Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study
Identifieur interne : 000E67 ( Main/Exploration ); précédent : 000E66; suivant : 000E68Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study
Auteurs : Peter Heiner [Australie] ; Edoardo Ligabue [Italie] ; Alex Fan [Hong Kong] ; Dennis Lam [Hong Kong]Source :
- Clinical Ophthalmology (Auckland, N.Z.) [ 1177-5467 ] ; 2014.
Abstract
To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL) (enVista® MX60; Bausch and Lomb Incorporated, Rochester, NY, USA) following implantation to correct aphakia subsequent to extracapsular cataract extraction in adults.
This was an open-label, non-interventional, observational study conducted in 19 university and private-practice settings in Europe and the Asia-Pacific region to investigate clinical outcomes of the MX60 IOL in standard practice. Eligible subjects were at least 18 years of age and had undergone standard phacoemulsification and extracapsular cataract extraction with implantation of the MX60 IOL. The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure.
In this multicenter study, pooled data of 255 eyes were collected and analyzed. Excellent visual and refractive outcomes and stability were demonstrated. At postoperative visit 4 (61–180 days postoperative), 62.2% of subjects achieved a Snellen best-corrected distance visual acuity (CDVA) of 20/20 (decimal 1.00), and 97.8% of subjects achieved a CDVA of 20/40 (decimal 0.50) or better. One eye (1.0%) underwent neodymium:yttrium aluminum garnet capsulotomy at 12 months post-procedure. No glistenings of any grade were reported for any subject at any visit. Adverse events were infrequent and were consistent with incidences generally reported with cataract surgery.
This study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice. Favorable clinical outcomes included outstanding visual and refractive outcomes and stability. No glistenings were reported at any postoperative visit.
Url:
DOI: 10.2147/OPTH.S56135
PubMed: 24729678
PubMed Central: 3974695
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream Pmc, to step Corpus: 001C41
- to stream Pmc, to step Curation: 001C41
- to stream Pmc, to step Checkpoint: 000972
- to stream Ncbi, to step Merge: 002E73
- to stream Ncbi, to step Curation: 002E73
- to stream Ncbi, to step Checkpoint: 002E73
- to stream Main, to step Merge: 000E66
- to stream Main, to step Curation: 000E67
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study</title><author><name sortKey="Heiner, Peter" sort="Heiner, Peter" uniqKey="Heiner P" first="Peter" last="Heiner">Peter Heiner</name><affiliation wicri:level="1"><nlm:aff id="af1-opth-8-629">Vision Eye Institute, Southport, QLD, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Vision Eye Institute, Southport, QLD</wicri:regionArea><wicri:noRegion>QLD</wicri:noRegion></affiliation></author><author><name sortKey="Ligabue, Edoardo" sort="Ligabue, Edoardo" uniqKey="Ligabue E" first="Edoardo" last="Ligabue">Edoardo Ligabue</name><affiliation wicri:level="1"><nlm:aff id="af2-opth-8-629">Ophthalmic Center, San Siro Clinic, Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Ophthalmic Center, San Siro Clinic, Milan</wicri:regionArea><wicri:noRegion>Milan</wicri:noRegion></affiliation></author><author><name sortKey="Fan, Alex" sort="Fan, Alex" uniqKey="Fan A" first="Alex" last="Fan">Alex Fan</name><affiliation wicri:level="4"><nlm:aff id="af3-opth-8-629">Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong</nlm:aff><country xml:lang="fr">Hong Kong</country><wicri:regionArea>Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories</wicri:regionArea><orgName type="university">Université chinoise de Hong Kong</orgName><placeName><settlement type="city">Sha Tin</settlement></placeName></affiliation></author><author><name sortKey="Lam, Dennis" sort="Lam, Dennis" uniqKey="Lam D" first="Dennis" last="Lam">Dennis Lam</name><affiliation wicri:level="4"><nlm:aff id="af3-opth-8-629">Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong</nlm:aff><country xml:lang="fr">Hong Kong</country><wicri:regionArea>Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories</wicri:regionArea><orgName type="university">Université chinoise de Hong Kong</orgName><placeName><settlement type="city">Sha Tin</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24729678</idno><idno