Comparison of Selective Laser Trabeculoplasty With Prostaglandin Analogues for Lowering Intraocular Pressure in Eyes With Primary Angle Closure Glaucoma
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Intraocular Pressure
研究概览
简要总结
Glaucoma affects 66 million people worldwide and is the leading cause of irreversible blindness, and Primary angle-closure glaucoma (PACG) is a major form of glaucoma in Asia.
Laser peripheral iridotomy (LPI) has been advocated as the first line treatment in all cases of PACG. In addition to relieving the relative pupil block element of the condition, it can open up the drainage angle, alleviating appositional and synechial angle-closure and in the long-term this may control intraocular pressure (IOP) and prevent progression of glaucomatous optic neuropathy. However recent data indicate that iridotomy is not successful in controlling IOP in the long term, and the majority of cases develop a clinically significant rise in IOP requiring medical therapy or surgery.
Laser trabeculoplasty has been a recognized treatment option for Primary open angle glaucoma (POAG) since the 1980s. Recently a more selective and less destructive method of performing laser trabeculoplasty has evolved. Selective Laser Trabeculoplasty (SLT) specifically targets the pigmented trabecular meshwork cells without producing collateral damage and destruction to adjacent structures. Morphologic study performed on human autopsy eyes treated with SLT noted no structural or collateral thermal damage to the trabecular beams in the uveal and corneoscleral meshwork. As SLT specifically has its effect on the targeted pigmented trabecular meshwork it is unlikely to generate PAS. It may be a useful treatment option for PACG patients in whom the angle has widened following laser peripheral iridotomy.
The proposed study is a randomized controlled trial to assess the effectiveness of SLT in reducing IOP in cases of PACG in which the angle has opened up following LPI, but IOP remains high(>21 mmHg). 100 subjects will be randomized to receive either SLT or medical treatment to achieve IOP control. They will be followed up for 6 months.
详细描述
STUDY OBJECTIVES AND PURPOSE
The aim of this study is to determine whether selective laser trabeculoplasty (SLT) is an effective treatment for lowering intraocular pressure (IOP) in patients with primary angle closure glaucoma (PACG), compared to prostaglandin analogues, the current first choice IOP-lowering medical therapy.
STUDY DESIGN The study design for this project is a prospective randomized controlled trial. It will not be possible to blind either the subject or observer to the intervention due to the use of laser in the intervention group and medical therapy in the control group. Subjects will then be followed-up for 6 months
STUDY POPULATION
The study population will be patients with primary angle closure glaucoma attending the Singapore National Eye Centre, who fulfil the inclusion criteria and are willing to take part in the study.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary angle closure or primary angle closure glaucoma with documented pre-LPI angle closure of ≥180 degrees of the angle (Trabecular meshwork not visible in primary position using gonioscopy)
- •One month post LPI, angle has opened up (visibility of trabecular meshwork) for at least 180 degrees of the angle
- •Intraocular pressure between 21-≤30 mmHg without treatment following LPI OR Intraocular pressure between 21-≤30 mmHg after wash out regimen as described below for patients who are already medications following LPI.
- •Informed Consent
- •Age more than 21 years
排除标准
- •Secondary causes of angle closure like subluxed lens, uveitis, trauma and neovascular glaucoma
- •Presence of advanced sight-threatening glaucoma defined as vertical cup-disc ratio > 0.9 or visual field constriction involving <100 of the central visual field performed with the Humphrey Visual Field Analyzer II using the SITA STD algorithm with a 24-2 test pattern.
- •Cataract that is deemed significant enough to require surgery during the course of the trial or that makes field testing or optic disc imaging not technically possible- visual acuity less than 20/40 due to any type of cataract.
- •Previous intraocular surgery, SLT, ALT, refractive surgery or iridoplasty.
- •Documented previous history of angle closure.
- •Use of contact lens
- •Chronic use of topical or systemic steroids
- •Participation in another therapeutic drug study within the last 30 days
- •Severe health problems precluding follow-up such as end-stage heart disease, kidney disease, respiratory disease, or cancer and life expectancy less than one year.
研究组 & 干预措施
Trabeculoplasty
干预措施: Selective Laser Trabeculoplasty (Procedure)
Control (Medication)
干预措施: Travoprost/ Timolol/ Azopt/ Brimonidine (Drug)
结局指标
主要结局
Intraocular Pressure
时间窗: 6 months
Fluid pressure inside the eye
次要结局
未报告次要终点