Cost-effectiveness of Immediately Versus Delayed Sequential Bilateral Cataract Surgery (ISBCS vs. DSBCS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 858
- 试验地点
- 1
- 主要终点
- Refraction: deviation of 1.0 D from target refraction
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and costs of immediately sequential bilateral cataract surgery (ISBCS) compared to delayed sequential bilateral cataract surgery (DSBCS) in order to determine whether ISBCS is an effective and cost-effective alternative to DSBCS.
详细描述
With an estimated number of 180,000 cataract extractions per year in the Netherlands, cataract surgery is one of the most frequently performed types of surgery. The majority of patients suffer from bilateral cataract and while cataract surgery of one eye is effective in restoring functional vision, second-eye surgery leads to further improvement in health-related quality of life.
Currently, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves cataract surgery of both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS).
Potential benefits of ISBCS include less time between surgeries, a faster total recovery period and lower costs. Potential risks, however, are complications of cataract surgery in general, most importantly the risk of endophthalmitis and refractive surprise. In ISBCS, both eyes are at risk at the same time, while in DSBCS both eyes are exposed to these risks consecutively.
Since there is no consensus yet about the role of ISBCS in current regular practice, further investigation of functional and surgical outcomes and cost-effectiveness of ISBCS compared to DSBCS is required. Therefore, the purpose of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to determine whether ISBCS is an effective and cost-effective alternative to DSBCS.
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
- Single (Outcomes Assessor)
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
- •Bilateral cataract
- •Indication for bilateral cataract surgery
- •Expected uncomplicated surgery
排除标准
- •Inability to comply with study procedures or to complete follow-up / Dutch questionnaires.
- •Non-routine cataract surgery
- •Cognitive or behavioural conditions that might interfere with surgery
- •Cataract surgery with premium IOL implantation
- •Conditions that increase the risk of endophthalmitis (e.g. current ocular/adnexal/periocular infections, immune-compromised, iodine allergy)
- •Factors that increase the risk of refractive surprise (e.g. axial lengths <21mm or >27mm, difference between eyes of >1.5mm, abnormal keratometry readings, previous refractive surgery)
- •Conditions that increase the risk of corneal edema
- •Factors that increase the risk of complicated surgery (e.g. previous surgery, trauma, anatomical abnormalities)
- •Sight-threatening comorbidity, Glaucoma or IOP > 24mmHg, Uveitis, Diabetes with diabetic retinopathy and macular edema
研究组 & 干预措施
ISBCS
The intervention group will undergo cataract surgery of both eyes on the same day (ISBCS)
干预措施: ISBCS (Procedure)
DSBCS
The usual care / control group will undergo cataract surgery of both eyes on separate days, with a time period of at least two weeks between surgeries (DSBCS).
干预措施: DSBCS (Procedure)
结局指标
主要结局
Refraction: deviation of 1.0 D from target refraction
时间窗: Four weeks post-operatively
Proportion of patients in both treatment groups with a postoperative refraction in the second eye that deviates 1.0 diopters (D) from target refraction
次要结局
- Costs per patient(Baseline until 3 months postoperatively)
- Incremental cost-effectiveness ratios (ICERs): Target refraction(Baseline until 3 months postoperatively)
- Quality Adjusted Life Years (QALYs)(Baseline until 3 months postoperatively)
- Patient reported outcome measures (PROMs): NEI VFQ-25(Baseline and 3 months postoperatively)
- Patient reported outcome measures (PROMs): EQ-5D-5L(Baseline, 1,4 weeks and 3 months postoperatively)
- Incremental cost-effectiveness ratios (ICERs): Visual acuity(Baseline until 3 months postoperatively)
- Complications(Intraoperatively and up to 4 weeks after second-eye surgery)
- Patient reported outcome measures (PROMs): HUI3(Baseline, 1,4 weeks and 3 months postoperatively)
- Incremental cost-effectiveness ratios (ICERs): QALY(Baseline until 3 months postoperatively)
- Budget impact(Baseline until 3 months postoperatively)
- Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25(Baseline until 3 months postoperatively)
- Incremental cost-effectiveness ratios (ICERs): Catquest(Baseline until 3 months postoperatively)
- Refraction: deviation of 0.5 D from target refraction(Four weeks post-operatively)
- Change in visual acuity(Baseline, 1 week after first-eye surgery and 4 weeks after second-eye surgery)
- Patient reported outcome measures (PROMs): Catquest(Baseline and 3 months postoperatively)