type="pmc">3974695</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3974695</idno><idno type="RBID">PMC:3974695</idno><idno type="doi">10.2147/OPTH.S56135</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">001C41</idno><idno type="wicri:Area/Pmc/Curation">001C41</idno><idno type="wicri:Area/Pmc/Checkpoint">000972</idno><idno type="wicri:Area/Ncbi/Merge">002E73</idno><idno type="wicri:Area/Ncbi/Curation">002E73</idno><idno type="wicri:Area/Ncbi/Checkpoint">002E73</idno><idno type="wicri:doubleKey">1177-5467:2014:Heiner P:safety:and:effectiveness</idno><idno type="wicri:Area/Main/Merge">000E66</idno><idno type="wicri:Area/Main/Curation">000E67</idno><idno type="wicri:Area/Main/Exploration">000E67</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study</title><author><name sortKey="Heiner, Peter" sort="Heiner, Peter" uniqKey="Heiner P" first="Peter" last="Heiner">Peter Heiner</name><affiliation wicri:level="1"><nlm:aff id="af1-opth-8-629">Vision Eye Institute, Southport, QLD, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Vision Eye Institute, Southport, QLD</wicri:regionArea><wicri:noRegion>QLD</wicri:noRegion></affiliation></author><author><name sortKey="Ligabue, Edoardo" sort="Ligabue, Edoardo" uniqKey="Ligabue E" first="Edoardo" last="Ligabue">Edoardo Ligabue</name><affiliation wicri:level="1"><nlm:aff id="af2-opth-8-629">Ophthalmic Center, San Siro Clinic, Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Ophthalmic Center, San Siro Clinic, Milan</wicri:regionArea><wicri:noRegion>Milan</wicri:noRegion></affiliation></author><author><name sortKey="Fan, Alex" sort="Fan, Alex" uniqKey="Fan A" first="Alex" last="Fan">Alex Fan</name><affiliation wicri:level="4"><nlm:aff id="af3-opth-8-629">Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong</nlm:aff><country xml:lang="fr">Hong Kong</country><wicri:regionArea>Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories</wicri:regionArea><orgName type="university">Université chinoise de Hong Kong</orgName><placeName><settlement type="city">Sha Tin</settlement></placeName></affiliation></author><author><name sortKey="Lam, Dennis" sort="Lam, Dennis" uniqKey="Lam D" first="Dennis" last="Lam">Dennis Lam</name><affiliation wicri:level="4"><nlm:aff id="af3-opth-8-629">Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong</nlm:aff><country xml:lang="fr">Hong Kong</country><wicri:regionArea>Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories</wicri:regionArea><orgName type="university">Université chinoise de Hong Kong</orgName><placeName><settlement type="city">Sha Tin</settlement></placeName></affiliation></author></analytic><series><title level="j">Clinical Ophthalmology (Auckland, N.Z.)</title><idno type="ISSN">1177-5467</idno><idno type="eISSN">1177-5483</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p>To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL) (enVista® MX60; Bausch and Lomb Incorporated, Rochester, NY, USA) following implantation to correct aphakia subsequent to extracapsular cataract extraction in adults.</p></sec><sec><title>Subjects and methods</title><p>This was an open-label, non-interventional, observational study conducted in 19 university and private-practice settings in Europe and the Asia-Pacific region to investigate clinical outcomes of the MX60 IOL in standard practice. Eligible subjects were at least 18 years of age and had undergone standard phacoemulsification and extracapsular cataract extraction with implantation of the MX60 IOL. The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure.</p></sec><sec><title>Results</title><p>In this multicenter study, pooled data of 255 eyes were collected and analyzed. Excellent visual and refractive outcomes and stability were demonstrated. At postoperative visit 4 (61–180 days postoperative), 62.2% of subjects achieved a Snellen best-corrected distance visual acuity (CDVA) of 20/20 (decimal 1.00), and 97.8% of subjects achieved a CDVA of 20/40 (decimal 0.50) or better. One eye (1.0%) underwent neodymium:yttrium aluminum garnet capsulotomy at 12 months post-procedure. No glistenings of any grade were reported for any subject at any visit. Adverse events were infrequent and were consistent with incidences generally reported with cataract surgery.