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Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery (FEMCAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01982006
First received: October 21, 2013
Last updated: February 2, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Cataract Procedure: Cataract surgery with Phacoemulsification Device: Femtosecond laser-assisted cataract surgery Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Impact Médico-Economique de la Chirurgie de la cATaracte au Laser Femtoseconde

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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°.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 920
Actual Study Start Date: October 9, 2013
Study Completion Date: December 15, 2016
Primary Completion Date: December 15, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phaco
Cataract surgery by phacoemulsification
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.

Experimental: Femto
Corneal incision, anterior capsulorhexis and lens fragmentation by femtosecond laser
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


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.
  Eligibility

Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982006

Locations
France
CHU de Bordeaux
Bordeaux, France, 33000
CHU de Brest
Brest, France, 29609
Hospices Civils de Lyon
Lyon, France, 69317
Hôpital Cochin
Paris, France, 75679
CHU de Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Cédric SCHWEITZER, MD University Hospital Bordeaux, France
Study Chair: BENARD Antoine, MD University Hospital Bordeaux, France
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01982006     History of Changes
Other Study ID Numbers: CHUBX 2012/23
Study First Received: October 21, 2013
Last Updated: February 2, 2017

Keywords provided by University Hospital, Bordeaux:
cataract surgery
femtosecond laser cataract surgery
phacoemulsification
Cost-Benefit Analysis
Cost Effectiveness
Hospital Costs

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 27, 2017