Cost-effectiveness of ISBCS vs. DSBCS

September 3, 2021 updated by: Maastricht University Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
858

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Refraction: deviation of 1.0 D from target refraction
Time Frame: 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
Four weeks post-operatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Refraction: deviation of 0.5 D from target refraction
Time Frame: 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
Four weeks post-operatively
Change in visual acuity
Time Frame: Baseline, 1 week after first-eye surgery and 4 weeks after second-eye surgery
Visual acuity will be measured by ETDRS letter charts
Baseline, 1 week after first-eye surgery and 4 weeks after second-eye surgery
Complications
Time Frame: Intraoperatively and up to 4 weeks after second-eye surgery
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
Time Frame: 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).
Baseline and 3 months postoperatively
Patient reported outcome measures (PROMs): Catquest
Time Frame: Baseline and 3 months postoperatively
Patient satisfaction and vision-specific quality of life as measured by Catquest questionnaire.
Baseline and 3 months postoperatively
Patient reported outcome measures (PROMs): HUI3
Time Frame: Baseline, 1,4 weeks and 3 months postoperatively
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
Time Frame: Baseline, 1,4 weeks and 3 months postoperatively
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)
Time Frame: Baseline until 3 months postoperatively
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
Time Frame: 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.
Baseline until 3 months postoperatively
Incremental cost-effectiveness ratios (ICERs): QALY
Time Frame: Baseline until 3 months postoperatively
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
Time Frame: Baseline until 3 months postoperatively
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
Time Frame: Baseline until 3 months postoperatively
Calculated costs per clinically improved patient on the NEI VFQ-25 questionnaire
Baseline until 3 months postoperatively
Incremental cost-effectiveness ratios (ICERs): Catquest
Time Frame: Baseline until 3 months postoperatively
Calculated costs per clinically improved patient on the Catquest questionnaire
Baseline until 3 months postoperatively
Incremental cost-effectiveness ratios (ICERs): Visual acuity
Time Frame: Baseline until 3 months postoperatively
Calculated costs per patient with clinical improvement in (un)corrected distance visual acuity
Baseline until 3 months postoperatively
Budget impact
Time Frame: 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).
Baseline until 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rudy Nuijts, PhD, Department of Ophthalmology, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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