Implantable contact lens for moderate to high myopia
Identifieur interne : 003536 ( Istex/Corpus ); précédent : 003535; suivant : 003537Implantable contact lens for moderate to high myopia
Auteurs : Michel Gonvers ; Philippe Othenin-Girard ; Chantal Bornet ; Michel SickenbergSource :
- Journal of Cataract & Refractive Surgery [ 0886-3350 ] ; 2000.
Abstract
Purpose To confirm the safety, efficacy, and predictability of the surgical correction of moderate to high myopia by the ICM V3 and ICM V4 implantable contact lenses (ICLs), with emphasis on vaulting, intraocular pressure (IOP), and pigment dispersion.Setting University Eye Hospital, Lausanne, Switzerland.Methods Thirty-two eyes had implantation of an ICL. In 22 eyes with a mean spherical equivalent (SE) of −11.5 diopters (D), the target was emmetropia; in 10 eyes with a mean SE of −22.3 D, the goal was a reduction in the myopia. Nineteen eyes received the ICM V3 ICL and 13, the ICM V4 ICL. The mean follow-up was 7.4 months.Results The mean postoperative SE in the 32 eyes was –2.16 D. Best spectacle-corrected visual acuity was maintained or improved in all eyes. In the 22 eyes targeted to achieve emmetropia, 10 (45%) were within ±1.00 D; 15 (68%) had an uncorrected visual acuity of 20/40 or better and 4 (18%), of 20/20 or better. Vaulting of the ICL over the crystalline lens was more pronounced with the V4 than with the V3, and the difference was statistically significant. Subtle, localized anterior subcapsular opacification was encountered in 4 eyes. In 3 of them, the ICL (model V3) vaulting was minimal and 1 ICL (model V4) did not show any vaulting. Eighteen eyes had an IOP higher than the preoperative level, and the difference was statistically significant. No correlation was seen between final IOP and vaulting. Pigment dispersion on the ICL did not appear to be related to vaulting or ICL thickness.Conclusion Implantation of an ICL was effective in correcting moderate to high myopia of up to –17.50 D. Although the procedure appears to be safe, the predictability of the refractive outcome must be improved. The new generation of ICLs for myopia (ICM V4) offers a better vault over the crystalline lens than the older models (ICM V3), which should decrease the risk of cataract. No explanation was found for the IOP increase in several eyes 3 months or more after surgery.
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DOI: 10.1016/S0886-3350(00)00759-8
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<front><div type="abstract" xml:lang="en">Purpose To confirm the safety, efficacy, and predictability of the surgical correction of moderate to high myopia by the ICM V3 and ICM V4 implantable contact lenses (ICLs), with emphasis on vaulting, intraocular pressure (IOP), and pigment dispersion.Setting University Eye Hospital, Lausanne, Switzerland.Methods Thirty-two eyes had implantation of an ICL. In 22 eyes with a mean spherical equivalent (SE) of −11.5 diopters (D), the target was emmetropia; in 10 eyes with a mean SE of −22.3 D, the goal was a reduction in the myopia. Nineteen eyes received the ICM V3 ICL and 13, the ICM V4 ICL. The mean follow-up was 7.4 months.Results The mean postoperative SE in the 32 eyes was –2.16 D. Best spectacle-corrected visual acuity was maintained or improved in all eyes. In the 22 eyes targeted to achieve emmetropia, 10 (45%) were within ±1.00 D; 15 (68%) had an uncorrected visual acuity of 20/40 or better and 4 (18%), of 20/20 or better. Vaulting of the ICL over the crystalline lens was more pronounced with the V4 than with the V3, and the difference was statistically significant. Subtle, localized anterior subcapsular opacification was encountered in 4 eyes. In 3 of them, the ICL (model V3) vaulting was minimal and 1 ICL (model V4) did not show any vaulting. Eighteen eyes had an IOP higher than the preoperative level, and the difference was statistically significant. No correlation was seen between final IOP and vaulting. Pigment dispersion on the ICL did not appear to be related to vaulting or ICL thickness.Conclusion Implantation of an ICL was effective in correcting moderate to high myopia of up to –17.50 D. Although the procedure appears to be safe, the predictability of the refractive outcome must be improved. The new generation of ICLs for myopia (ICM V4) offers a better vault over the crystalline lens than the older models (ICM V3), which should decrease the risk of cataract. No explanation was found for the IOP increase in several eyes 3 months or more after surgery.</div>
