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Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens : results of the Centerflex FDA study

Identifieur interne : 000C84 ( PascalFrancis/Corpus ); précédent : 000C83; suivant : 000C85

Prospective, 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. Auffarth

Source :

British journal of ophthalmology [ 0007-1161 ] ; 2006.

RBID : Pascal:06-0350116

Descripteurs français

Pascal (Inist)
- Prospective, Randomisation, Long terme, Evaluation, Hydrophilie, Lentille intraoculaire, Ophtalmologie, Traitement.

English descriptors

KwdEn :
- Evaluation, Hydrophily, Intraocular lens, Long term, Ophthalmology, Prospective, Randomization, Treatment.

Abstract

Background: Owing to the improvement of modern intraocular lenses (lOLs) 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. 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. 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. Conclusion: 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 lOLs, which could be explained by the incomplete sharp edge at the optic-haptic junctions representing an "Achilles' heel" for cell ingrowth.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A11	`01`	`1`		`@1 BECKER (K. A.)`
A11	`02`	`1`		`@1 MARTIN (M.)`
A11	`03`	`1`		`@1 RABSILBER (T. M.)`
A11	`04`	`1`		`@1 ENTZ (B. B.)`
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A11	`06`	`1`		`@1 AUFFARTH (G. U.)`
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A44				`@0 0000 @1 © 2006 INIST-CNRS. All rights reserved.`
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C01	`01`		`ENG`	@0 Background: Owing to the improvement of modern intraocular lenses (lOLs) 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. 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. 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. Conclusion: 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 lOLs, which could be explained by the incomplete sharp edge at the optic-haptic junctions representing an "Achilles' heel" for cell ingrowth.
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C03	`06`	`X`	`FRE`	`@0 Lentille intraoculaire @5 09`
C03	`06`	`X`	`ENG`	`@0 Intraocular lens @5 09`
C03	`06`	`X`	`SPA`	`@0 Lente intraocular @5 09`
C03	`07`	`X`	`FRE`	`@0 Ophtalmologie @5 11`
C03	`07`	`X`	`ENG`	`@0 Ophthalmology @5 11`
C03	`07`	`X`	`SPA`	`@0 Oftalmología @5 11`
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Format Inist (serveur)

NO :	PASCAL 06-0350116 INIST
ET :	Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens : results of the Centerflex FDA study
AU :	BECKER (K. A.); MARTIN (M.); RABSILBER (T. M.); ENTZ (B. B.); REULAND (A. J.); AUFFARTH (G. U.)
AF :	Heidelberg IOL and Refractive Surgery Research Group, Department of Ophthalmology, Ruprecht-Karls-University of Heidelberg/Allemagne (1 aut., 2 aut., 3 aut., 4 aut., 5 aut., 6 aut.)
DT :	Publication en série; Niveau analytique
SO :	British journal of ophthalmology; ISSN 0007-1161; Coden BJOPAL; Royaume-Uni; Da. 2006; Vol. 90; No. 8; Pp. 971-974; Bibl. 36 ref.
LA :	Anglais
EA :	Background: Owing to the improvement of modern intraocular lenses (lOLs) 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. 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. 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. Conclusion: 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 lOLs, which could be explained by the incomplete sharp edge at the optic-haptic junctions representing an "Achilles' heel" for cell ingrowth.
CC :	002B09N
FD :	Prospective; Randomisation; Long terme; Evaluation; Hydrophilie; Lentille intraoculaire; Ophtalmologie; Traitement
FG :	Chirurgie
ED :	Prospective; Randomization; Long term; Evaluation; Hydrophily; Intraocular lens; Ophthalmology; Treatment
EG :	Surgery
SD :	Prospectiva; Aleatorización; Largo plazo; Evaluación; Hidrofilia; Lente intraocular; Oftalmología; Tratamiento
LO :	INIST-1015.354000138974350140
ID :	06-0350116

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Pascal:06-0350116

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<front><div type="abstract" xml:lang="en">Background: Owing to the improvement of modern intraocular lenses (lOLs) 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. 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. 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/mm<sup>2</sup>
 to 2380 (316) cells/mm<sup>2</sup>
. 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. Conclusion: 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 lOLs, which could be explained by the incomplete sharp edge at the optic-haptic junctions representing an "Achilles' heel" for cell ingrowth.</div>
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<fC01 i1="01" l="ENG"><s0>Background: Owing to the improvement of modern intraocular lenses (lOLs) 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. 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. 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/mm<sup>2</sup>
 to 2380 (316) cells/mm<sup>2</sup>
. 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. Conclusion: 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 lOLs, which could be explained by the incomplete sharp edge at the optic-haptic junctions representing an "Achilles' heel" for cell ingrowth.</s0>
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<fC02 i1="01" i2="X"><s0>002B09N</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Prospective</s0>
<s5>02</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Prospective</s0>
<s5>02</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Prospectiva</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Randomisation</s0>
<s5>03</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Randomization</s0>
<s5>03</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Aleatorización</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Long terme</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Long term</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Largo plazo</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Evaluation</s0>
<s5>06</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Evaluation</s0>
<s5>06</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Evaluación</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Hydrophilie</s0>
<s5>08</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Hydrophily</s0>
<s5>08</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Hidrofilia</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Lentille intraoculaire</s0>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Intraocular lens</s0>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Lente intraocular</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Ophtalmologie</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Ophthalmology</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Oftalmología</s0>
<s5>11</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Traitement</s0>
<s5>25</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Treatment</s0>
<s5>25</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>25</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Chirurgie</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Surgery</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Cirugía</s0>
<s5>37</s5>
</fC07>
<fN21><s1>227</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 06-0350116 INIST</NO>
<ET>Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens : results of the Centerflex FDA study</ET>
<AU>BECKER (K. A.); MARTIN (M.); RABSILBER (T. M.); ENTZ (B. B.); REULAND (A. J.); AUFFARTH (G. U.)</AU>
<AF>Heidelberg IOL and Refractive Surgery Research Group, Department of Ophthalmology, Ruprecht-Karls-University of Heidelberg/Allemagne (1 aut., 2 aut., 3 aut., 4 aut., 5 aut., 6 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>British journal of ophthalmology; ISSN 0007-1161; Coden BJOPAL; Royaume-Uni; Da. 2006; Vol. 90; No. 8; Pp. 971-974; Bibl. 36 ref.</SO>
<LA>Anglais</LA>
<EA>Background: Owing to the improvement of modern intraocular lenses (lOLs) 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. 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. 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/mm<sup>2</sup>
 to 2380 (316) cells/mm<sup>2</sup>
. 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. Conclusion: 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 lOLs, which could be explained by the incomplete sharp edge at the optic-haptic junctions representing an "Achilles' heel" for cell ingrowth.</EA>
<CC>002B09N</CC>
<FD>Prospective; Randomisation; Long terme; Evaluation; Hydrophilie; Lentille intraoculaire; Ophtalmologie; Traitement</FD>
<FG>Chirurgie</FG>
<ED>Prospective; Randomization; Long term; Evaluation; Hydrophily; Intraocular lens; Ophthalmology; Treatment</ED>
<EG>Surgery</EG>
<SD>Prospectiva; Aleatorización; Largo plazo; Evaluación; Hidrofilia; Lente intraocular; Oftalmología; Tratamiento</SD>
<LO>INIST-1015.354000138974350140</LO>
<ID>06-0350116</ID>
</server>
</inist>
</record>

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Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens : results of the Centerflex FDA study

Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens : results of the Centerflex FDA study

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