The Development of Surgical Pathways Using Femto-second Laser Technology to Increase the Efficiency and Safety of Cataract Surgery Within a Public Health Sector Setting - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- Cost-analysis: Healthcare resource use attributable to managing patients in this study will be collected.
研究概览
简要总结
This study aims to examine the health economic impact of adopting femtosecond laser technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare system, the National Health Service (NHS).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have reduced visual acuity or visual symptoms attributed to the presence of cataract in one or both eyes by the examining ophthalmologist or else must require cataract surgery on clinical grounds other than visual symptoms.
- •Patients must be willing to attend for follow-up at 1 month after cataract surgery.
- •Patients must be sufficiently fluent in English for informed consent and self-completion of the patient reported outcome questionnaires.
排除标准
- •Children below the age of 18
- •Already enrolled in another study
- •The principle exclusion criteria relate to clinical contraindications for FLACS, such as:
- •Significant corneal opacities
- •Small pupils following pharmacological dilatation
- •Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine.
结局指标
主要结局
Cost-analysis: Healthcare resource use attributable to managing patients in this study will be collected.
时间窗: up to 2 months
These include (but not necessarily be limited to) the cost of surgery for both arms of the trial (including resource use and staffing levels required for the surgical protocols), resource use attributable to managing complications arising from surgery, all relevant diagnostic investigations, further surgery where necessary, hospital length of stay and ward type, outpatient attendances, procedures performed on an outpatient basis, Accident \& Emergency attendances and prescribed drug medications. The quantity of resource use for each cost component will be measured from medical records. Site-specific unit costs will be taken in preference of standard published sources or national tariffs where possible.
次要结局
未报告次要终点