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<abstract>Purpose To confirm the safety, efficacy, and predictability of the surgical correction of moderate to high myopia by the ICM V3 and ICM V4 implantable contact lenses (ICLs), with emphasis on vaulting, intraocular pressure (IOP), and pigment dispersion.Setting University Eye Hospital, Lausanne, Switzerland.Methods Thirty-two eyes had implantation of an ICL. In 22 eyes with a mean spherical equivalent (SE) of −11.5 diopters (D), the target was emmetropia; in 10 eyes with a mean SE of −22.3 D, the goal was a reduction in the myopia. Nineteen eyes received the ICM V3 ICL and 13, the ICM V4 ICL. The mean follow-up was 7.4 months.Results The mean postoperative SE in the 32 eyes was –2.16 D. Best spectacle-corrected visual acuity was maintained or improved in all eyes. In the 22 eyes targeted to achieve emmetropia, 10 (45%) were within ±1.00 D; 15 (68%) had an uncorrected visual acuity of 20/40 or better and 4 (18%), of 20/20 or better. Vaulting of the ICL over the crystalline lens was more pronounced with the V4 than with the V3, and the difference was statistically significant. Subtle, localized anterior subcapsular opacification was encountered in 4 eyes. In 3 of them, the ICL (model V3) vaulting was minimal and 1 ICL (model V4) did not show any vaulting. Eighteen eyes had an IOP higher than the preoperative level, and the difference was statistically significant. No correlation was seen between final IOP and vaulting. Pigment dispersion on the ICL did not appear to be related to vaulting or ICL thickness.Conclusion Implantation of an ICL was effective in correcting moderate to high myopia of up to –17.50 D. Although the procedure appears to be safe, the predictability of the refractive outcome must be improved. The new generation of ICLs for myopia (ICM V4) offers a better vault over the crystalline lens than the older models (ICM V3), which should decrease the risk of cataract. No explanation was found for the IOP increase in several eyes 3 months or more after surgery.</abstract>
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<note type="content">Figure 1: (Gonvers) Schematic representation of the basic radius in ICL models V3 and V4.</note>
<note type="content">Figure 2: (Gonvers) Pigment dispersion graded as “marked”: Clumps of pigment are deposited on the ICL along circular (white arrows) and radial (black arrows) lines.</note>
<note type="content">Figure 3: (Gonvers) Technique of measuring the ICL vaulting over the crystalline lens (CL), using a computerized picture obtained from a scanned 35 mm slitlamp slide. The white double-headed arrow shows the central thickness of the ICL, which is used by the computer as a landmark; the black double-headed arrow marks the distance to be calculated by the computer and corresponds to the central vaulting of the ICL; C = cornea; AC = anterior chamber.</note>
<note type="content">Figure 4: (Gonvers) Scattergram of preoperative versus postoperative BSCVA.</note>
<note type="content">Figure 5: (Gonvers) Scattergram of preoperative BSCVA versus postoperative UCVA.</note>
<note type="content">Figure 6: (Gonvers) Scattergram of preoperative IOP and IOP at the last follow-up visit.</note>
<note type="content">Figure 7: (Gonvers) Change in IOP after surgery compared with ICL vaulting.</note>
<note type="content">Figure 8: (Gonvers) Flare over time.</note>
<note type="content">Figure 9: (Gonvers) Vaulting of 2 types of ICL (V3 and V4).</note>
<note type="content">Figure 10: (Gonvers) Clinical grading of pigment dispersion compared with the vaulting of 32 ICLs.</note>
