Clinical trial NCT03400124: Cost-effectiveness of ISBCS vs. DSBCS
Official title: Cost-effectiveness of Immediately Versus Delayed Sequential Bilateral Cataract Surgery (ISBCS vs. DSBCS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Cataract
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2018-01-17
Enrollment: 858
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Refraction: deviation of 1.0 D from target refraction
timeFrame: Four weeks post-operatively
Secondary outcomes:
measure: Refraction: deviation of 0.5 D from target refraction
timeFrame: Four weeks post-operatively
measure: Change in visual acuity
timeFrame: Baseline, 1 week after first-eye surgery and 4 weeks after second-eye surgery
measure: Complications
timeFrame: Intraoperatively and up to 4 weeks after second-eye surgery
measure: Patient reported outcome measures (PROMs): NEI VFQ-25
timeFrame: Baseline and 3 months postoperatively
measure: Patient reported outcome measures (PROMs): Catquest
timeFrame: Baseline and 3 months postoperatively
measure: Patient reported outcome measures (PROMs): HUI3
timeFrame: Baseline, 1,4 weeks and 3 months postoperatively
measure: Patient reported outcome measures (PROMs): EQ-5D-5L
timeFrame: Baseline, 1,4 weeks and 3 months postoperatively
measure: Quality Adjusted Life Years (QALYs)
timeFrame: Baseline until 3 months postoperatively
measure: Costs per patient
timeFrame: Baseline until 3 months postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): QALY
timeFrame: Baseline until 3 months postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): Target refraction
timeFrame: Baseline until 3 months postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25
timeFrame: Baseline until 3 months postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): Catquest
timeFrame: Baseline until 3 months postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): Visual acuity
timeFrame: Baseline until 3 months postoperatively
measure: Budget impact
timeFrame: Baseline until 3 months postoperatively
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center (MUMC+)
state: Limburg
Study officials:
affiliation: Department of Ophthalmology, Maastricht University Medical Center
name: Rudy Nuijts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spekreijse LS, Simons RWP, Winkens B, van den Biggelaar FJHM, Dirksen CD, Nuijts RMMA. Cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (the BICAT-NL study): study design of a prospective multicenter randomised controlled trial. BMC Ophthalmol. 2020 Jun 29;20(1):257. doi: 10.1186/s12886-020-01521-x.