Trial record 3 of 9 for:    Open Studies | corneal laser surgery

Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery (FEMCAT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01982006
First received: October 21, 2013
Last updated: July 2, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • Overall costs of cataract surgery in both arms from the hospital perspective [ Time Frame: End of research (Month 12) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • No severe intraoperative or postoperative complications [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: Yes ]
  • Best Corrected Visual Acuity of 0 LogMAR [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: Yes ]
  • Refractive error inferior or equal to 0.75 diopter [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1050
Study Start Date: October 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: July 2015 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Cédric SCHWEITZER, MD cedric.schweitzer@chu-bordeaux.fr
Contact: Nicolas GEORGES, CRA nicolas.georges@chu-bordeaux.fr

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Cédric SCHWEITZER, MD       cedric.schweitzer@chu-bordeaux.fr   
Principal Investigator: Cédric SCHWEITZER, Md         
Sub-Investigator: David TOUBOUL, MD         
CHU de Brest Recruiting
Brest, France, 29609
Contact: Béatrice COCHENER, MD       beatrice.cochener@univ-brest.fr   
Principal Investigator: Béatrice COCHENER, MD         
Hospices Civils de Lyon Recruiting
Lyon, France, 69317
Contact: Philippe DENIS, Pr       philippe.denis@chu-lyon.fr   
Principal Investigator: Philippe DENIS, MD         
Hôpital Cochin Not yet recruiting
Paris, France, 75679
Contact: Antoine BREZIN, MD         
Principal Investigator: Antoine BREZIN, MD         
CHU de Tours Recruiting
Tours, France, 37044
Contact: Pierre-Jean PISELLA, MD       pisella@med.univ-tours.fr   
Principal Investigator: Pierre-Jean PISELLA, MD         
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:

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: July 2, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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 July 23, 2014