<note type="content">Figure 11: (Gonvers) Clinical grading of pigment dispersion compared with the thickness of 32 ICLs. Thickness of each ICL is represented by its refractive power.</note>
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<abstract xml:lang="en"><p>Purpose To confirm the safety, efficacy, and predictability of the surgical correction of moderate to high myopia by the ICM V3 and ICM V4 implantable contact lenses (ICLs), with emphasis on vaulting, intraocular pressure (IOP), and pigment dispersion.Setting University Eye Hospital, Lausanne, Switzerland.Methods Thirty-two eyes had implantation of an ICL. In 22 eyes with a mean spherical equivalent (SE) of −11.5 diopters (D), the target was emmetropia; in 10 eyes with a mean SE of −22.3 D, the goal was a reduction in the myopia. Nineteen eyes received the ICM V3 ICL and 13, the ICM V4 ICL. The mean follow-up was 7.4 months.Results The mean postoperative SE in the 32 eyes was –2.16 D. Best spectacle-corrected visual acuity was maintained or improved in all eyes. In the 22 eyes targeted to achieve emmetropia, 10 (45%) were within ±1.00 D; 15 (68%) had an uncorrected visual acuity of 20/40 or better and 4 (18%), of 20/20 or better. Vaulting of the ICL over the crystalline lens was more pronounced with the V4 than with the V3, and the difference was statistically significant. Subtle, localized anterior subcapsular opacification was encountered in 4 eyes. In 3 of them, the ICL (model V3) vaulting was minimal and 1 ICL (model V4) did not show any vaulting. Eighteen eyes had an IOP higher than the preoperative level, and the difference was statistically significant. No correlation was seen between final IOP and vaulting. Pigment dispersion on the ICL did not appear to be related to vaulting or ICL thickness.Conclusion Implantation of an ICL was effective in correcting moderate to high myopia of up to –17.50 D. Although the procedure appears to be safe, the predictability of the refractive outcome must be improved. The new generation of ICLs for myopia (ICM V4) offers a better vault over the crystalline lens than the older models (ICM V3), which should decrease the risk of cataract. No explanation was found for the IOP increase in several eyes 3 months or more after surgery.</p>
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<ce:surname>Othenin-Girard</ce:surname>
<ce:degrees>MD</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:author>
<ce:author><ce:given-name>Chantal</ce:given-name>
<ce:surname>Bornet</ce:surname>
<ce:degrees>MD</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:author>
<ce:author><ce:given-name>Michel</ce:given-name>
<ce:surname>Sickenberg</ce:surname>
<ce:degrees>MD</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:author>
<ce:affiliation id="AFF1"><ce:label>a</ce:label>
<ce:textfn>Hôpital Ophtalmique Universitaire Jules Gonin, Lausanne, Switzerland</ce:textfn>
</ce:affiliation>
<ce:correspondence id="CORR1"><ce:label>*</ce:label>
<ce:text>Reprint requests to Michel Gonvers, MD, Hôpital Ophtalmique Universitaire Jules Gonin, Avenue de France 15, CH-1004 Lausanne, Switzerland</ce:text>
</ce:correspondence>
<ce:footnote id="FN1"><ce:label>1</ce:label>
<ce:note-para>None of the authors has a financial interest in any product mentioned.</ce:note-para>
</ce:footnote>
</ce:author-group>
<ce:date-accepted day="7" month="9" year="2000"></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 confirm the safety, efficacy, and predictability of the surgical correction of moderate to high myopia by the ICM V3 and ICM V4 implantable contact lenses (ICLs), with emphasis on vaulting, intraocular pressure (IOP), and pigment dispersion.</ce:simple-para>
</ce:abstract-sec>
<ce:abstract-sec><ce:section-title>Setting</ce:section-title>
<ce:simple-para>University Eye Hospital, Lausanne, Switzerland.</ce:simple-para>
</ce:abstract-sec>
<ce:abstract-sec><ce:section-title>Methods</ce:section-title>
