Cost-effectiveness of Immediately Versus Delayed Sequential Bilateral Cataract Surgery (ISBCS vs. DSBCS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 858
- Locations
- 2
- Primary Endpoint
- Refraction: deviation of 1.0 D from target refraction
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Bilateral cataract
- •Indication for bilateral cataract surgery
- •Expected uncomplicated surgery
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Refraction: deviation of 1.0 D from target refraction
Time Frame: 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
Secondary Outcomes
- 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)
- Costs per patient(Baseline until 3 months postoperatively)
- Incremental cost-effectiveness ratios (ICERs): Target refraction(Baseline until 3 months postoperatively)