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CataractPhase 3FEMCATNCT01982006

Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery

A Phase 3 study testing Cataract surgery with Phacoemulsification and Femtosecond laser-assisted cataract surgery in people with Cataract, run by University Hospital, Bordeaux at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Cataract
What is being tested?
Cataract surgery with Phacoemulsification and Femtosecond laser-assisted cataract surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
920 participants
Where
5 sitesFrance
Study dates
9 Oct 2013to 15 Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Pupil size lower than 6mm
  • Iris constriction
  • Iris synechiae
  • Preoperative zonular instability or crystalline lens subluxation
  • Obstructive Corneal scars
  • Obstructive pterygion
Show all 18Show fewer
  • 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 locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • CHU de Bordeaux

    Bordeaux, 33000

  • CHU de Brest

    Brest, 29609

  • Hospices Civils de Lyon

    Lyon, 69317

  • Hôpital Cochin

    Paris, 75679

  • CHU de Tours

    Tours, 37044

Other trials in France

About this study

Official title: Impact Médico-Economique de la Chirurgie de la cATaracte au Laser Femtoseconde

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.

Read the detailed 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.

Conditions
Cataract
Being tested
Cataract surgery with Phacoemulsification, Femtosecond laser-assisted cataract surgery
Keywords
cataract surgery, femtosecond laser cataract surgery, phacoemulsification, Cost-Benefit Analysis, Cost Effectiveness, Hospital Costs
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cataract surgery with PhacoemulsificationProcedure or surgery

    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 surgeryDevice

    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

Study groups in NCT01982006
Study groupRoleWhat they receive
PhacoActive comparatorCataract surgery by phacoemulsification
Receives: Procedure: Cataract surgery with Phacoemulsification
FemtoExperimentalCorneal incision, anterior capsulorhexis and lens fragmentation by femtosecond laser
Receives: Device: Femtosecond laser-assisted cataract surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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°.

    Measured: 3 months after inclusion

Secondary outcomes (8)

  1. Quality of life

    Quality of life evaluation using Visual Function 14 questionnaire

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

  2. Learning curve of the femtosecond laser-assisted cataract surgery

    Measured: End of research (Month 12)

  3. Overall costs of cataract surgery in both arms from the hospital perspective

    Measured: End of research (Month 12)

  4. Incremental cost - Utility ratio defined as incremental Cost/QALY (Quality Adjusted Life Year) for healthcare insurance in both arms

    Measured: 12 months after inclusion

  5. No severe intraoperative or postoperative complications

    Measured: 3 months after inclusion

  6. Best Corrected Visual Acuity of 0 LogMAR

    Measured: 3 months after inclusion

  7. Refractive error inferior or equal to 0.75 diopter

    Measured: 3 months after inclusion

  8. Corneal surgically-induced astigmatism inferior or equal to 0.5 diopter and a postoperative change of astigmatism axis inferior or equal to 20°

    Measured: 3 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2013 (estimated)
  2. Study start9 Oct 2013
  3. Primary completion15 Dec 2016
  4. Study completion15 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
920 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01982006
Sponsor's protocol ID
CHUBX 2012/23
Acronym
FEMCAT
Status last verified
Oct 2018
First submitted
21 Oct 2013
Last updated
4 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17067897

  • 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.

    PubMed 15640920

  • 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.

    PubMed 21088580

  • 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.

    PubMed 7887161

  • 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.

    PubMed 18299059

  • 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.

    PubMed 9059242

  • 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.

    PubMed 7791051

  • 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.

    PubMed 8949710

  • 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.

    PubMed 21362773

  • 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.

    PubMed 20817344

  • 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.

    PubMed 21700099

  • 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.

    PubMed 21084720

  • 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.

    PubMed 20494782

  • 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.

    PubMed 15474830

  • 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.

    PubMed 20000286

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cataract surgery with Phacoemulsification and Femtosecond laser-assisted cataract surgery in people with Cataract, run by University Hospital, Bordeaux at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incremental Cost/effectiveness ratio defined as cost per incremental therapeutic success. (time frame: 3 months after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01982006, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.

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