Health-Related Quality of Life in Two Pathways for Newly Diagnosed Open Angle Glaucoma and Ocular Hypertension: an Unmasked, Multi-centre, Randomised Controlled Trial of Initial Selective Laser Trabeculoplasty Versus Medical Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 718
- 试验地点
- 1
- 主要终点
- Health Related Quality of Life using EQ-5D
研究概览
简要总结
This is a randomized study with two treatment arms: 'initial Selective Laser Trabeculoplasty (SLT) followed by conventional medical therapy as required' ('Laser-1st') and 'medical therapy without laser ('Medicine-1st'). It compares quality of life in the two arms at three years, while also examining the incremental cost and cost-effectiveness of Laser-1st versus Medicine-1st.
详细描述
Subjects are randomly allocated to one of two treatment arms that examine treatment pathways, rather than comparing single treatments alone: 'initial Selective Laser Trabeculoplasty (SLT) followed by conventional medical therapy as required' ('Laser-1st') and 'medical therapy without laser ('Medicine-1st'). We compare quality of life in the two pathways (arms) over three years, while also examining the incremental cost and cost-effectiveness of Laser-1st versus Medicine-1st.
A 'Treat in Pursuit of Control' design (TPC) compares two different routes to a pre-defined target Intraocular pressure (IOP) (pathways). It is a pragmatic study that uses published guidelines to make the complex clinical treatment choices faced in managing glaucoma, standardised between treatment arms by use of computer treatment algorithms. A UK National Institute for Health and care Excellence (NICE)-compliant evidence-based IOP Treatment Target 1 is set for each patient, according to the study treatment algorithms. They then proceed through stepped increments of treatment intensity (up to and including surgery) until a predetermined Target IOP is reached. Target IOP is reassessed in the light of objective clinical evidence of stability of glaucomatous optic neuropathy (GON) and visual function using visual field tests and automated optic nerve evaluation. Health Related Quality of Life (HRQL) and secondary outcomes are compared for patients in each pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All clinical tests and outcomes are by masked observers.
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 open angle glaucoma (defined as an open drainage angle and reproducible glaucomatous visual field defects as tested by the Swedish Interactive Threshold Algorithm (SITA) algorithm on the Humphrey Visual Field or glaucomatous optic neuropathy)
- •Ocular hypertension (intra-ocular pressure above 21mmHg and requiring treatment as per National Institute of Health and Care Excellence (NICE) Guidelines).
- •Able to provide informed consent.
排除标准
- •Advanced glaucoma in the potentially eligible eye as determined by Early Manifest Treatment Guidelines (EMGT) criteria 77: visual field loss mean deviation worse than -12dB in the better or -15dB in the worse eye.
- •Secondary glaucoma (e.g. pigment dispersion syndrome, rubeosis, trauma etc) or any angle closure.
- •Any contra-indication to selective laser trabeculoplasty (e.g. unable to sit at the laser-mounted slit-lamp; past history of uveitis).
- •Unable to use topical medical therapy due to e.g. physical infirmity and a lack of carers able to administer daily eye-drops.
研究组 & 干预措施
'Laser-1st'
Initial Selective Laser Trabeculoplasty (SLT) [PROCEDURE] followed by conventional medical therapy (eye-drops) as required.
All participants in this arm start their treatment pathway with SLT. If this does not reach the predefined, patient-specific target IOP then repeat laser (once only) is given. If the IOP target is then not reached additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy with mitomycin C) as needed.
干预措施: Primary Selective Laser Trabeculoplasty Treatment Pathway (Procedure)
Medicine-1st
Conventional medical therapy [DRUG] without laser. All participants in this arm start their treatment pathway medical treatment. If the IOP target is then not reached, additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy with mitomycin C) as needed.
During this pathway of treatment all commercially available medical treatments (eye-drops) are permitted according to a pre-specified step-wise intervention protocol described in detail in the publicly available trial protocol. This begins with prostaglandin analogues, then beta-blockers followed by alpha agonists or carbonic anhydrase inhibitors. The full range of available doses, treatments and drugs is beyond this short summary.
干预措施: Primary Medical Treatment Pathway (Drug)
结局指标
主要结局
Health Related Quality of Life using EQ-5D
时间窗: 3 years
Quality Adjusted Life Years by EQ-5D health states
次要结局
- Heidelberg Retinal Tomographie optic nerve analysis(3 years)
- Goldmann Applanation Tonometry measured intra-ocular pressure(3 years)
- Hospital visit frequency(3 years)
- Health Related Quality of Life using GUI(3 years)
- Cost-effectiveness ratio(3 years)
- Cost-effectiveness(3 years)
- Glaucoma Symptom Score (GSS)(3 years)
- Glaucoma Utility Index (GUI)(3 years)
- Visual Acuity(3 years)
- Humphrey Visual Field Assessments(3 years)
- Treatment intensity(3 years)
- Glaucoma Quality of Life-15 (GQL-15)(3 years)
研究者
Mr Gus Gazzard
CONSULTANT OPHTHALMOLOGIST
Moorfields Eye Hospital NHS Foundation Trust