Ocular biocompatibility testing of intraocular lenses: a 1 year study in pseudophakic rabbit eyes
Identifieur interne : 008963 ( Main/Merge ); précédent : 008962; suivant : 008964Ocular 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></author><author><name sortKey="Kohnen, Thomas" sort="Kohnen, Thomas" uniqKey="Kohnen T" first="Thomas" last="Kohnen">Thomas Kohnen</name></author><author><name sortKey="Hackett, Robert B" sort="Hackett, Robert B" uniqKey="Hackett R" first="Robert B" last="Hackett">Robert B. Hackett</name></author><author><name sortKey="Patel, Anil" sort="Patel, Anil" uniqKey="Patel A" first="Anil" last="Patel">Anil Patel</name></author><author><name sortKey="Koch, Douglas D" sort="Koch, Douglas D" uniqKey="Koch D" first="Douglas D" last="Koch">Douglas D. Koch</name></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><idno type="wicri:Area/Istex/Curation">001562</idno><idno type="wicri:Area/Istex/Checkpoint">003492</idno><idno type="wicri:doubleKey">0886-3350:1999:Norton J:ocular:biocompatibility:testing</idno><idno type="wicri:Area/Main/Merge">008963</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><wicri:noCountry code="subField">Patel)</wicri:noCountry></affiliation></author><author><name sortKey="Kohnen, Thomas" sort="Kohnen, Thomas" uniqKey="Kohnen T" first="Thomas" last="Kohnen">Thomas Kohnen</name><affiliation><wicri:noCountry code="subField">Koch)</wicri:noCountry></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><wicri:noCountry code="subField">Patel)</wicri:noCountry></affiliation></author><author><name sortKey="Patel, Anil" sort="Patel, Anil" uniqKey="Patel A" first="Anil" last="Patel">Anil Patel</name><affiliation><wicri:noCountry code="subField">Patel)</wicri:noCountry></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><wicri:noCountry code="subField">Koch)</wicri:noCountry></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></record>Pour manipuler ce document sous Unix (Dilib)
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