</p></sec><sec><title>Conclusion</title><p>This study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice. Favorable clinical outcomes included outstanding visual and refractive outcomes and stability. No glistenings were reported at any postoperative visit.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Steinert, Rf" uniqKey="Steinert R">RF Steinert</name></author><author><name sortKey="Puliafito, Ca" uniqKey="Puliafito C">CA Puliafito</name></author><author><name sortKey="Kumar, Sr" uniqKey="Kumar S">SR Kumar</name></author><author><name sortKey="Dudak, Sd" uniqKey="Dudak S">SD Dudak</name></author><author><name sortKey="Patel, S" uniqKey="Patel S">S Patel</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rickman Barger, L" uniqKey="Rickman Barger L">L Rickman-Barger</name></author><author><name sortKey="Florine, Cw" uniqKey="Florine C">CW Florine</name></author><author><name sortKey="Larson, Rs" uniqKey="Larson R">RS Larson</name></author><author><name sortKey="Lindstrom, Rl" uniqKey="Lindstrom R">RL Lindstrom</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Newland, Tj" uniqKey="Newland T">TJ Newland</name></author><author><name sortKey="Mcdermott, Ml" uniqKey="Mcdermott M">ML McDermott</name></author><author><name sortKey="Eliott, D" uniqKey="Eliott D">D Eliott</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Holweger, Rr" uniqKey="Holweger R">RR Holweger</name></author><author><name sortKey="Marefat, B" uniqKey="Marefat B">B Marefat</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Werner, L" uniqKey="Werner L">L Werner</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Christiansen, G" uniqKey="Christiansen G">G Christiansen</name></author><author><name sortKey="Durcan, Ej" uniqKey="Durcan E">EJ Durcan</name></author><author><name sortKey="Olson, Rj" uniqKey="Olson R">RJ Olson</name></author><author><name sortKey="Christiansen, K" uniqKey="Christiansen K">K Christiansen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Packer, M" uniqKey="Packer M">M Packer</name></author><author><name sortKey="Fry, L" uniqKey="Fry L">L Fry</name></author><author><name sortKey="Lavery, Kt" uniqKey="Lavery K">KT Lavery</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Dixon, Jr" uniqKey="Dixon J">JR Dixon</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Mentak, K" uniqKey="Mentak K">K Mentak</name></author><author><name sortKey="Goldberg, E" uniqKey="Goldberg E">E Goldberg</name></author><author><name sortKey="El Achchabi, A" uniqKey="El Achchabi A">A El-Achchabi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Eom, Y" uniqKey="Eom Y">Y Eom</name></author><author><name sortKey="Lee, Js" uniqKey="Lee J">JS Lee</name></author><author><name sortKey="Rhim, Jw" uniqKey="Rhim J">JW Rhim</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Caporossi, A" uniqKey="Caporossi A">A Caporossi</name></author><author><name sortKey="Martone, G" uniqKey="Martone G">G Martone</name></author><author><name sortKey="Casprini, F" uniqKey="Casprini F">F Casprini</name></author><author><name sortKey="Rapisarda, L" uniqKey="Rapisarda L">L Rapisarda</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Pepose, Js" uniqKey="Pepose J">JS Pepose</name></author><author><name sortKey="Qazi, Ma" uniqKey="Qazi M">MA Qazi</name></author><author><name sortKey="Edwards, Kh" uniqKey="Edwards K">KH Edwards</name></author><author><name sortKey="Sanderson, Jp" uniqKey="Sanderson J">JP Sanderson</name></author><author><name sortKey="Sarver, Ej" uniqKey="Sarver E">EJ Sarver</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Santhiago, Mr" uniqKey="Santhiago M">MR Santhiago</name></author><author><name sortKey="Netto, Mv" uniqKey="Netto M">MV Netto</name></author><author><name sortKey="Barreto, J" uniqKey="Barreto J">J Barreto</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nixon, Dr" uniqKey="Nixon D">DR Nixon</name></author><author><name sortKey="Woodcock, Mg" uniqKey="Woodcock M">MG Woodcock</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Parulekar, Mv" uniqKey="Parulekar M">MV Parulekar</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Mckellar, Mj" uniqKey="Mckellar M">MJ McKellar</name></author><author><name sortKey="Elder, Mj" uniqKey="Elder M">MJ Elder</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ram, J" uniqKey="Ram J">J Ram</name></author><author><name sortKey="Kaushik, S" uniqKey="Kaushik S">S Kaushik</name></author><author><name