Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes
Identifieur interne : 001562 ( Istex/Corpus ); précédent : 001561; suivant : 001563Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes
Auteurs : John N. Norton ; Thomas Kohnen ; Robert B. Hackett ; Anil Patel ; Douglas D. KochSource :
- Journal of Cataract & Refractive Surgery [ 0886-3350 ] ; 1999.
Abstract
Purpose To evaluate the appropriate duration for conducting ocular biocompatibility studies with an intraocular lens (IOL) in the pseudophakic rabbit model.Setting Alcon Laboratories, Inc., Fort Worth, Texas, USA.Methods A single-piece biconvex poly(methyl methacrylate) (PMMA) IOL was implanted in the capsular bag of 18 eyes of New Zealand white rabbits; 8 eyes received sham surgeries. Rabbits were monitored clinically and then sacrificed 6 or 12 months after surgery for histopathological examination of ocular tissues.Results Biomicroscopic examination revealed mild ocular changes in all surgical eyes during the first 3 months postoperatively. After that, there was a high incidence of posterior synechias, flare, and posterior capsule opacification (PCO) in eyes with PMMA IOLs. Posterior synechias and flare scores remained mild to moderate throughout the study, whereas PCO severity increased over time. Similar findings were observed in sham eyes. In addition, several eyes with PMMA IOLs developed IOL dislocation, hyphema, iris bombe, and a fibrous membrane covering the IOL. No discernible differences in biomicroscopic scores were observed in eyes at 6 or 12 months. Intraocular pressures and morphology of the corneal endothelium were normal in both groups. Results from histopathological analysis of the ocular tissues were consistent with observations from the biomicroscopic examinations.Conclusion The results suggest that IOL implantation studies in the pseudophakic rabbit eye should be conducted for 3 or fewer months. Regulatory guidelines requiring longer ocular implantation studies should be revised to reflect the inherently rapid and extensive ocular response in the rabbit model.
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DOI: 10.1016/S0886-3350(99)00237-0
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes</title><author><name sortKey="Norton, John N" sort="Norton, John N" uniqKey="Norton J" first="John N" last="Norton">John N. Norton</name><affiliation><mods:affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</mods:affiliation></affiliation></author><author><name sortKey="Kohnen, Thomas" sort="Kohnen, Thomas" uniqKey="Kohnen T" first="Thomas" last="Kohnen">Thomas Kohnen</name><affiliation><mods:affiliation>Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA (Kohnen, Koch)</mods:affiliation></affiliation></author><author><name sortKey="Hackett, Robert B" sort="Hackett, Robert B" uniqKey="Hackett R" first="Robert B" last="Hackett">Robert B. Hackett</name><affiliation><mods:affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</mods:affiliation></affiliation></author><author><name sortKey="Patel, Anil" sort="Patel, Anil" uniqKey="Patel A" first="Anil" last="Patel">Anil Patel</name><affiliation><mods:affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</mods:affiliation></affiliation></author><author><name sortKey="Koch, Douglas D" sort="Koch, Douglas D" uniqKey="Koch D" first="Douglas D" last="Koch">Douglas D. Koch</name><affiliation><mods:affiliation>Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA (Kohnen, Koch)</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:99D1498B07B7AE8257262B133C5BCDFF485675E3</idno><date when="1999" year="1999">1999</date><idno type="doi">10.1016/S0886-3350(99)00237-0</idno><idno type="url">https://api.istex.fr/document/99D1498B07B7AE8257262B133C5BCDFF485675E3/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001562</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes</title><author><name sortKey="Norton, John N" sort="Norton, John N" uniqKey="Norton J" first="John N" last="Norton">John N. Norton</name><affiliation><mods:affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</mods:affiliation></affiliation></author><author><name