Posterior chamber phakic intraocular lens for hyperopia.
Identifieur interne : 001F08 ( PubMed/Corpus ); précédent : 001F07; suivant : 001F09Posterior chamber phakic intraocular lens for hyperopia.
Auteurs : D R Sanders ; R G Martin ; D C Brown ; J. Shepherd ; M R Deitz ; M. DelucaSource :
- Journal of refractive surgery (Thorofare, N.J. : 1995) [ 1081-597X ]
English descriptors
- KwdEn :
- MESH :
Abstract
A Phase I U.S. FDA clinical study of a plate haptic posterior chamber phakic intraocular lens (STAAR Surgical Implantable Contact Lens) for treatment of hyperopia was conducted at 4 sites in the United States. The purpose of this report is to assess the short-term safety and efficacy.
PubMed: 10367572
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pubmed:10367572Le document en format XML
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<author><name sortKey="Sanders, D R" sort="Sanders, D R" uniqKey="Sanders D" first="D R" last="Sanders">D R Sanders</name>
<affiliation><nlm:affiliation>Center for Clinical Research, Chicago, IL, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Martin, R G" sort="Martin, R G" uniqKey="Martin R" first="R G" last="Martin">R G Martin</name>
</author>
<author><name sortKey="Brown, D C" sort="Brown, D C" uniqKey="Brown D" first="D C" last="Brown">D C Brown</name>
</author>
<author><name sortKey="Shepherd, J" sort="Shepherd, J" uniqKey="Shepherd J" first="J" last="Shepherd">J. Shepherd</name>
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<author><name sortKey="Deitz, M R" sort="Deitz, M R" uniqKey="Deitz M" first="M R" last="Deitz">M R Deitz</name>
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<author><name sortKey="Deluca, M" sort="Deluca, M" uniqKey="Deluca M" first="M" last="Deluca">M. Deluca</name>
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<date when="????"><PubDate><MedlineDate>1999 May-Jun</MedlineDate>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Posterior chamber phakic intraocular lens for hyperopia.</title>
<author><name sortKey="Sanders, D R" sort="Sanders, D R" uniqKey="Sanders D" first="D R" last="Sanders">D R Sanders</name>
<affiliation><nlm:affiliation>Center for Clinical Research, Chicago, IL, USA.</nlm:affiliation>
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<author><name sortKey="Martin, R G" sort="Martin, R G" uniqKey="Martin R" first="R G" last="Martin">R G Martin</name>
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<author><name sortKey="Brown, D C" sort="Brown, D C" uniqKey="Brown D" first="D C" last="Brown">D C Brown</name>
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<author><name sortKey="Shepherd, J" sort="Shepherd, J" uniqKey="Shepherd J" first="J" last="Shepherd">J. Shepherd</name>
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<author><name sortKey="Deitz, M R" sort="Deitz, M R" uniqKey="Deitz M" first="M R" last="Deitz">M R Deitz</name>
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<author><name sortKey="Deluca, M" sort="Deluca, M" uniqKey="Deluca M" first="M" last="Deluca">M. Deluca</name>
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<series><title level="j">Journal of refractive surgery (Thorofare, N.J. : 1995)</title>
<idno type="ISSN">1081-597X</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Biocompatible Materials</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Hyperopia (surgery)</term>
<term>Lens Implantation, Intraocular</term>
<term>Lens, Crystalline</term>
<term>Lenses, Intraocular</term>
<term>Methacrylates</term>
<term>Middle Aged</term>
<term>Refraction, Ocular</term>
<term>Safety</term>
<term>Treatment Outcome</term>
<term>Visual Acuity</term>
</keywords>
<keywords scheme="MESH" type="chemical" xml:lang="en"><term>Biocompatible Materials</term>
<term>Methacrylates</term>
</keywords>
<keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Hyperopia</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Lens Implantation, Intraocular</term>
<term>Lens, Crystalline</term>
<term>Lenses, Intraocular</term>
<term>Middle Aged</term>
<term>Refraction, Ocular</term>
<term>Safety</term>
<term>Treatment Outcome</term>
<term>Visual Acuity</term>
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<front><div type="abstract" xml:lang="en">A Phase I U.S. FDA clinical study of a plate haptic posterior chamber phakic intraocular lens (STAAR Surgical Implantable Contact Lens) for treatment of hyperopia was conducted at 4 sites in the United States. The purpose of this report is to assess the short-term safety and efficacy.</div>
</front>
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<DateCreated><Year>1999</Year>
<Month>07</Month>
<Day>20</Day>
</DateCreated>
<DateCompleted><Year>1999</Year>
<Month>07</Month>
<Day>20</Day>
</DateCompleted>
