Cost-effectiveness of ISBCS vs. DSBCS

Bilateral Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400124
• Other study ID #: NL64304.068.17
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: September 2020
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 858
• Est. completion date: February 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Cataract
• Cataract

Intervention

Procedure:
• ISBCS
The intervention group will undergo cataract surgery in both eyes on the same day (ISBCS)
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center (MUMC+)	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Complications	The incidence of intraoperative and postoperative complications	Intraoperatively and up to 4 weeks after second-eye surgery
Secondary	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
Secondary	Patient reported outcome measures (PROMs): Catquest	Patient satisfaction and vision-specific quality of life as measured by Catquest questionnaire.	Baseline and 3 months postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incremental cost-effectiveness ratios (ICERs): Catquest	Calculated costs per clinically improved patient on the Catquest questionnaire	Baseline until 3 months postoperatively
Secondary	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
Secondary	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