Impact Médico-Economique de la Chirurgie de la cATaracte au Laser Femtoseconde
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 920
- 试验地点
- 10
- 主要终点
- Incremental Cost/effectiveness ratio defined as cost per incremental therapeutic success.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract with impaired visual acuity (> or equal +0.3 LogMAR) or with cataract-related visual symptoms (Halos, Monocular diplopia, glare)
- •French healthcare insurance beneficiary
排除标准
- •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
研究组 & 干预措施
Phaco
Cataract surgery by phacoemulsification
干预措施: Cataract surgery with Phacoemulsification (Procedure)
Femto
Corneal incision, anterior capsulorhexis and lens fragmentation by femtosecond laser
干预措施: Femtosecond laser-assisted cataract surgery (Device)
结局指标
主要结局
Incremental Cost/effectiveness ratio defined as cost per incremental therapeutic success.
时间窗: 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°.
次要结局
- Learning curve of the femtosecond laser-assisted cataract surgery(End of research (Month 12))
- Quality of life(Before surgery (From day -8 to day -1) and months 1, 3 and 12 after surgery)
- 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)