A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Group I: Change in the number of IOP lowering medications compared to baseline
研究概览
简要总结
The purpose of the study is to investigate the efficacy of an iStent trabecular microbypass stent compared to selective laser trabeculoplasty in combination with cataract surgery in eyes with exfoliation glaucoma (EXF)
详细描述
Exfoliation glaucoma patients with significant cataracts are being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patient´s glaucoma is classified into stable or unstable glaucoma groups with their current glaucoma medication. Patients meeting the eligibility requirements of stable glaucoma will be randomised to cataract surgery combined with iStent (65 patients), II SLT (65 patients) or III cataract surgery alone (25 patients) and patient with unstable glaucoma will be randomised to cataract surgery combined with I iStent (65 patients), II SLT (65 patients).
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
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent of information
- •Clinical significant cataract
- •Able to attend 12 month period
- •Mild to moderate exfoliation glaucoma according to European glaucoma society guidelines (EGS)
- •Group I stable glaucoma (IOP within individual target IOP), and group II unstable glaucoma (IOP above individual target IOP) with baseline glaucoma medication
- •Target IOP ≥16
- •Able to understand Finnish, Swedish or English
排除标准
- •Clinical set target IOP < 16 mmHg in advanced glaucoma
- •Baseline IOP prior to enrolment ≥30 mmHg, and ≥3 glaucoma medications
- •Closed angle
- •Congenital angle anomaly
- •Clinically significant corneal dystrophy or other hindering corneal condition
- •Unable to use topical medical therapy
- •Central corneal thickness of less than 480um or more than 620um
- •Active uveitis, cystic macular edema (CME), exudative age-related macular degeneration, proliferative diabetic retinopathy or clinical significant macular edema, intraocular neoplasm, intraocular injections, intraocular lens luxation, phacodonesis.
- •Previous intraocular surgery, refractive surgery or cycloablation
- •Two or more prior SLT or laser trabeculoplasty
- •Unable to participate due to another medical disease or condition
- •Participating in another clinical trial
结局指标
主要结局
Group I: Change in the number of IOP lowering medications compared to baseline
时间窗: 12 months
Accountability of IOP lowering medications used by the patient
Group II: Change in the IOP compared to baseline
时间窗: 12 months
IOP measured by Goldmann aplanation tonometry (GAT)
次要结局
- Group II: Change in the number of IOP lowering medications compared to baseline(12 months)
- Group I: Change in the IOP compared to baseline(12 months)
研究者
Prof. Mika Harju
MD, professor
Helsinki University Central Hospital