<ce:simple-para>Thirty-two eyes had implantation of an ICL. In 22 eyes with a mean spherical equivalent (SE) of −11.5 diopters (D), the target was emmetropia; in 10 eyes with a mean SE of −22.3 D, the goal was a reduction in the myopia. Nineteen eyes received the ICM V3 ICL and 13, the ICM V4 ICL. The mean follow-up was 7.4 months.</ce:simple-para>
</ce:abstract-sec>
<ce:abstract-sec><ce:section-title>Results</ce:section-title>
<ce:simple-para>The mean postoperative SE in the 32 eyes was –2.16 D. Best spectacle-corrected visual acuity was maintained or improved in all eyes. In the 22 eyes targeted to achieve emmetropia, 10 (45%) were within ±1.00 D; 15 (68%) had an uncorrected visual acuity of 20/40 or better and 4 (18%), of 20/20 or better. Vaulting of the ICL over the crystalline lens was more pronounced with the V4 than with the V3, and the difference was statistically significant. Subtle, localized anterior subcapsular opacification was encountered in 4 eyes. In 3 of them, the ICL (model V3) vaulting was minimal and 1 ICL (model V4) did not show any vaulting. Eighteen eyes had an IOP higher than the preoperative level, and the difference was statistically significant. No correlation was seen between final IOP and vaulting. Pigment dispersion on the ICL did not appear to be related to vaulting or ICL thickness.</ce:simple-para>
</ce:abstract-sec>
<ce:abstract-sec><ce:section-title>Conclusion</ce:section-title>
<ce:simple-para>Implantation of an ICL was effective in correcting moderate to high myopia of up to –17.50 D. Although the procedure appears to be safe, the predictability of the refractive outcome must be improved. The new generation of ICLs for myopia (ICM V4) offers a better vault over the crystalline lens than the older models (ICM V3), which should decrease the risk of cataract. No explanation was found for the IOP increase in several eyes 3 months or more after surgery.</ce:simple-para>
</ce:abstract-sec>
</ce:abstract>
</head>
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<subTitle>Short-term follow-up of 2 models</subTitle>
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<subTitle>Short-term follow-up of 2 models</subTitle>
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<name type="personal"><namePart type="given">Michel</namePart>
<namePart type="family">Gonvers</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>Hôpital Ophtalmique Universitaire Jules Gonin, Lausanne, Switzerland</affiliation>
<affiliation>Reprint requests to Michel Gonvers, MD, Hôpital Ophtalmique Universitaire Jules Gonin, Avenue de France 15, CH-1004 Lausanne, Switzerland</affiliation>
<affiliation>1 None of the authors has a financial interest in any product mentioned.</affiliation>
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<name type="personal"><namePart type="given">Philippe</namePart>
<namePart type="family">Othenin-Girard</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>Hôpital Ophtalmique Universitaire Jules Gonin, Lausanne, Switzerland</affiliation>
<affiliation>1 None of the authors has a financial interest in any product mentioned.</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Chantal</namePart>
<namePart type="family">Bornet</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>Hôpital Ophtalmique Universitaire Jules Gonin, Lausanne, Switzerland</affiliation>
<affiliation>1 None of the authors has a financial interest in any product mentioned.</affiliation>
<role><roleTerm type="text">author</roleTerm>
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<name type="personal"><namePart type="given">Michel</namePart>
<namePart type="family">Sickenberg</namePart>
<namePart type="termsOfAddress">MD</namePart>
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<affiliation>1 None of the authors has a financial interest in any product mentioned.</affiliation>
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<dateValid encoding="w3cdtf">2000-09-07</dateValid>