<DateRevised><Year>2012</Year>
<Month>11</Month>
<Day>15</Day>
</DateRevised>
<Article PubModel="Print"><Journal><ISSN IssnType="Print">1081-597X</ISSN>
<JournalIssue CitedMedium="Print"><Volume>15</Volume>
<Issue>3</Issue>
<PubDate><MedlineDate>1999 May-Jun</MedlineDate>
</PubDate>
</JournalIssue>
<Title>Journal of refractive surgery (Thorofare, N.J. : 1995)</Title>
<ISOAbbreviation>J Refract Surg</ISOAbbreviation>
</Journal>
<ArticleTitle>Posterior chamber phakic intraocular lens for hyperopia.</ArticleTitle>
<Pagination><MedlinePgn>309-15</MedlinePgn>
</Pagination>
<Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">A Phase I U.S. FDA clinical study of a plate haptic posterior chamber phakic intraocular lens (STAAR Surgical Implantable Contact Lens) for treatment of hyperopia was conducted at 4 sites in the United States. The purpose of this report is to assess the short-term safety and efficacy.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Ten patients with hyperopia between +2.50 and +10.875 D were implanted in one eye each with the posterior chamber plate phakic intraocular lens and were examined at baseline and 1 day, 1 week, 1, 3, and 6 months after surgery. Mean baseline hyperopia was +6.63 D.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">At 6 months postoperatively, 7 of 10 eyes (70%) had an uncorrected visual acuity of 20/20 or better and 10 of 10 (100%) had 20/40 or better. Eight of ten eyes (80%) had a spectacle-corrected visual acuity within 1 line of baseline; the other two eyes (20%) had an improvement of 3 lines. Mean 6-month postoperative spherical equivalent refraction was +0.20 +/- 0.61D (range, -0.50 to +1.50 D), a reduction of 6.025 D from baseline. Eight of 10 eyes (80%) were within +/-0.50 D of emmetropia, 9 eyes (90%) were within +/-1.00 D, and all eyes (100%) were within +/-1.50 D. No operative or postoperative complications or adverse reactions were observed.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Results support the short-term safety, efficacy, and predictability of the STAAR Surgical Implantable Contact Lens (plate haptic posterior chamber phakic intraocular lens) in the treatment of hyperopia.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Sanders</LastName>
<ForeName>D R</ForeName>
<Initials>DR</Initials>
<AffiliationInfo><Affiliation>Center for Clinical Research, Chicago, IL, USA.</Affiliation>
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<Author ValidYN="Y"><LastName>Martin</LastName>
<ForeName>R G</ForeName>
<Initials>RG</Initials>
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<Author ValidYN="Y"><LastName>Brown</LastName>
<ForeName>D C</ForeName>
<Initials>DC</Initials>
</Author>
<Author ValidYN="Y"><LastName>Shepherd</LastName>
<ForeName>J</ForeName>
<Initials>J</Initials>
</Author>
<Author ValidYN="Y"><LastName>Deitz</LastName>
<ForeName>M R</ForeName>
<Initials>MR</Initials>
</Author>
<Author ValidYN="Y"><LastName>DeLuca</LastName>
<ForeName>M</ForeName>
<Initials>M</Initials>
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<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType>
<PublicationType UI="D017426">Clinical Trial, Phase I</PublicationType>
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<MedlineJournalInfo><Country>UNITED STATES</Country>
<MedlineTA>J Refract Surg</MedlineTA>
<NlmUniqueID>9505927</NlmUniqueID>
<ISSNLinking>1081-597X</ISSNLinking>
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<NameOfSubstance UI="D001672">Biocompatible Materials</NameOfSubstance>
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<NameOfSubstance UI="D008689">Methacrylates</NameOfSubstance>
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<NameOfSubstance UI="C005044">hydroxyethyl methacrylate</NameOfSubstance>
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<MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D001672">Biocompatible Materials</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D005500">Follow-Up Studies</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D006956">Hyperopia</DescriptorName>
<QualifierName MajorTopicYN="Y" UI="Q000601">surgery</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="Y" UI="D019654">Lens Implantation, Intraocular</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="Y" UI="D007908">Lens, Crystalline</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="Y" UI="D007910">Lenses, Intraocular</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D008689">Methacrylates</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D012029">Refraction, Ocular</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D012449">Safety</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D014792">Visual Acuity</DescriptorName>
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