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
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Procedure: Cataract surgery with Phacoemulsification Device: Femtosecond laser-assisted cataract surgery||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||920 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Impact Médico-Economique de la Chirurgie de la cATaracte au Laser Femtoseconde|
|Actual Study Start Date :||October 9, 2013|
|Actual Primary Completion Date :||December 15, 2016|
|Actual Study Completion Date :||December 15, 2016|
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.
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
- 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°.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982006
|CHU de Bordeaux|
|Bordeaux, France, 33000|
|CHU de Brest|
|Brest, France, 29609|
|Hospices Civils de Lyon|
|Lyon, France, 69317|
|Paris, France, 75679|
|CHU de Tours|
|Tours, France, 37044|
|Principal Investigator:||Cédric SCHWEITZER, MD||University Hospital Bordeaux, France|
|Study Chair:||BENARD Antoine, MD||University Hospital Bordeaux, France|