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NCT03400124

Cost-effectiveness of ISBCS vs. DSBCS

Completed NA Last updated 5 September 2021
What this trial tests

NA trial testing ISBCS in Bilateral Cataract in 858 participants. Completed in 1 February 2021.

Timeline
1 September 2018
Primary endpoint
1 October 2020
1 February 2021

Quick facts

Lead sponsorMaastricht University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment858
Start date1 September 2018
Primary completion1 October 2020
Estimated completion1 February 2021
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Maastricht University Medical Center

Who can join

18 and older, any sex, with Bilateral Cataract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Spekreijse L, Simons R, Winkens B, van den Biggelaar F, et al · · 2023 · cited 30× · PMID 37201546 · DOI 10.1016/s0140-6736(23)00525-1
  2. Immediate sequential bilateral surgery versus delayed sequential bilateral surgery for cataracts.
    Dickman MM, Spekreijse LS, Winkens B, Schouten JS, et al · · 2022 · cited 21× · PMID 35467755 · DOI 10.1002/14651858.cd013270.pub2
  3. 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.
    Spekreijse LS, Simons RWP, Winkens B, van den Biggelaar FJHM, et al · · 2020 · cited 9× · PMID 32600295 · DOI 10.1186/s12886-020-01521-x

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