Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery

Study Overview
=================
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.

Official Title
-----------------
Impact Médico-Economique de la Chirurgie de la cATaracte au Laser Femtoseconde

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: Cataract surgery with Phacoemulsification
* Device: Femtosecond laser-assisted cataract surgery


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phaco<br>Cataract surgery by phacoemulsification | Procedure: Cataract surgery with Phacoemulsification<br>* 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.<br>|
| Experimental: Femto<br>Corneal incision, anterior capsulorhexis and lens fragmentation by femtosecond laser | Device: Femtosecond laser-assisted cataract surgery<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Cost/effectiveness ratio defined as cost per incremental therapeutic success. | 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°. | 3 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life evaluation using Visual Function 14 questionnaire | Before surgery (From day -8 to day -1) and months 1, 3 and 12 after surgery | 
| Learning curve of the femtosecond laser-assisted cataract surgery |  | End of research (Month 12) | 
| Overall costs of cataract surgery in both arms from the hospital perspective |  | End of research (Month 12) | 
| Incremental cost - Utility ratio defined as incremental Cost/QALY (Quality Adjusted Life Year) for healthcare insurance in both arms |  | 12 months after inclusion | 
| No severe intraoperative or postoperative complications |  | 3 months after inclusion | 
| Best Corrected Visual Acuity of 0 LogMAR |  | 3 months after inclusion | 
| Refractive error inferior or equal to 0.75 diopter |  | 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° |  | 3 months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract surgery, femtosecond laser cataract surgery, phacoemulsification, Cost-Benefit Analysis, Cost Effectiveness, Hospital Costs