Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery
NCT ID: NCT01982006
Last Updated: 2018-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
920 participants
INTERVENTIONAL
2013-10-09
2016-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Phaco
Cataract surgery by phacoemulsification
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.
Femto
Corneal incision, anterior capsulorhexis and lens fragmentation by femtosecond laser
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* French healthcare insurance beneficiary
Exclusion Criteria
* 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
22 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Cédric SCHWEITZER, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
BENARD Antoine, MD
Role: STUDY_CHAIR
University Hospital Bordeaux, France
Locations
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CHU de Bordeaux
Bordeaux, , France
CHU de Brest
Brest, , France
Hospices Civils de Lyon
Lyon, , France
Hôpital Cochin
Paris, , France
CHU de Tours
Tours, , France
Countries
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References
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Abraham AG, Condon NG, West Gower E. The new epidemiology of cataract. Ophthalmol Clin North Am. 2006 Dec;19(4):415-25. doi: 10.1016/j.ohc.2006.07.008.
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.
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.
Hovding 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. doi: 10.1111/j.1755-3768.1994.tb07188.x.
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.
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. doi: 10.1136/bjo.81.2.102.
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. doi: 10.1016/s0886-3350(13)80499-3.
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. doi: 10.1136/bjo.80.8.689.
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.
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.
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.
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.
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. No abstract available.
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. doi: 10.1016/j.jcrs.2004.02.072.
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.
Benard A, Sitta R, Brezin AP, Cochener B, Monnet D, Denis P, Pisella PJ, Hayes N, Schweitzer C; FEMCAT Study Group. Cost Utility and Value of Information Analysis of Femtosecond Laser-Assisted Cataract Surgery. JAMA Ophthalmol. 2023 Jul 1;141(7):625-629. doi: 10.1001/jamaophthalmol.2023.1716.
Schweitzer C, Brezin A, Cochener B, Monnet D, Germain C, Roseng S, Sitta R, Maillard A, Hayes N, Denis P, Pisella PJ, Benard A; FEMCAT study group. Femtosecond laser-assisted versus phacoemulsification cataract surgery (FEMCAT): a multicentre participant-masked randomised superiority and cost-effectiveness trial. Lancet. 2020 Jan 18;395(10219):212-224. doi: 10.1016/S0140-6736(19)32481-X.
Schweitzer C, Hayes N, Brezin A, Cochener B, Denis P, Pisella PJ, Benard A; FEMCAT study group. Re: Abell et al.: Cost-effectiveness of femtosecond laser-assisted cataract surgery versus phacoemulsification cataract surgery (Ophthalmology 2014;121:10-6). Ophthalmology. 2014 Oct;121(10):e53-4. doi: 10.1016/j.ophtha.2014.05.025. Epub 2014 Jun 26. No abstract available.
Other Identifiers
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CHUBX 2012/23
Identifier Type: -
Identifier Source: org_study_id
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