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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
858
Maastricht University Medical Center (MUMC+)
Maastricht, Limburg, Netherlands
Refraction: deviation of 1.0 D from target refraction
Proportion of patients in both treatment groups with a postoperative refraction in the second eye that deviates 1.0 diopters (D) from target refraction
Time frame: Four weeks post-operatively
Refraction: deviation of 0.5 D from target refraction
Proportion of patients in both treatment groups with a postoperative refraction in the second eye that deviates 0.5 diopters (D) from target refraction
Time frame: Four weeks post-operatively
Change in visual acuity
Visual acuity will be measured by ETDRS letter charts
Time frame: Baseline, 1 week after first-eye surgery and 4 weeks after second-eye surgery
Complications
The incidence of intraoperative and postoperative complications
Time frame: Intraoperatively and up to 4 weeks after second-eye surgery
Patient reported outcome measures (PROMs): NEI VFQ-25
Patient satisfaction and vision-specific quality of life as measured by National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
Time frame: Baseline and 3 months postoperatively
Patient reported outcome measures (PROMs): Catquest
Patient satisfaction and vision-specific quality of life as measured by Catquest questionnaire.
Time frame: Baseline and 3 months postoperatively
Patient reported outcome measures (PROMs): HUI3
Health-related quality of life as measured by HUI3 (Health Utility Index Mark 3) questionnaire.
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Time frame: Baseline, 1,4 weeks and 3 months postoperatively
Patient reported outcome measures (PROMs): EQ-5D-5L
Health-related quality of life as measured by EQ-5D-5L questionnaire.
Time frame: Baseline, 1,4 weeks and 3 months postoperatively
Quality Adjusted Life Years (QALYs)
Calculated based on generic health-related quality of life, using the EQ-5D-5L and HUI-3 questionnaires
Time frame: Baseline until 3 months postoperatively
Costs per patient
Cost per patient, including valuation of resource use by using the Dutch guidelines for cost-analyses or cost prices provided by the medical center.
Time frame: Baseline until 3 months postoperatively
Incremental cost-effectiveness ratios (ICERs): QALY
Evaluation of cost-effectiveness by using calculated costs per quality-adjusted life years (QALYs)
Time frame: Baseline until 3 months postoperatively
Incremental cost-effectiveness ratios (ICERs): Target refraction
Calculated costs per patient with a postoperative refraction within 1.0 D of target refraction
Time frame: Baseline until 3 months postoperatively
Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25
Calculated costs per clinically improved patient on the NEI VFQ-25 questionnaire
Time frame: Baseline until 3 months postoperatively
Incremental cost-effectiveness ratios (ICERs): Catquest
Calculated costs per clinically improved patient on the Catquest questionnaire
Time frame: Baseline until 3 months postoperatively
Incremental cost-effectiveness ratios (ICERs): Visual acuity
Calculated costs per patient with clinical improvement in (un)corrected distance visual acuity
Time frame: Baseline until 3 months postoperatively
Budget impact
Reported as a difference in costs. Different scenario's will be compared to investigate the impact of various levels of implementation (e.g. 25%, 50%, 75% of eligible patients).
Time frame: Baseline until 3 months postoperatively