Clinical trial NCT01982006: Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery
Official title: Impact Médico-Economique de la Chirurgie de la cATaracte au Laser Femtoseconde
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: cataract surgery
femtosecond laser cataract surgery
phacoemulsification
Cost-Benefit Analysis
Cost Effectiveness
Hospital Costs
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 920
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incremental Cost/effectiveness ratio defined as cost per incremental therapeutic success.
timeFrame: 3 months after inclusion
Secondary outcomes:
measure: Quality of life
timeFrame: Before surgery (From day -8 to day -1) and months 1, 3 and 12 after surgery
measure: Learning curve of the femtosecond laser-assisted cataract surgery
timeFrame: End of research (Month 12)
measure: Overall costs of cataract surgery in both arms from the hospital perspective
timeFrame: End of research (Month 12)
measure: Incremental cost - Utility ratio defined as incremental Cost/QALY (Quality Adjusted Life Year) for healthcare insurance in both arms
timeFrame: 12 months after inclusion
measure: No severe intraoperative or postoperative complications
timeFrame: 3 months after inclusion
measure: Best Corrected Visual Acuity of 0 LogMAR
timeFrame: 3 months after inclusion
measure: Refractive error inferior or equal to 0.75 diopter
timeFrame: 3 months after inclusion
measure: Corneal surgically-induced astigmatism inferior or equal to 0.5 diopter and a postoperative change of astigmatism axis inferior or equal to 20°
timeFrame: 3 months after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHU de Brest
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Paris
country: France
facility: Hôpital Cochin
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: University Hospital Bordeaux, France
name: Cédric SCHWEITZER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bordeaux, France
name: BENARD Antoine, MD
role: STUDY_CHAIR
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