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<abstract lang="en">Purpose To confirm the safety, efficacy, and predictability of the surgical correction of moderate to high myopia by the ICM V3 and ICM V4 implantable contact lenses (ICLs), with emphasis on vaulting, intraocular pressure (IOP), and pigment dispersion.Setting University Eye Hospital, Lausanne, Switzerland.Methods Thirty-two eyes had implantation of an ICL. In 22 eyes with a mean spherical equivalent (SE) of −11.5 diopters (D), the target was emmetropia; in 10 eyes with a mean SE of −22.3 D, the goal was a reduction in the myopia. Nineteen eyes received the ICM V3 ICL and 13, the ICM V4 ICL. The mean follow-up was 7.4 months.Results The mean postoperative SE in the 32 eyes was –2.16 D. Best spectacle-corrected visual acuity was maintained or improved in all eyes. In the 22 eyes targeted to achieve emmetropia, 10 (45%) were within ±1.00 D; 15 (68%) had an uncorrected visual acuity of 20/40 or better and 4 (18%), of 20/20 or better. Vaulting of the ICL over the crystalline lens was more pronounced with the V4 than with the V3, and the difference was statistically significant. Subtle, localized anterior subcapsular opacification was encountered in 4 eyes. In 3 of them, the ICL (model V3) vaulting was minimal and 1 ICL (model V4) did not show any vaulting. Eighteen eyes had an IOP higher than the preoperative level, and the difference was statistically significant. No correlation was seen between final IOP and vaulting. Pigment dispersion on the ICL did not appear to be related to vaulting or ICL thickness.Conclusion Implantation of an ICL was effective in correcting moderate to high myopia of up to –17.50 D. Although the procedure appears to be safe, the predictability of the refractive outcome must be improved. The new generation of ICLs for myopia (ICM V4) offers a better vault over the crystalline lens than the older models (ICM V3), which should decrease the risk of cataract. No explanation was found for the IOP increase in several eyes 3 months or more after surgery.</abstract>
<note type="content">Section title: Article</note>
<note type="content">Figure 1: (Gonvers) Schematic representation of the basic radius in ICL models V3 and V4.</note>
<note type="content">Figure 2: (Gonvers) Pigment dispersion graded as “marked”: Clumps of pigment are deposited on the ICL along circular (white arrows) and radial (black arrows) lines.</note>
<note type="content">Figure 3: (Gonvers) Technique of measuring the ICL vaulting over the crystalline lens (CL), using a computerized picture obtained from a scanned 35 mm slitlamp slide. The white double-headed arrow shows the central thickness of the ICL, which is used by the computer as a landmark; the black double-headed arrow marks the distance to be calculated by the computer and corresponds to the central vaulting of the ICL; C = cornea; AC = anterior chamber.</note>
<note type="content">Figure 4: (Gonvers) Scattergram of preoperative versus postoperative BSCVA.</note>
<note type="content">Figure 5: (Gonvers) Scattergram of preoperative BSCVA versus postoperative UCVA.</note>
<note type="content">Figure 6: (Gonvers) Scattergram of preoperative IOP and IOP at the last follow-up visit.</note>
<note type="content">Figure 7: (Gonvers) Change in IOP after surgery compared with ICL vaulting.</note>
<note type="content">Figure 8: (Gonvers) Flare over time.</note>
<note type="content">Figure 9: (Gonvers) Vaulting of 2 types of ICL (V3 and V4).</note>
<note type="content">Figure 10: (Gonvers) Clinical grading of pigment dispersion compared with the vaulting of 32 ICLs.</note>
<note type="content">Figure 11: (Gonvers) Clinical grading of pigment dispersion compared with the thickness of 32 ICLs. Thickness of each ICL is represented by its refractive power.</note>
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<originInfo><dateIssued encoding="w3cdtf">200103</dateIssued>
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<identifier type="ISSN">0886-3350</identifier>
<identifier type="PII">S0886-3350(00)X0023-5</identifier>
<part><date>200103</date>
<detail type="volume"><number>27</number>
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<detail type="issue"><number>3</number>
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