Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery (FEMCAT)

University Hospital of Bordeaux

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Device: Femtosecond laser-assisted cataract surgery; Procedure: Cataract surgery with Phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT01982006

CHUBX 2012/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 920 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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920 participants in 2 patient groups

Phaco

Active Comparator group

Description:

Cataract surgery by phacoemulsification

Treatment:

Procedure: Cataract surgery with Phacoemulsification

Femto

Experimental group

Description:

Corneal incision, anterior capsulorhexis and lens fragmentation by femtosecond laser

Treatment:

Device: Femtosecond laser-assisted cataract surgery