Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study.
Identifieur interne : 001795 ( PubMed/Corpus ); précédent : 001794; suivant : 001796Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study.
Auteurs : K A Becker ; M. Martin ; T M Rabsilber ; B B Entz ; A J Reuland ; G U AuffarthSource :
- The British journal of ophthalmology [ 0007-1161 ] ; 2006.
English descriptors
- KwdEn :
- Acrylic Resins, Aged, Aged, 80 and over, Biocompatible Materials, Cataract (etiology), Endothelial Cells (pathology), Female, Follow-Up Studies, Humans, Laser Therapy, Lens Capsule, Crystalline (pathology), Lens Capsule, Crystalline (surgery), Lenses, Intraocular, Male, Materials Testing, Middle Aged, Postoperative Complications, Prospective Studies, Prosthesis Design, Recurrence.
- MESH :
- chemical : Acrylic Resins, Biocompatible Materials.
- etiology : Cataract.
- pathology : Endothelial Cells, Lens Capsule, Crystalline.
- surgery : Lens Capsule, Crystalline.
- Aged, Aged, 80 and over, Female, Follow-Up Studies, Humans, Laser Therapy, Lenses, Intraocular, Male, Materials Testing, Middle Aged, Postoperative Complications, Prospective Studies, Prosthesis Design, Recurrence.
Abstract
Owing to the improvement of modern intraocular lenses (IOLs) in terms of design and material, posterior capsule opacification (PCO) usually takes 2-3 years to develop. Thus, long term clinical evaluation of new implants is important.
DOI: 10.1136/bjo.2006.092437
PubMed: 16687454
Links to Exploration step
pubmed:16687454Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study.</title><author><name sortKey="Becker, K A" sort="Becker, K A" uniqKey="Becker K" first="K A" last="Becker">K A Becker</name><affiliation><nlm:affiliation>Heidelberg IOL and Refractive Surgery Research Group, Department of Ophthalmology, Ruprecht-Karls-University of Heidelberg, Heidelberg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Martin, M" sort="Martin, M" uniqKey="Martin M" first="M" last="Martin">M. Martin</name></author><author><name sortKey="Rabsilber, T M" sort="Rabsilber, T M" uniqKey="Rabsilber T" first="T M" last="Rabsilber">T M Rabsilber</name></author><author><name sortKey="Entz, B B" sort="Entz, B B" uniqKey="Entz B" first="B B" last="Entz">B B Entz</name></author><author><name sortKey="Reuland, A J" sort="Reuland, A J" uniqKey="Reuland A" first="A J" last="Reuland">A J Reuland</name></author><author><name sortKey="Auffarth, G U" sort="Auffarth, G U" uniqKey="Auffarth G" first="G U" last="Auffarth">G U Auffarth</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2006">2006</date><idno type="doi">10.1136/bjo.2006.092437</idno><idno type="RBID">pubmed:16687454</idno><idno type="pmid">16687454</idno><idno type="wicri:Area/PubMed/Corpus">001795</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study.</title><author><name sortKey="Becker, K A" sort="Becker, K A" uniqKey="Becker K" first="K A" last="Becker">K A Becker</name><affiliation><nlm:affiliation>Heidelberg IOL and Refractive Surgery Research Group, Department of Ophthalmology, Ruprecht-Karls-University of Heidelberg, Heidelberg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Martin, M" sort="Martin, M" uniqKey="Martin M" first="M" last="Martin">M. Martin</name></author><author><name sortKey="Rabsilber, T M" sort="Rabsilber, T M" uniqKey="Rabsilber T" first="T M" last="Rabsilber">T M Rabsilber</name></author><author><name sortKey="Entz, B B" sort="Entz, B B" uniqKey="Entz B" first="B B" last="Entz">B B Entz</name></author><author><name sortKey="Reuland, A J" sort="Reuland, A J" uniqKey="Reuland A" first="A J" last="Reuland">A J Reuland</name></author><author><name sortKey="Auffarth, G U" sort="Auffarth, G U" uniqKey="Auffarth G" first="G U" last="Auffarth">G U Auffarth</name></author></analytic><series><title level="j">The British journal of ophthalmology</title><idno type="ISSN">0007-1161</idno><imprint><date when="2006" type="published">2006</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acrylic Resins</term><term>Aged</term><term>Aged, 80 and over</term><term>Biocompatible Materials</term><term>Cataract (etiology)</term><term>Endothelial Cells (pathology)</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Laser Therapy</term><term>Lens Capsule, Crystalline (pathology)</term><term>Lens Capsule, Crystalline (surgery)</term><term>Lenses, Intraocular</term><term>Male</term><term>Materials Testing</term><term>Middle Aged</term><term>Postoperative Complications</term><term>Prospective Studies</term><term>Prosthesis Design</term><term>Recurrence</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Acrylic Resins</term><term>Biocompatible Materials</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Cataract</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Endothelial Cells</term><term>Lens Capsule, Crystalline</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Lens Capsule, Crystalline</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Aged, 80 and over</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Laser Therapy</term><term>Lenses, Intraocular</term><term>Male</term><term>Materials Testing</term><term>Middle Aged</term><term>Postoperative Complications</term><term>Prospective Studies</term><term>Prosthesis Design</term><term>Recurrence</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Owing to the improvement of modern intraocular lenses (IOLs) in terms of design and material, posterior capsule opacification (PCO) usually takes 2-3 years to develop. Thus, long term clinical evaluation of new implants is important.