Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery

Cataract Clinical Trial

— FEMCAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982006
• Other study ID #: CHUBX 2012/23
• Status: Completed
• Phase: Phase 3
• Start date: October 9, 2013
• Est. completion date: December 15, 2016

Study information

• Verified date: October 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 920
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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.

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHU de Brest	Brest
France	Hospices Civils de Lyon	Lyon
France	Hôpital Cochin	Paris
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (15)

Abraham AG, Condon NG, West Gower E. The new epidemiology of cataract. Ophthalmol Clin North Am. 2006 Dec;19(4):415-25. Review. — View Citation

Chatoux O, Touboul D, Buestel C, Balcou P, Colin J. [Crystalline lens photodisruption using femtosecond laser: experimental study]. J Fr Ophtalmol. 2010 Sep;33(7):472-80. doi: 10.1016/j.jfo.2010.06.008. French. — View Citation

Friedman NJ, Palanker DV, Schuele G, Andersen D, Marcellino G, Seibel BS, Batlle J, Feliz R, Talamo JH, Blumenkranz MS, Culbertson WW. Femtosecond laser capsulotomy. J Cataract Refract Surg. 2011 Jul;37(7):1189-98. doi: 10.1016/j.jcrs.2011.04.022. Erratum in: J Cataract Refract Surg. 2011 Sep;37(9):1742. — View Citation

Høvding G, Natvik C, Sletteberg O. The refractive error after implantation of a posterior chamber intraocular lens. The accuracy of IOL power calculation in a hospital practice. Acta Ophthalmol (Copenh). 1994 Oct;72(5):612-6. — View Citation

Lamoureux EL, Fenwick E, Pesudovs K, Tan D. The impact of cataract surgery on quality of life. Curr Opin Ophthalmol. 2011 Jan;22(1):19-27. doi: 10.1097/ICU.0b013e3283414284. Review. — View Citation

Masket S, Sarayba M, Ignacio T, Fram N. Femtosecond laser-assisted cataract incisions: architectural stability and reproducibility. J Cataract Refract Surg. 2010 Jun;36(6):1048-9. doi: 10.1016/j.jcrs.2010.03.027. — View Citation

Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009 Dec;25(12):1053-60. doi: 10.3928/1081597X-20091117-04. — View Citation

Norrby S. Sources of error in intraocular lens power calculation. J Cataract Refract Surg. 2008 Mar;34(3):368-76. doi: 10.1016/j.jcrs.2007.10.031. — View Citation

Norregaard JC, Thoning H, Andersen TF, Bernth-Petersen P, Javitt JC, Anderson GF. Risk of retinal detachment following cataract extraction: results from the International Cataract Surgery Outcomes Study. Br J Ophthalmol. 1996 Aug;80(8):689-93. — View Citation

Norregaard JC, Thoning H, Bernth-Petersen P, Andersen TF, Javitt JC, Anderson GF. Risk of endophthalmitis after cataract extraction: results from the International Cataract Surgery Outcomes study. Br J Ophthalmol. 1997 Feb;81(2):102-6. — View Citation

Palanker DV, Blumenkranz MS, Andersen D, Wiltberger M, Marcellino G, Gooding P, Angeley D, Schuele G, Woodley B, Simoneau M, Friedman NJ, Seibel B, Batlle J, Feliz R, Talamo J, Culbertson W. Femtosecond laser-assisted cataract surgery with integrated optical coherence tomography. Sci Transl Med. 2010 Nov 17;2(58):58ra85. doi: 10.1126/scitranslmed.3001305. — View Citation

Powell SK, Olson RJ. Incidence of retinal detachment after cataract surgery and neodymium: YAG laser capsulotomy. J Cataract Refract Surg. 1995 Mar;21(2):132-5. — View Citation

Qatarneh D, Mathew RG, Palmer S, Bunce C, Tuft S. The economic cost of posterior capsule tear at cataract surgery. Br J Ophthalmol. 2012 Jan;96(1):114-7. doi: 10.1136/bjo.2010.200832. Epub 2011 Mar 1. — View Citation

Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14. — View Citation

Taketani F, Matuura T, Yukawa E, Hara Y. Influence of intraocular lens tilt and decentration on wavefront aberrations. J Cataract Refract Surg. 2004 Oct;30(10):2158-62. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Learning curve of the femtosecond laser-assisted cataract surgery		End of research (Month 12)
Secondary	Overall costs of cataract surgery in both arms from the hospital perspective		End of research (Month 12)
Secondary	Incremental cost - Utility ratio defined as incremental Cost/QALY (Quality Adjusted Life Year) for healthcare insurance in both arms		12 months after inclusion
Secondary	No severe intraoperative or postoperative complications		3 months after inclusion
Secondary	Best Corrected Visual Acuity of 0 LogMAR		3 months after inclusion
Secondary	Refractive error inferior or equal to 0.75 diopter		3 months after inclusion
Secondary	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