Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery

NCT01982006 | Completed Phase 3

• 1 other identifier: CHUBX 2012/23
• Study Type: interventional
• Target: 920
• Locations: 1 country
• Sites: 5

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.

Conditions

Cataract

Keywords

cataract surgery; femtosecond laser cataract surgery; phacoemulsification; Cost-Benefit Analysis; Cost Effectiveness; Hospital Costs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Quality of life

  Before surgery (From day -8 to day -1) and months 1, 3 and 12 after surgery

• Learning curve of the femtosecond laser-assisted cataract surgery

  End of research (Month 12)

• 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

Study Arms (2)

Phaco

ACTIVE COMPARATOR

Cataract surgery by phacoemulsification

Procedure: Cataract surgery with Phacoemulsification

Femto

EXPERIMENTAL

Corneal incision, anterior capsulorhexis and lens fragmentation by femtosecond laser

Device: Femtosecond laser-assisted cataract surgery

Interventions

Cataract surgery with Phacoemulsification PROCEDURE

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.

Phaco

Femtosecond laser-assisted cataract surgery DEVICE

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

Femto

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataract with impaired visual acuity (\> or equal +0.3 LogMAR) or with cataract-related visual symptoms (Halos, Monocular diplopia, glare)
• French healthcare insurance beneficiary

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (5)

CHU de Bordeaux

Bordeaux, 33000, France

Location

CHU de Brest

Brest, 29609, France

Location

Hospices Civils de Lyon

Lyon, 69317, France

Location

Hôpital Cochin

Paris, 75679, France

Location

CHU de Tours

Tours, 37044, France

Location

Related Publications (18)

• 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.

  PMID: 17067897 BACKGROUND

• 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.

  PMID: 15640920 BACKGROUND

• 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.

  PMID: 21088580 BACKGROUND

• 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.

  PMID: 7887161 BACKGROUND

• 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.

  PMID: 18299059 BACKGROUND

• 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.

  PMID: 9059242 BACKGROUND

• 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.

  PMID: 7791051 BACKGROUND

• 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.

  PMID: 8949710 BACKGROUND

• 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.

  PMID: 21362773 BACKGROUND

• 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.

  PMID: 20817344 BACKGROUND

• 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.

  PMID: 21700099 BACKGROUND

• 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.

  PMID: 21084720 BACKGROUND

• 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.

  PMID: 20494782 BACKGROUND

• 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.

  PMID: 15474830 BACKGROUND

• 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.

  PMID: 20000286 BACKGROUND

• 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.

  PMID: 37200037 DERIVED

• 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.

  PMID: 31954466 DERIVED

• 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.

  PMID: 24974812 DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction; Phacoemulsification

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Cédric SCHWEITZER, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

• BENARD Antoine, MD

  University Hospital Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: November 13, 2013
• Study Start: October 9, 2013
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: October 4, 2018

Record last verified: 2018-10

Locations

FR (5)