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Bilateral CataractNCT03400124

Cost-effectiveness of ISBCS vs. DSBCS

A study testing ISBCS and DSBCS in people with Bilateral Cataract, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bilateral Cataract
What is being tested?
ISBCS and DSBCS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
858 participants
Where
1 siteNetherlands
Study dates
1 Sep 2018to 1 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Bilateral cataract
  • Indication for bilateral cataract surgery
  • Expected uncomplicated surgery

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Center (MUMC+)

    Maastricht, Limburg, 6229 HX

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
ISBCS, DSBCS
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ISBCSProcedure or surgery

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

  • DSBCSProcedure or surgery

    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.

Study groups in NCT03400124
Study groupRoleWhat they receive
ISBCSActive comparatorThe intervention group will undergo cataract surgery of both eyes on the same day (ISBCS)
Receives: Procedure: ISBCS
DSBCSActive comparatorThe 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).
Receives: Procedure: DSBCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Four weeks post-operatively

Secondary outcomes (15)

  1. 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

    Measured: Four weeks post-operatively

  2. Change in visual acuity

    Visual acuity will be measured by ETDRS letter charts

    Measured: Baseline, 1 week after first-eye surgery and 4 weeks after second-eye surgery

  3. Complications

    The incidence of intraoperative and postoperative complications

    Measured: Intraoperatively and up to 4 weeks after second-eye surgery

  4. 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).

    Measured: Baseline and 3 months postoperatively

  5. Patient reported outcome measures (PROMs): Catquest

    Patient satisfaction and vision-specific quality of life as measured by Catquest questionnaire.

    Measured: Baseline and 3 months postoperatively

  6. Patient reported outcome measures (PROMs): HUI3

    Health-related quality of life as measured by HUI3 (Health Utility Index Mark 3) questionnaire.

    Measured: Baseline, 1,4 weeks and 3 months postoperatively

  7. Patient reported outcome measures (PROMs): EQ-5D-5L

    Health-related quality of life as measured by EQ-5D-5L questionnaire.

    Measured: Baseline, 1,4 weeks and 3 months postoperatively

  8. Quality Adjusted Life Years (QALYs)

    Calculated based on generic health-related quality of life, using the EQ-5D-5L and HUI-3 questionnaires

    Measured: Baseline until 3 months postoperatively

  9. 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.

    Measured: Baseline until 3 months postoperatively

  10. Incremental cost-effectiveness ratios (ICERs): QALY

    Evaluation of cost-effectiveness by using calculated costs per quality-adjusted life years (QALYs)

    Measured: Baseline until 3 months postoperatively

  11. Incremental cost-effectiveness ratios (ICERs): Target refraction

    Calculated costs per patient with a postoperative refraction within 1.0 D of target refraction

    Measured: Baseline until 3 months postoperatively

  12. Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25

    Calculated costs per clinically improved patient on the NEI VFQ-25 questionnaire

    Measured: Baseline until 3 months postoperatively

  13. Incremental cost-effectiveness ratios (ICERs): Catquest

    Calculated costs per clinically improved patient on the Catquest questionnaire

    Measured: Baseline until 3 months postoperatively

  14. Incremental cost-effectiveness ratios (ICERs): Visual acuity

    Calculated costs per patient with clinical improvement in (un)corrected distance visual acuity

    Measured: Baseline until 3 months postoperatively

  15. 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).

    Measured: Baseline until 3 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start1 Sep 2018
  3. Primary completion1 Oct 2020
  4. Study completion1 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
858 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03400124
Sponsor's protocol ID
NL64304.068.17
Status last verified
Sep 2020
First submitted
22 Dec 2017
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Spekreijse L, Simons R, Winkens B, van den Biggelaar F, Dirksen C, Bartels M, de Crom R, Goslings O, Joosse M, Kasanardjo J, Lansink P, Ponsioen T, Reus N, Schouten J, Nuijts R. Safety, effectiveness, and cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (BICAT-NL study): a multicentre, non-inferiority, randomised controlled trial. Lancet. 2023 Jun 10;401(10392):1951-1962. doi: 10.1016/S0140-6736(23)00525-1. Epub 2023 May 15.

    PubMed 37201546

  • 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.

    PubMed 32600295

Questions about this trial

What is this clinical trial studying?

A study testing ISBCS and DSBCS in people with Bilateral Cataract, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Refraction: deviation of 1.0 D from target refraction (time frame: Four weeks post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03400124, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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