Cost-effectiveness of ISBCS vs. DSBCS

Cost-effectiveness of Immediately Versus Delayed Sequential Bilateral Cataract Surgery (ISBCS vs. DSBCS)

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.

Study Overview

• Status: Completed
• Conditions: Bilateral Cataract
• Intervention / Treatment: Procedure: ISBCS; Procedure: 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 Type: Interventional
• Enrollment (Actual): 858
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht University Medical Center (MUMC+)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ISBCS; The intervention group will undergo cataract surgery of both eyes on the same day (ISBCS)	Procedure: ISBCS; The intervention group will undergo cataract surgery in both eyes on the same day (ISBCS)
Active Comparator: 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).	Procedure: DSBCS; The usual care / control group will undergo cataract surgery in both eyes on separate days, with a time period of at least two weeks between surgeries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Four weeks post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Four weeks post-operatively
Change in visual acuity	Visual acuity will be measured by ETDRS letter charts	Baseline, 1 week after first-eye surgery and 4 weeks after second-eye surgery
Complications	The incidence of intraoperative and postoperative complications	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).	Baseline and 3 months postoperatively
Patient reported outcome measures (PROMs): Catquest	Patient satisfaction and vision-specific quality of life as measured by Catquest questionnaire.	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.	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.	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	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.	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)	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	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	Baseline until 3 months postoperatively
Incremental cost-effectiveness ratios (ICERs): Catquest	Calculated costs per clinically improved patient on the Catquest questionnaire	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	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).	Baseline until 3 months postoperatively

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Rudy Nuijts, PhD, Department of Ophthalmology, Maastricht University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: NL64304.068.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No