sortKey="Brar, Gs" uniqKey="Brar G">GS Brar</name></author><author><name sortKey="Gupta, A" uniqKey="Gupta A">A Gupta</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Biber, Jm" uniqKey="Biber J">JM Biber</name></author><author><name sortKey="Sandoval, Hp" uniqKey="Sandoval H">HP Sandoval</name></author><author><name sortKey="Trivedi, Rh" uniqKey="Trivedi R">RH Trivedi</name></author><author><name sortKey="Fernandez De Castro, Le" uniqKey="Fernandez De Castro L">LE Fernández de Castro</name></author><author><name sortKey="French, Jw" uniqKey="French J">JW French</name></author><author><name sortKey="Solomon, Kd" uniqKey="Solomon K">KD Solomon</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Apple, Dj" uniqKey="Apple D">DJ Apple</name></author><author><name sortKey="Peng, Q" uniqKey="Peng Q">Q Peng</name></author><author><name sortKey="Visessook, N" uniqKey="Visessook N">N Visessook</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tetz, Mr" uniqKey="Tetz M">MR Tetz</name></author><author><name sortKey="Werner, L" uniqKey="Werner L">L Werner</name></author><author><name sortKey="Schwahn Bendig, S" uniqKey="Schwahn Bendig S">S Schwahn-Bendig</name></author><author><name sortKey="Batlle, Jf" uniqKey="Batlle J">JF Batlle</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Dhaliwal, Dk" uniqKey="Dhaliwal D">DK Dhaliwal</name></author><author><name sortKey="Mamalis, N" uniqKey="Mamalis N">N Mamalis</name></author><author><name sortKey="Olson, Rj" uniqKey="Olson R">RJ Olson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gunenc, U" uniqKey="Gunenc U">U Gunenc</name></author><author><name sortKey="Oner, Fh" uniqKey="Oner F">FH Oner</name></author><author><name sortKey="Tongal, S" uniqKey="Tongal S">S Tongal</name></author><author><name sortKey="Ferliel, M" uniqKey="Ferliel M">M Ferliel</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tognetto, D" uniqKey="Tognetto D">D Tognetto</name></author><author><name sortKey="Toto, L" uniqKey="Toto L">L Toto</name></author><author><name sortKey="Sanguinetti, G" uniqKey="Sanguinetti G">G Sanguinetti</name></author><author><name sortKey="Ravalico, G" uniqKey="Ravalico G">G Ravalico</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Behndig, A" uniqKey="Behndig A">A Behndig</name></author><author><name sortKey="Monestam, E" uniqKey="Monestam E">E Monestam</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Colin, J" uniqKey="Colin J">J Colin</name></author><author><name sortKey="Praud, D" uniqKey="Praud D">D Praud</name></author><author><name sortKey="Touboul, D" uniqKey="Touboul D">D Touboul</name></author><author><name sortKey="Schweitzer, C" uniqKey="Schweitzer C">C Schweitzer</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Packer, M" uniqKey="Packer M">M Packer</name></author><author><name sortKey="Fry, L" uniqKey="Fry L">L Fry</name></author><author><name sortKey="Lavery, Kt" uniqKey="Lavery K">KT Lavery</name></author><author><name sortKey="Lehmann, R" uniqKey="Lehmann R">R Lehmann</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Australie</li><li>Hong Kong</li><li>Italie</li></country><settlement><li>Sha Tin</li></settlement><orgName><li>Université chinoise de Hong Kong</li></orgName></list><tree><country name="Australie"><noRegion><name sortKey="Heiner, Peter" sort="Heiner, Peter" uniqKey="Heiner P" first="Peter" last="Heiner">Peter Heiner</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Ligabue, Edoardo" sort="Ligabue, Edoardo" uniqKey="Ligabue E" first="Edoardo" last="Ligabue">Edoardo Ligabue</name></noRegion></country><country name="Hong Kong"><noRegion><name sortKey="Fan, Alex" sort="Fan, Alex" uniqKey="Fan A" first="Alex" last="Fan">Alex Fan</name></noRegion><name sortKey="Lam, Dennis" sort="Lam, Dennis" uniqKey="Lam D" first="Dennis" last="Lam">Dennis Lam</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Ticri/CIDE/explor/HapticV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000E67 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 000E67 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Ticri/CIDE
|area= HapticV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= PMC:3974695
|texte= Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:24729678" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a HapticV1
| This area was generated with Dilib version V0.6.23. |  |