ABSTRACT
OBJECTIVE: To report 25 cases of gradual, but sometimes progressive, late-postoperative degeneration of polymethyl methacrylate (PMMA) optics of posterior chamber (PC) intraocular lens (IOL) implants, often resulting in a clinically significant visual decrease long after the implantation, sometimes to a severity that required IOL explantation/exchange. DESIGN: Analysis of explanted PC IOLs, clinical histories, and photographs. PARTICIPANTS: We analyzed 25 case histories/photographs and/or explants from 18 patients implanted in the 1980s to mid-1990s with three-piece PC IOLs with PMMA optics and with polypropylene or PMMA haptics. The IOL optic from each case had characteristic snowflake or crystalline opacifications. This condition occurred with more than one manufacturer and in some cases was restricted to certain lot numbers. METHODS: The explanted IOLs (n = 10) were studied by gross inspection and by light and scanning electron microscopy, as well as confocal and energy dispersive spectroscopy. MAIN OUTCOME MEASURES: The snowflake lesions were noted within the IOL optics. The nature of these lesions was investigated. RESULTS: Assimilation of clinical information with pathologic and morphologic profiles of all cases suggested that the snowflake opacification was a small spherical lesion surrounded by an outer pseudocapsule composed of compressed, degenerated PMMA, with a central core containing convoluted fragments of PMMA. The lesions were classified into four clinical and pathologic grades according to their density and severity. CONCLUSIONS: This is the first clinicopathologic correlative report on this complication. We postulate that manufacturing variations in some IOL models fabricated in the 1980s and early 1990s are responsible. The snowflake lesions seem to represent a destruction of the PMMA material. The cluster of lesions in implanted lenses manufactured by Surgidev was less progressive than some other models, including lenses made by IOPTEX Research Corporation. This identification of a condition previously unreported is important to alert clinicians regarding these perplexing lesions that may otherwise be considered idiopathic, with no obvious clinical hint as to their origin. The prevalence noted thus far is still too low to in any way suggest that this condition would occur in 100% of PMMA IOLs from these manufacturers. However, these late-occurring lesions, present in lens models that were implanted in hundreds of thousands of patients in the last decade or so, could have constituted a true epidemic, except that many of the patients are now deceased.
Subject(s)
Lenses, Intraocular , Polymethyl Methacrylate , Postoperative Complications , Prosthesis Failure , Device Removal , Humans , Lens Implantation, Intraocular , Microscopy, Electron, Scanning , Vision Disorders/etiologyABSTRACT
PURPOSE: To assess the development of posterior capsule opacification (PCO) with 3 modern single-piece foldable intraocular lenses (IOLs) in a histopathological study and to compare the potential preventive effects of the IOL design and biomaterial in retarding PCO. SETTING: Center for Research on Ocular Therapeutics and Biodevices, Storm Eye Institute, Medical University of South Carolina, Charleston, South Carolina, USA. METHODS: Thirty-one rabbit eyes were randomly operated on with phacoemulsification and implantation of 3 single-piece foldable lenses: a hydrophilic acrylic design, the Rayner Centerflex 570H (n = 11); a hydrophobic acrylic design, the Alcon AcrySof SA30AL (n = 10); and a silicone large-hole plate design, the Staar AA-4203VF (n = 10). Central PCO (CPCO), peripheral PCO (PPCO), and Soemmering's ring formation were evaluated 3 weeks after surgery using the Miyake-Apple posterior photographic technique. Histological sections of each globe were prepared to document capsular bag status and performance of IOL geometry. RESULTS: The acrylic IOLs (Centerflex and AcrySof) had lower CPCO and PPCO scores than the silicone plate IOL (P <.05). There was no significant difference in Soemmering's ring formation among the 3 models. Pathological evaluations revealed effective blockage of migrating lens epithelial cells (LECs) at the site of the truncated optic edge of the Centerflex and AcrySof IOLs, even in the presence of large amounts of retained/regenerative cortical material. CONCLUSIONS: The AcrySof IOL has a hydrophobic surface and the Centerflex a hydrophilic surface, but no correlation to these characteristics could be identified. The single-piece AcrySof optic geometry created a clear-cut barrier effect equal to that of its 3-piece predecessor. The anatomic profile of the Centerflex IOL shows the same characteristics. The optics of both acrylic lenses have square truncated edges that functionally block ingrowth of migrating LECs toward the central visual axis, leaving clear posterior capsules. The square optic edge was an appropriate geometric configuration to create a barrier effect. There was no effect of the biomaterial on PCO prevention.