sortKey="Kohnen, Thomas" sort="Kohnen, Thomas" uniqKey="Kohnen T" first="Thomas" last="Kohnen">Thomas Kohnen</name><affiliation><mods:affiliation>Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA (Kohnen, Koch)</mods:affiliation></affiliation></author><author><name sortKey="Hackett, Robert B" sort="Hackett, Robert B" uniqKey="Hackett R" first="Robert B" last="Hackett">Robert B. Hackett</name><affiliation><mods:affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</mods:affiliation></affiliation></author><author><name sortKey="Patel, Anil" sort="Patel, Anil" uniqKey="Patel A" first="Anil" last="Patel">Anil Patel</name><affiliation><mods:affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</mods:affiliation></affiliation></author><author><name sortKey="Koch, Douglas D" sort="Koch, Douglas D" uniqKey="Koch D" first="Douglas D" last="Koch">Douglas D. Koch</name><affiliation><mods:affiliation>Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA (Kohnen, Koch)</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Journal of Cataract & Refractive Surgery</title><title level="j" type="abbrev">JCRS</title><idno type="ISSN">0886-3350</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1999">1999</date><biblScope unit="volume">25</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1467">1467</biblScope><biblScope unit="page" to="1479">1479</biblScope></imprint><idno type="ISSN">0886-3350</idno></series><idno type="istex">99D1498B07B7AE8257262B133C5BCDFF485675E3</idno><idno type="DOI">10.1016/S0886-3350(99)00237-0</idno><idno type="PII">S0886-3350(99)00237-0</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0886-3350</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose To evaluate the appropriate duration for conducting ocular biocompatibility studies with an intraocular lens (IOL) in the pseudophakic rabbit model.Setting Alcon Laboratories, Inc., Fort Worth, Texas, USA.Methods A single-piece biconvex poly(methyl methacrylate) (PMMA) IOL was implanted in the capsular bag of 18 eyes of New Zealand white rabbits; 8 eyes received sham surgeries. Rabbits were monitored clinically and then sacrificed 6 or 12 months after surgery for histopathological examination of ocular tissues.Results Biomicroscopic examination revealed mild ocular changes in all surgical eyes during the first 3 months postoperatively. After that, there was a high incidence of posterior synechias, flare, and posterior capsule opacification (PCO) in eyes with PMMA IOLs. Posterior synechias and flare scores remained mild to moderate throughout the study, whereas PCO severity increased over time. Similar findings were observed in sham eyes. In addition, several eyes with PMMA IOLs developed IOL dislocation, hyphema, iris bombe, and a fibrous membrane covering the IOL. No discernible differences in biomicroscopic scores were observed in eyes at 6 or 12 months. Intraocular pressures and morphology of the corneal endothelium were normal in both groups. Results from histopathological analysis of the ocular tissues were consistent with observations from the biomicroscopic examinations.Conclusion The results suggest that IOL implantation studies in the pseudophakic rabbit eye should be conducted for 3 or fewer months. Regulatory guidelines requiring longer ocular implantation studies should be revised to reflect the inherently rapid and extensive ocular response in the rabbit model.</div></front></TEI><istex><corpusName>elsevier</corpusName><author><json:item><name>John N Norton DVM, PhD</name><affiliations><json:string>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</json:string></affiliations></json:item><json:item><name>Thomas Kohnen MD</name><affiliations><json:string>Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA (Kohnen, Koch)</json:string></affiliations></json:item><json:item><name>Robert B Hackett PhD</name><affiliations><json:string>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</json:string></affiliations></json:item><json:item><name>Anil Patel PhD</name><affiliations><json:string>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</json:string></affiliations></json:item><json:item><name>Douglas D Koch MD</name><affiliations><json:string>Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA (Kohnen, Koch)</json:string></affiliations></json:item></author><language><json:string>eng</json:string></language><abstract>Purpose To evaluate the appropriate duration for conducting ocular biocompatibility studies with an intraocular lens (IOL) in the pseudophakic rabbit model.Setting Alcon Laboratories, Inc., Fort Worth, Texas, USA.Methods A single-piece biconvex poly(methyl methacrylate) (PMMA) IOL was implanted in the capsular bag of 18 eyes of New Zealand white rabbits; 8 eyes received sham surgeries. Rabbits were monitored clinically and then sacrificed 6 or 12 months after surgery for histopathological examination of ocular tissues.Results Biomicroscopic examination revealed mild ocular changes in all surgical eyes during the first 3 months postoperatively. After that, there was a high incidence of posterior synechias, flare, and posterior capsule opacification (PCO) in eyes with PMMA IOLs. Posterior synechias and flare scores remained mild to moderate throughout the study, whereas PCO severity increased over time. Similar findings were observed in sham eyes. In addition, several eyes with PMMA IOLs developed IOL dislocation, hyphema, iris bombe, and a fibrous membrane covering the IOL. No discernible differences in biomicroscopic scores were observed in eyes at 6 or 12 months. Intraocular pressures and morphology of the corneal endothelium were normal in both groups. Results from histopathological analysis of the ocular tissues were consistent with observations from the biomicroscopic examinations.Conclusion The results suggest that IOL implantation studies in the pseudophakic rabbit eye should be conducted for 3 or fewer months. Regulatory guidelines requiring longer ocular implantation studies should be revised to reflect the inherently rapid and extensive ocular response in the rabbit model.</abstract><qualityIndicators><score>7.904</score><pdfVersion>1.2</pdfVersion><pdfPageSize>586 x 785 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>0</keywordCount><abstractCharCount>1710</abstractCharCount><pdfWordCount>5776</pdfWordCount><pdfCharCount>37747</pdfCharCount><pdfPageCount>13</pdfPageCount><abstractWordCount>242</abstractWordCount></qualityIndicators><title>Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes</title><pii><json:string>S0886-3350(99)00237-0</json:string></pii><genre><json:string>research-article</json:string></genre><host><volume>25</volume><pii><json:string>S0886-3350(00)X0007-7</json:string></pii><pages><last>1479</last><first>1467</first></pages><issn><json:string>0886-3350</json:string></issn><issue>11</issue><genre><json:string>Journal</json:string></genre><language><json:string>unknown</json:string></language><title>Journal of Cataract & Refractive Surgery</title><publicationDate>1999</publicationDate></host><categories><wos><json:string>OPHTHALMOLOGY</json:string><json:string>SURGERY</json:string></wos></categories><publicationDate>1999</publicationDate><copyrightDate>1999</copyrightDate><doi><json:string>10.1016/S0886-3350(99)00237-0</json:string></doi><id>99D1498B07B7AE8257262B133C5BCDFF485675E3</id><score>1</score><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/99D1498B07B7AE8257262B133C5BCDFF485675E3/fulltext/pdf</uri></json:item><json:item><original>true</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/99D1498B07B7AE8257262B133C5BCDFF485675E3/fulltext/txt</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/99D1498B07B7AE8257262B133C5BCDFF485675E3/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/99D1498B07B7AE8257262B133C5BCDFF485675E3/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>ELSEVIER</publisher><availability><p>ELSEVIER</p></availability><date>1999</date></publicationStmt><notesStmt><note>Conducted under Good Laboratory Principles (GLP) as set forth in the Code of Federal Regulations, Part 58, and supported in part by grants from the Deutsche Forschungsgemeinschaft (DFG-Ko 1595/1-1 and 1-2) (Dr. Kohnen) and Research to Prevent Blindness, New York, New York (Drs. Koch and Kohnen).</note><note type="content">Section title: Articles</note><note type="content">Figure 1: (Norton) Biomicroscopic photograph (A) of a rabbit eye with a PMMA IOL implanted in the capsule approximately 6 months postimplantation shows hyphema and fibrous membrane (∗). Histopathology (B) of the eye demonstrates hyphema and iris edema with proteinaceous exudate (arrow) (hematoxylin & eosin; original magnification ×400).</note><note type="content">Figure 2: (Norton) Biomicroscopic scores over time of PCO in rabbit eyes with a PMMA IOL or that received a sham surgery. All eyes exhibited time-dependent increases in the severity of both posterior capsule fibrosis and pearls. Left: Posterior capsule fibrosis. Right: Posterior capsule pearls.</note><note type="content">Figure 3: (Norton) Biomicroscopic photographs of rabbit eyes with a PMMA IOL implanted in the capsular bag at various postoperative intervals: 1 month (A); 3 months (B); 6 months (C); 12 months (D). Eyes demonstrate the time-dependent increases in the severity of PCO. At the 12 month examination, the IOL was dislocated (arrow).</note><note type="content">Figure 4: (Norton) Biomicroscopic photographs of rabbit eyes that received sham surgeries at 6 months postoperatively. A: A partial Soemmering’s ring (∗). B: A conical-shaped secondary cataract (arrow).</note><note type="content">Figure 5: (Norton) Photographs from histopathology of rabbit eyes with a PMMA IOL in the capsule 12 months postoperatively. A: Moderate fibrin in the anterior chamber (∗) and mild to moderate iris edema (arrow) (hematoxylin & eosin; original magnification ×400). B: Moderate lymphocytic infiltrate of the cornea (arrow) (hematoxylin & eosin; original magnification ×400).</note><note type="content">Table 1: Ocular scoring system used for postoperative observations.legend</note><note type="content">Table 2: Mean (Mn) and incidence (ln) of biomicroscopic (slitlamp) scores∗ in eyes with a PMMA IOL and those that received the sham surgery over time.legend</note><note type="content">Table 3: Intraocular pressure and specular microscopy scores (cellular density and percentage hexagons)∗ in eyes with a PMMA IOL and in sham eyes over time.</note><note type="content">Table 4: Incidence (I) and mean severity (S)∗ of histopathologic findings in eyes with a PMMA IOL and in sham eyes.legend</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes</title><author><persName><forename type="first">John N</forename><surname>Norton</surname></persName><roleName type="degree">DVM, PhD</roleName><note type="biography">Reprint requests to John Norton, DVM, PhD, Alcon Laboratories, Inc., MC R3-12, 6201 South Freeway, Fort Worth, Texas 76134, USA</note><note type="biography">Wendy Martin, LAT, provided technical support and Paul Greenlee, DVM, PhD, DACVP, histopathological analysis of the ocular tissues.</note><affiliation>Reprint requests to John Norton, DVM, PhD, Alcon Laboratories, Inc., MC R3-12, 6201 South Freeway, Fort Worth, Texas 76134, USA</affiliation><affiliation>Wendy Martin, LAT, provided technical support and Paul Greenlee, DVM, PhD, DACVP, histopathological analysis of the ocular tissues.</affiliation><affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</affiliation></author><author><persName><forename type="first">Thomas</forename><surname>Kohnen</surname></persName><roleName type="degree">MD</roleName><affiliation>Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA (Kohnen, Koch)</affiliation></author><author><persName><forename type="first">Robert B</forename><surname>Hackett</surname></persName><roleName type="degree">PhD</roleName><affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</affiliation></author><author><persName><forename type="first">Anil</forename><surname>Patel</surname></persName><roleName type="degree">PhD</roleName><affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</affiliation></author><author><persName><forename type="first">Douglas D</forename><surname>Koch</surname></persName><roleName type="degree">MD</roleName><affiliation>Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA (Kohnen, Koch)</affiliation></author></analytic><monogr><title level="j">Journal of Cataract & Refractive Surgery</title><title level="j" type="abbrev">JCRS</title><idno type="pISSN">0886-3350</idno><idno type="PII">S0886-3350(00)X0007-7</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1999"></date><biblScope unit="volume">25</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1467">1467</biblScope><biblScope unit="page" to="1479">1479</biblScope></imprint></monogr><idno type="istex">99D1498B07B7AE8257262B133C5BCDFF485675E3</idno><idno type="DOI">10.1016/S0886-3350(99)00237-0</idno><idno type="PII">S0886-3350(99)00237-0</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>1999</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Purpose To evaluate the appropriate duration for conducting ocular biocompatibility studies with an intraocular lens (IOL) in the pseudophakic rabbit model.Setting Alcon Laboratories, Inc., Fort Worth, Texas, USA.Methods A single-piece biconvex poly(methyl methacrylate) (PMMA) IOL was implanted in the capsular bag of 18 eyes of New Zealand white rabbits; 8 eyes received sham surgeries. Rabbits were monitored clinically and then sacrificed 6 or 12 months after surgery for histopathological examination of ocular tissues.Results Biomicroscopic examination revealed mild ocular changes in all surgical eyes during the first 3 months postoperatively. After that, there was a high incidence of posterior synechias, flare, and posterior capsule opacification (PCO) in eyes with PMMA IOLs. Posterior synechias and flare scores remained mild to moderate throughout the study, whereas PCO severity increased over time. Similar findings were observed in sham eyes. In addition, several eyes with PMMA IOLs developed IOL dislocation, hyphema, iris bombe, and a fibrous membrane covering the IOL. No discernible differences in biomicroscopic scores were observed in eyes at 6 or 12 months. Intraocular pressures and morphology of the corneal endothelium were normal in both groups. Results from histopathological analysis of the ocular tissues were consistent with observations from the biomicroscopic examinations.Conclusion The results suggest that IOL implantation studies in the pseudophakic rabbit eye should be conducted for 3 or fewer months. Regulatory guidelines requiring longer ocular implantation studies should be revised to reflect the inherently rapid and extensive ocular response in the rabbit model.</p></abstract></profileDesc><revisionDesc><change when="1999-07-09">Registration</change><change when="1999">Published</change></revisionDesc></teiHeader></istex:fulltextTEI></fulltext><metadata><istex:metadataXml wicri:clean="Elsevier, elements deleted: ce:floats; body; tail"><istex:xmlDeclaration>version="1.0" encoding="utf-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//ES//DTD journal article DTD version 4.5.2//EN//XML" URI="art452.dtd" name="istex:docType"><istex:entity SYSTEM="gr1" NDATA="IMAGE" name="GR1"></istex:entity><istex:entity SYSTEM="gr2" NDATA="IMAGE" name="GR2"></istex:entity><istex:entity SYSTEM="gr3" NDATA="IMAGE" name="GR3"></istex:entity><istex:entity SYSTEM="gr4" NDATA="IMAGE" name="GR4"></istex:entity><istex:entity SYSTEM="gr5" NDATA="IMAGE" name="GR5"></istex:entity></istex:docType><istex:document><converted-article version="4.5.2" docsubtype="fla" xml:lang="en"><item-info><jid>JCRS</jid><aid>236</aid><ce:pii>S0886-3350(99)00237-0</ce:pii><ce:doi>10.1016/S0886-3350(99)00237-0</ce:doi><ce:copyright type="society" year="1999">ASCRS and ESCRS</ce:copyright></item-info><head><ce:article-footnote><ce:label>☆</ce:label><ce:note-para>Conducted under Good Laboratory Principles (GLP) as set forth in the Code of Federal Regulations, Part 58, and supported in part by grants from the Deutsche Forschungsgemeinschaft (DFG-Ko 1595/1-1 and 1-2) (Dr. Kohnen) and Research to Prevent Blindness, New York, New York (Drs. Koch and Kohnen).</ce:note-para></ce:article-footnote><ce:dochead><ce:textfn>Articles</ce:textfn></ce:dochead><ce:title>Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes</ce:title><ce:author-group><ce:author><ce:given-name>John N</ce:given-name><ce:surname>Norton</ce:surname><ce:degrees>DVM, PhD</ce:degrees><ce:cross-ref refid="AFF1"><ce:sup>a</ce:sup></ce:cross-ref><ce:cross-ref refid="FN1"><ce:sup>1</ce:sup></ce:cross-ref><ce:cross-ref refid="CORR1">*</ce:cross-ref></ce:author><ce:author><ce:given-name>Thomas</ce:given-name><ce:surname>Kohnen</ce:surname><ce:degrees>MD</ce:degrees><ce:cross-ref refid="AFF2"><ce:sup>b</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF3"><ce:sup>c</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Robert B</ce:given-name><ce:surname>Hackett</ce:surname><ce:degrees>PhD</ce:degrees><ce:cross-ref refid="AFF1"><ce:sup>a</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Anil</ce:given-name><ce:surname>Patel</ce:surname><ce:degrees>PhD</ce:degrees><ce:cross-ref refid="AFF1"><ce:sup>a</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Douglas D</ce:given-name><ce:surname>Koch</ce:surname><ce:degrees>MD</ce:degrees><ce:cross-ref refid="AFF2"><ce:sup>b</ce:sup></ce:cross-ref></ce:author><ce:affiliation id="AFF1"><ce:label>a</ce:label><ce:textfn>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</ce:textfn></ce:affiliation><ce:affiliation id="AFF2"><ce:label>b</ce:label><ce:textfn>Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA (Kohnen, Koch)</ce:textfn></ce:affiliation><ce:affiliation id="AFF3"><ce:label>c</ce:label><ce:textfn>Johann Wolfgang Goethe-Universität, Department of Ophthalmology, Frankfurt am Main, Frankfurt, Germany (Kohnen)</ce:textfn></ce:affiliation><ce:correspondence id="CORR1"><ce:label>*</ce:label><ce:text>Reprint requests to John Norton, DVM, PhD, Alcon Laboratories, Inc., MC R3-12, 6201 South Freeway, Fort Worth, Texas 76134, USA</ce:text></ce:correspondence><ce:footnote id="FN1"><ce:label>1</ce:label><ce:note-para>Wendy Martin, LAT, provided technical support and Paul Greenlee, DVM, PhD, DACVP, histopathological analysis of the ocular tissues.</ce:note-para></ce:footnote></ce:author-group><ce:date-accepted day="9" month="7" year="1999"></ce:date-accepted><ce:abstract><ce:section-title>Abstract</ce:section-title><ce:abstract-sec><ce:section-title>Purpose</ce:section-title><ce:simple-para>To evaluate the appropriate duration for conducting ocular biocompatibility studies with an intraocular lens (IOL) in the pseudophakic rabbit model.</ce:simple-para></ce:abstract-sec><ce:abstract-sec><ce:section-title>Setting</ce:section-title><ce:simple-para>Alcon Laboratories, Inc., Fort Worth, Texas, USA.</ce:simple-para></ce:abstract-sec><ce:abstract-sec><ce:section-title>Methods</ce:section-title><ce:simple-para>A single-piece biconvex poly(methyl methacrylate) (PMMA) IOL was implanted in the capsular bag of 18 eyes of New Zealand white rabbits; 8 eyes received sham surgeries. Rabbits were monitored clinically and then sacrificed 6 or 12 months after surgery for histopathological examination of ocular tissues.</ce:simple-para></ce:abstract-sec><ce:abstract-sec><ce:section-title>Results</ce:section-title><ce:simple-para>Biomicroscopic examination revealed mild ocular changes in all surgical eyes during the first 3 months postoperatively. After that, there was a high incidence of posterior synechias, flare, and posterior capsule opacification (PCO) in eyes with PMMA IOLs. Posterior synechias and flare scores remained mild to moderate throughout the study, whereas PCO severity increased over time. Similar findings were observed in sham eyes. In addition, several eyes with PMMA IOLs developed IOL dislocation, hyphema, iris bombe, and a fibrous membrane covering the IOL. No discernible differences in biomicroscopic scores were observed in eyes at 6 or 12 months. Intraocular pressures and morphology of the corneal endothelium were normal in both groups. Results from histopathological analysis of the ocular tissues were consistent with observations from the biomicroscopic examinations.</ce:simple-para></ce:abstract-sec><ce:abstract-sec><ce:section-title>Conclusion</ce:section-title><ce:simple-para>The results suggest that IOL implantation studies in the pseudophakic rabbit eye should be conducted for 3 or fewer months. Regulatory guidelines requiring longer ocular implantation studies should be revised to reflect the inherently rapid and extensive ocular response in the rabbit model.</ce:simple-para></ce:abstract-sec></ce:abstract></head></converted-article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes</title></titleInfo><name type="personal"><namePart type="given">John N</namePart><namePart type="family">Norton</namePart><namePart type="termsOfAddress">DVM, PhD</namePart><affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</affiliation><description>Reprint requests to John Norton, DVM, PhD, Alcon Laboratories, Inc., MC R3-12, 6201 South Freeway, Fort Worth, Texas 76134, USA</description><description>Wendy Martin, LAT, provided technical support and Paul Greenlee, DVM, PhD, DACVP, histopathological analysis of the ocular tissues.</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Thomas</namePart><namePart type="family">Kohnen</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA (Kohnen, Koch)</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Robert B</namePart><namePart type="family">Hackett</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Anil</namePart><namePart type="family">Patel</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Alcon Laboratories, Inc., Fort Worth, Texas, USA (Norton, Hackett, Patel)</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Douglas D</namePart><namePart type="family">Koch</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Cullen Eye Institute, Baylor College of Medicine, Department of Ophthalmology, Houston, Texas, USA (Kohnen, Koch)</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="Full-length article"></genre><originInfo><publisher>ELSEVIER</publisher><dateIssued encoding="w3cdtf">1999</dateIssued><dateValid encoding="w3cdtf">1999-07-09</dateValid><copyrightDate encoding="w3cdtf">1999</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract lang="en">Purpose To evaluate the appropriate duration for conducting ocular biocompatibility studies with an intraocular lens (IOL) in the pseudophakic rabbit model.Setting Alcon Laboratories, Inc., Fort Worth, Texas, USA.Methods A single-piece biconvex poly(methyl methacrylate) (PMMA) IOL was implanted in the capsular bag of 18 eyes of New Zealand white rabbits; 8 eyes received sham surgeries. Rabbits were monitored clinically and then sacrificed 6 or 12 months after surgery for histopathological examination of ocular tissues.Results Biomicroscopic examination revealed mild ocular changes in all surgical eyes during the first 3 months postoperatively. After that, there was a high incidence of posterior synechias, flare, and posterior capsule opacification (PCO) in eyes with PMMA IOLs. Posterior synechias and flare scores remained mild to moderate throughout the study, whereas PCO severity increased over time. Similar findings were observed in sham eyes. In addition, several eyes with PMMA IOLs developed IOL dislocation, hyphema, iris bombe, and a fibrous membrane covering the IOL. No discernible differences in biomicroscopic scores were observed in eyes at 6 or 12 months. Intraocular pressures and morphology of the corneal endothelium were normal in both groups. Results from histopathological analysis of the ocular tissues were consistent with observations from the biomicroscopic examinations.Conclusion The results suggest that IOL implantation studies in the pseudophakic rabbit eye should be conducted for 3 or fewer months. Regulatory guidelines requiring longer ocular implantation studies should be revised to reflect the inherently rapid and extensive ocular response in the rabbit model.</abstract><note>Conducted under Good Laboratory Principles (GLP) as set forth in the Code of Federal Regulations, Part 58, and supported in part by grants from the Deutsche Forschungsgemeinschaft (DFG-Ko 1595/1-1 and 1-2) (Dr. Kohnen) and Research to Prevent Blindness, New York, New York (Drs. Koch and Kohnen).</note><note type="content">Section title: Articles</note><note type="content">Figure 1: (Norton) Biomicroscopic photograph (A) of a rabbit eye with a PMMA IOL implanted in the capsule approximately 6 months postimplantation shows hyphema and fibrous membrane (∗). Histopathology (B) of the eye demonstrates hyphema and iris edema with proteinaceous exudate (arrow) (hematoxylin & eosin; original magnification ×400).</note><note type="content">Figure 2: (Norton) Biomicroscopic scores over time of PCO in rabbit eyes with a PMMA IOL or that received a sham surgery. All eyes exhibited time-dependent increases in the severity of both posterior capsule fibrosis and pearls. Left: Posterior capsule fibrosis. Right: Posterior capsule pearls.</note><note type="content">Figure 3: (Norton) Biomicroscopic photographs of rabbit eyes with a PMMA IOL implanted in the capsular bag at various postoperative intervals: 1 month (A); 3 months (B); 6 months (C); 12 months (D). Eyes demonstrate the time-dependent increases in the severity of PCO. At the 12 month examination, the IOL was dislocated (arrow).</note><note type="content">Figure 4: (Norton) Biomicroscopic photographs of rabbit eyes that received sham surgeries at 6 months postoperatively. A: A partial Soemmering’s ring (∗). B: A conical-shaped secondary cataract (arrow).</note><note type="content">Figure 5: (Norton) Photographs from histopathology of rabbit eyes with a PMMA IOL in the capsule 12 months postoperatively. A: Moderate fibrin in the anterior chamber (∗) and mild to moderate iris edema (arrow) (hematoxylin & eosin; original magnification ×400). B: Moderate lymphocytic infiltrate of the cornea (arrow) (hematoxylin & eosin; original magnification ×400).</note><note type="content">Table 1: Ocular scoring system used for postoperative observations.legend</note><note type="content">Table 2: Mean (Mn) and incidence (ln) of biomicroscopic (slitlamp) scores∗ in eyes with a PMMA IOL and those that received the sham surgery over time.legend</note><note type="content">Table 3: Intraocular pressure and specular microscopy scores (cellular density and percentage hexagons)∗ in eyes with a PMMA IOL and in sham eyes over time.</note><note type="content">Table 4: Incidence (I) and mean severity (S)∗ of histopathologic findings in eyes with a PMMA IOL and in sham eyes.legend</note><relatedItem type="host"><titleInfo><title>Journal of Cataract & Refractive Surgery</title></titleInfo><titleInfo type="abbreviated"><title>JCRS</title></titleInfo><genre type="Journal">journal</genre><originInfo><dateIssued encoding="w3cdtf">199911</dateIssued></originInfo><identifier type="ISSN">0886-3350</identifier><identifier type="PII">S0886-3350(00)X0007-7</identifier><part><date>199911</date><detail type="volume"><number>25</number><caption>vol.</caption></detail><detail type="issue"><number>11</number><caption>no.</caption></detail><extent unit="issue pages"><start>1421</start><end>1556</end></extent><extent unit="pages"><start>1467</start><end>1479</end></extent></part></relatedItem><identifier type="istex">99D1498B07B7AE8257262B133C5BCDFF485675E3</identifier><identifier type="DOI">10.1016/S0886-3350(99)00237-0</identifier><identifier type="PII">S0886-3350(99)00237-0</identifier><accessCondition type="use and reproduction" contentType="">© 1999ASCRS and ESCRS</accessCondition><recordInfo><recordContentSource>ELSEVIER</recordContentSource><recordOrigin>ASCRS and ESCRS, ©1999</recordOrigin></recordInfo></mods></metadata><enrichments><istex:catWosTEI uri="https://api.istex.fr/document/99D1498B07B7AE8257262B133C5BCDFF485675E3/enrichments/catWos"><teiHeader><profileDesc><textClass><classCode scheme="WOS">OPHTHALMOLOGY</classCode><classCode scheme="WOS">SURGERY</classCode></textClass></profileDesc></teiHeader></istex:catWosTEI></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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