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Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery (FEMCAT)

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ClinicalTrials.gov Identifier: NCT01982006
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE October 21, 2013
First Posted Date  ICMJE November 13, 2013
Last Update Posted Date October 4, 2018
Actual Study Start Date  ICMJE October 9, 2013
Actual Primary Completion Date December 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
Incremental Cost/effectiveness ratio defined as cost per incremental therapeutic success. [ Time Frame: 3 months after inclusion ]
Therapeutic success will be defined by the association of the following criterion:
  • No severe intraoperative or postoperative complications,
  • Best Corrected Visual Acuity of 0 LogMAR,
  • A refractive error inferior or equal to 0.75 diopter,
  • Corneal surgically-induced astigmatism inferior or equal to 0.5 diopter and a postoperative change of astigmatism axis inferior or equal to 20°.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01982006 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
  • Quality of life [ Time Frame: Before surgery (From day -8 to day -1) and months 1, 3 and 12 after surgery ]
    Quality of life evaluation using Visual Function 14 questionnaire
  • Learning curve of the femtosecond laser-assisted cataract surgery [ Time Frame: End of research (Month 12) ]
  • Overall costs of cataract surgery in both arms from the hospital perspective [ Time Frame: End of research (Month 12) ]
  • Incremental cost - Utility ratio defined as incremental Cost/QALY (Quality Adjusted Life Year) for healthcare insurance in both arms [ Time Frame: 12 months after inclusion ]
  • No severe intraoperative or postoperative complications [ Time Frame: 3 months after inclusion ]
  • Best Corrected Visual Acuity of 0 LogMAR [ Time Frame: 3 months after inclusion ]
  • Refractive error inferior or equal to 0.75 diopter [ Time Frame: 3 months after inclusion ]
  • Corneal surgically-induced astigmatism inferior or equal to 0.5 diopter and a postoperative change of astigmatism axis inferior or equal to 20° [ Time Frame: 3 months after inclusion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery
Official Title  ICMJE Impact Médico-Economique de la Chirurgie de la cATaracte au Laser Femtoseconde
Brief Summary 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.
Detailed Description

An estimated 700,000 cataract procedures are performed every year in France, with this amount of surgeries predicted to climb as the population there, as well as around the world, ages. Currently, phacoemulsification alone is the conventional cataract surgery. The femtosecond laser-assisted cataract surgery has to be compared with the standard process to provide information on how it could benefit the patient population treated every year for cataract surgery. This economic study has received a grant from the French Ministry of Health to evaluate the economic impact of femtosecond laser-assisted process for the French healthcare system. For this goal, this prospective, randomized, parallel, multicenter and simple blind study will determine the incremental cost/effectiveness ratio for femtosecond laser-assisted process versus phacoemulsification surgery. Visual acuity results and intraoperative or postoperative complication rate will be compared between both groups. The learning curve of the femtosecond laser assisted cataract surgery will be also evaluated for each surgeon involved in the study.

Ethic and regulatory autority authorisations were obtained at 19/Dec/2012 and 15/Feb/2013, respectively. Date of first inclusion: 9/Oct/2013. Date of first NCT release: 13/Nov/2013. 30 patients were included between this period. French regulatory process dos not require NCT registration before first inclusion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Procedure: Cataract surgery with Phacoemulsification

    Each patients randomized in the phaco arm will undergo a conventional cataract surgery.

    Corneal incisions will be manually performed using the same calibrated blade and at the same location for all procedures of one surgeon.

    Phacoemulsification machine used to perform cataract surgery in each center will be the same for all patients included in the center. The IOL (IntraOcular Lens) used in each center will be the same for all patients treated in the center.

  • Device: Femtosecond laser-assisted cataract surgery

    Each patients randomized in the femto arm will undergo a femtosecond laser assisted cataract surgery.

    Corneal incisions will be performed by the laser. Number, size and location of the incisions must be the same than in the phaco arm for all patients treated by one surgeon.

    Phacoemulsification machine used to remove the liquefied lens will be the same than in the phaco arm The IOL used in each center will be the same than in the phaco arm

Study Arms  ICMJE
  • Active Comparator: Phaco
    Cataract surgery by phacoemulsification
    Intervention: Procedure: Cataract surgery with Phacoemulsification
  • Experimental: Femto
    Corneal incision, anterior capsulorhexis and lens fragmentation by femtosecond laser
    Intervention: Device: Femtosecond laser-assisted cataract surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2017)
920
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2013)
1050
Actual Study Completion Date  ICMJE December 15, 2016
Actual Primary Completion Date December 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cataract with impaired visual acuity (> or equal +0.3 LogMAR) or with cataract-related visual symptoms (Halos, Monocular diplopia, glare)
  • French healthcare insurance beneficiary

Exclusion Criteria:

  • Pupil size lower than 6mm
  • Iris constriction
  • Iris synechiae
  • Preoperative zonular instability or crystalline lens subluxation
  • Obstructive Corneal scars
  • Obstructive pterygion
  • Axial length <20.5 mm
  • Corneal astigmatism >1.5 diopters
  • Fuchs corneal dystrophy
  • History of Central retinal vein or artery occlusion
  • History of uveitis
  • History of optic nerve head neuropathy except glaucoma
  • Progressive glaucoma
  • Nystagmus
  • Uncontrolled diabetes mellitus
  • General history of dementia or psychotic disorders
  • Pregnancy, breast feeding
  • General medications: Alpha-blockers, Carbonic anhydrase inhibitors
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01982006
Other Study ID Numbers  ICMJE CHUBX 2012/23
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cédric SCHWEITZER, MD University Hospital Bordeaux, France
Study Chair: BENARD Antoine, MD University Hospital Bordeaux, France
PRS Account University Hospital, Bordeaux
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP