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NCT01982006: FEMCAT

Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery

Completed Phase 3 Last updated 4 October 2018
What this trial tests

Phase 3 trial testing Cataract surgery with Phacoemulsification in Cataract in 920 participants. Completed in 15 December 2016.

Timeline
9 October 2013
Primary endpoint
15 December 2016
15 December 2016

Quick facts

Lead sponsorUniversity Hospital, Bordeaux
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment920
Start date9 October 2013
Primary completion15 December 2016
Estimated completion15 December 2016
Sites5 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Bordeaux

Who can join

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

Sponsor's own description

Cataract is the leading cause of blindness worldwide and cataract surgery is the most frequent surgery performed in France. A new technology, the femtosecond laser-assisted cataract surgery, has to be compared with phacoemulsification alone, the conventional cataract surgery, to determine the economic impact of femtosecond laser-assisted process for the French healthcare insurance.

Publications & conference data

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

  1. Femtosecond laser-assisted versus phacoemulsification cataract surgery (FEMCAT): a multicentre participant-masked randomised superiority and cost-effectiveness trial.
    Schweitzer C, Brezin A, Cochener B, Monnet D, et al · · 2020 · cited 80× · PMID 31954466 · DOI 10.1016/s0140-6736(19)32481-x
  2. Laser-assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery.
    Day AC, Gore DM, Bunce C, Evans JR. · · 2016 · cited 74× · PMID 27387849 · DOI 10.1002/14651858.cd010735.pub2
  3. Cost Utility and Value of Information Analysis of Femtosecond Laser-Assisted Cataract Surgery.
    Bénard A, Sitta R, Brezin AP, Cochener B, et al · · 2023 · cited 12× · PMID 37200037 · DOI 10.1001/jamaophthalmol.2023.1716
  4. A new approach for sample size calculation in cost-effectiveness studies based on value of information.
    Bader C, Cossin S, Maillard A, Bénard A. · · 2018 · cited 10× · PMID 30348087 · DOI 10.1186/s12874-018-0571-1

Verify or expand the search:

Other recruiting trials for Cataract

Currently open trials in the same condition.

Other University Hospital, Bordeaux trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01982006.

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