both the superior and inferior hemi-fields outside the central 5 degrees of fixation.
- •5. Mean deviation on perimetry ranges between -6 dB and -12 dB
排除标准
- •1. Patients with history of previous glaucoma surgery.
- •Patients who have used topical steroids within the last three months.
- •Patients with significant media opacity, such as corneal opacity, that obstructs fundoscopic examination.
- •4. Patients with ocular diseases as uveitis.
- •Patients with severe ocular surface disorders as ocular cicatricial pemphigoid.
- •6. Aphakic patients.
- •Ocular interventions apart from YAG posterior capsulotomy.
结局指标
主要结局
evaluate and compare the amount of iop reduction between SC-TSCPC and trabeculectomy with MMC in the management of medically uncontrolled OAG in pseudophakic eyes.
时间窗: 6 months
measuring the IOP with Goldman applanation tonometer.
evaluate and compare the degree of safety of SC-TSCPC versus trabeculectomy with MMC in the management of medically uncontrolled OAG in pseudophakic eyes.
时间窗: 6 months
if there is any inflammatory reaction, lost anterior chamber , cystoid macular edema
次要结局
未报告次要终点
研究者
Hazem Mohamed Mohamed
Assisstant lecture
Minia University