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">16687454</PMID><DateCreated><Year>2006</Year><Month>07</Month><Day>20</Day></DateCreated><DateCompleted><Year>2006</Year><Month>08</Month><Day>16</Day></DateCompleted><DateRevised><Year>2014</Year><Month>09</Month><Day>09</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Print">0007-1161</ISSN><JournalIssue CitedMedium="Print"><Volume>90</Volume><Issue>8</Issue><PubDate><Year>2006</Year><Month>Aug</Month></PubDate></JournalIssue><Title>The British journal of ophthalmology</Title><ISOAbbreviation>Br J Ophthalmol</ISOAbbreviation></Journal><ArticleTitle>Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study.</ArticleTitle><Pagination><MedlinePgn>971-4</MedlinePgn></Pagination><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Owing to the improvement of modern intraocular lenses (IOLs) in terms of design and material, posterior capsule opacification (PCO) usually takes 2-3 years to develop. Thus, long term clinical evaluation of new implants is important.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">As part of a prospective, non-randomised FDA trial, the Rayner Centerflex, a foldable hydrophilic acrylic, single piece IOL was implanted in one eye of 83 patients (mean age 73.5 (SD 7.0) years). Over 3 years postoperatively, a standardised FDA protocol concerning IOL safety and efficacy was followed including evaluation of spherical equivalent (SE), best corrected distance visual acuity (BCDVA), endothelial cell count (ECC), flare meter values, PCO development, and anterior capsule shrinkage.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Postoperatively, mean SE was stable ranging between -0.3D and 0.17D. After 1-2 months, all patients achieved a BCDVA of 20/40 or better. At 3-6 months postoperatively, mean ECC decreased from 2612 (SD 346) cells/mm2 to 2380 (316) cells/mm2. Mean PCO score for the entire optic increased from 0.20 (0.20) months (3-6 months postoperatively) to 0.87 (0.57) resulting in a Nd:YAG rate of 29.41% after 3 years. No anterior capsule shrinkage was found.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">The Centerflex showed excellent functional results, low values for endothelial cell loss and inflammatory signs, and no anterior capsule shrinkage. PCO formation was higher compared to other IOLs, which could be explained by the incomplete sharp edge at the optic-haptic junctions representing an "Achilles' heel" for cell ingrowth.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Becker</LastName><ForeName>K A</ForeName><Initials>KA</Initials><AffiliationInfo><Affiliation>Heidelberg IOL and Refractive Surgery Research Group, Department of Ophthalmology, Ruprecht-Karls-University of Heidelberg, Heidelberg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Martin</LastName><ForeName>M</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Rabsilber</LastName><ForeName>T M</ForeName><Initials>TM</Initials></Author><Author ValidYN="Y"><LastName>Entz</LastName><ForeName>B B</ForeName><Initials>BB</Initials></Author><Author ValidYN="Y"><LastName>Reuland</LastName><ForeName>A J</ForeName><Initials>AJ</Initials></Author><Author ValidYN="Y"><LastName>Auffarth</LastName><ForeName>G U</ForeName><Initials>GU</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2006</Year><Month>05</Month><Day>10</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Br J Ophthalmol</MedlineTA><NlmUniqueID>0421041</NlmUniqueID><ISSNLinking>0007-1161</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000180">Acrylic Resins</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001672">Biocompatible Materials</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Ophthalmologe. 2005 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Materials</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D002386">Cataract</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000209">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D042783">Endothelial Cells</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000473">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005500">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D053685">Laser Therapy</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007903">Lens Capsule, Crystalline</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000473">pathology</QualifierName><QualifierName MajorTopicYN="N" UI="Q000601">surgery</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D007910">Lenses, Intraocular</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008422">Materials Testing</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011183">Postoperative Complications</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011446">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011474">Prosthesis Design</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012008">Recurrence</DescriptorName></MeshHeading></MeshHeadingList><OtherID 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