HapticV1, Ncbi, Merge, bibRecord, 000927

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

Identifieur interne : 000927 ( Ncbi/Merge ); précédent : 000926; suivant : 000928

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 :

The British Journal of Ophthalmology [ 0007-1161 ] ; 2006.

RBID : PMC:1857197

English descriptors

KwdEn :
- Acrylic Resins, Aged, Aged, 80 and over, Biocompatible Materials, Cataract (etiology), Endothelial Cells (pathology), Female, Follow-Up Studies, Humans, Laser Therapy, Lens Capsule, Crystalline (pathology), Lens Capsule, Crystalline (surgery), Lenses, Intraocular, Male, Materials Testing, Middle Aged, Postoperative Complications, Prospective Studies, Prosthesis Design, Recurrence.
MESH :
- chemical : Acrylic Resins, Biocompatible Materials.
- etiology : Cataract.
- pathology : Endothelial Cells, Lens Capsule, Crystalline.
- surgery : Lens Capsule, Crystalline.
- Aged, Aged, 80 and over, Female, Follow-Up Studies, Humans, Laser Therapy, Lenses, Intraocular, Male, Materials Testing, Middle Aged, Postoperative Complications, Prospective Studies, Prosthesis Design, Recurrence.

Abstract

Background

Owing to the improvement of modern intraocular lenses (IOLs) 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 IOLs, which could be explained by the incomplete sharp edge at the optic‐haptic junctions representing an “Achilles' heel” for cell ingrowth.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1857197

DOI: 10.1136/bjo.2006.092437
PubMed: 16687454
PubMed Central: 1857197

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PMC:1857197

Le document en format XML

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<author><name sortKey="Martin, M" sort="Martin, M" uniqKey="Martin M" first="M" last="Martin">M. Martin</name>
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<author><name sortKey="Rabsilber, T M" sort="Rabsilber, T M" uniqKey="Rabsilber T" first="T M" last="Rabsilber">T M Rabsilber</name>
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<author><name sortKey="Entz, B B" sort="Entz, B B" uniqKey="Entz B" first="B B" last="Entz">B B Entz</name>
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<term>Cataract (etiology)</term>
<term>Endothelial Cells (pathology)</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Laser Therapy</term>
<term>Lens Capsule, Crystalline (pathology)</term>
<term>Lens Capsule, Crystalline (surgery)</term>
<term>Lenses, Intraocular</term>
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<term>Postoperative Complications</term>
<term>Prospective Studies</term>
<term>Prosthesis Design</term>
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<keywords scheme="MESH" type="chemical" xml:lang="en"><term>Acrylic Resins</term>
<term>Biocompatible Materials</term>
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</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Endothelial Cells</term>
<term>Lens Capsule, Crystalline</term>
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</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Aged, 80 and over</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Laser Therapy</term>
<term>Lenses, Intraocular</term>
<term>Male</term>
<term>Materials Testing</term>
<term>Middle Aged</term>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Owing to the improvement of modern intraocular lenses (IOLs) 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.</p>
</sec>
<sec><title>Methods</title>
<p>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.</p>
</sec>
<sec><title>Results</title>
<p>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.</p>
</sec>
<sec><title>Conclusion</title>
<p>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 IOLs, which could be explained by the incomplete sharp edge at the optic‐haptic junctions representing an “Achilles' heel” for cell ingrowth.</p>
</sec>
</div>
</front>
</TEI>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Owing to the improvement of modern intraocular lenses (IOLs) 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.</p>
</sec>
<sec><title>Methods</title>
<p>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.</p>
</sec>
<sec><title>Results</title>
<p>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.</p>
</sec>
<sec><title>Conclusion</title>
<p>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 IOLs, which could be explained by the incomplete sharp edge at the optic‐haptic junctions representing an “Achilles' heel” for cell ingrowth.</p>
</sec>
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</front>
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<pubmed><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study.</title>
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<term>Cataract (etiology)</term>
<term>Endothelial Cells (pathology)</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Laser Therapy</term>
<term>Lens Capsule, Crystalline (pathology)</term>
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<term>Materials Testing</term>
<term>Middle Aged</term>
<term>Postoperative Complications</term>
<term>Prospective Studies</term>
<term>Prosthesis Design</term>
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<term>Biocompatible Materials</term>
</keywords>
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</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Endothelial Cells</term>
<term>Lens Capsule, Crystalline</term>
</keywords>
<keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Lens Capsule, Crystalline</term>
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<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Aged, 80 and over</term>
<term>Female</term>
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<term>Laser Therapy</term>
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<term>Male</term>
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<front><div type="abstract" xml:lang="en">Owing to the improvement of modern intraocular lenses (IOLs) 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.</div>
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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

Source :

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki