Bilateral Cataract
Conditions
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.
Interventions
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Refraction: deviation of 1.0 D from target refraction | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in visual acuity | Baseline, 1 week after first-eye surgery and 4 weeks after second-eye surgery | Visual acuity will be measured by ETDRS letter charts |
| Complications | Intraoperatively and up to 4 weeks after second-eye surgery | The incidence of intraoperative and postoperative complications |
| Patient reported outcome measures (PROMs): NEI VFQ-25 | Baseline and 3 months postoperatively | Patient satisfaction and vision-specific quality of life as measured by National Eye Institute Visual Function Questionnaire (NEI VFQ-25). |
| Patient reported outcome measures (PROMs): Catquest | Baseline and 3 months postoperatively | Patient satisfaction and vision-specific quality of life as measured by Catquest questionnaire. |
| Patient reported outcome measures (PROMs): HUI3 | Baseline, 1,4 weeks and 3 months postoperatively | Health-related quality of life as measured by HUI3 (Health Utility Index Mark 3) questionnaire. |
| Patient reported outcome measures (PROMs): EQ-5D-5L | Baseline, 1,4 weeks and 3 months postoperatively | Health-related quality of life as measured by EQ-5D-5L questionnaire. |
| Quality Adjusted Life Years (QALYs) | Baseline until 3 months postoperatively | Calculated based on generic health-related quality of life, using the EQ-5D-5L and HUI-3 questionnaires |
| Refraction: deviation of 0.5 D from target refraction | Four weeks post-operatively | Proportion of patients in both treatment groups with a postoperative refraction in the second eye that deviates 0.5 diopters (D) from target refraction |
| Incremental cost-effectiveness ratios (ICERs): QALY | Baseline until 3 months postoperatively | Evaluation of cost-effectiveness by using calculated costs per quality-adjusted life years (QALYs) |
| Incremental cost-effectiveness ratios (ICERs): Target refraction | Baseline until 3 months postoperatively | Calculated costs per patient with a postoperative refraction within 1.0 D of target refraction |
| Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25 | Baseline until 3 months postoperatively | Calculated costs per clinically improved patient on the NEI VFQ-25 questionnaire |
| Incremental cost-effectiveness ratios (ICERs): Catquest | Baseline until 3 months postoperatively | Calculated costs per clinically improved patient on the Catquest questionnaire |
| Incremental cost-effectiveness ratios (ICERs): Visual acuity | Baseline until 3 months postoperatively | Calculated costs per patient with clinical improvement in (un)corrected distance visual acuity |
| Budget impact | Baseline until 3 months postoperatively | 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). |
| Costs per patient | Baseline until 3 months postoperatively | Cost per patient, including valuation of resource use by using the Dutch guidelines for cost-analyses or cost prices provided by the medical center. |
Countries
Netherlands
Outcome results
None listed