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PubMed1998

Accelerated study on lysozyme deposition on poly(HEMA) contact lenses.

A technique was developed to accelerate lysozyme deposition on poly(HEMA) contact lenses and measure the amounts of the deposited lysozyme. This technique was for evaluation of bendazac lysine solution, a contact lens cleaning and wetting solution. Effect of temperature on lysozyme deposition on poly(HEMA) contact lenses was examined. Five temperatures ranging from 25 degrees C to 90 degrees C were chosen to examine the temperature effect. The amounts of lysozyme deposited on poly(HEMA) contact lenses at 25 C and 60 C were 0.27 microg/lens and 0.61 microg/lens, respectively. The amount increased sharply to 23 microg/lens at 70 degrees C with the maximum of 31 microg/lens at 90 degrees C. Kinetics of lysozyme deposition on poly(HEMA) contact lenses was examined at 80 degrees C. Lysozyme deposition increased sharply during the first 2 h and reached a plateau after 2 h. Effectiveness of various cleaning procedures was examined using bendazac lysine solution. When the contact lenses were washed without rubbing with fingers, the bendazac lysine reduced the amount of deposited lysozyme by more than 40% from 18.3 microg/lens to 10.6 microg/lens. The effect of bendazac lysine was most prominent when the contact lenses were shaken during storage in the presence of lysozyme in solution. If the contact lenses were cleaned by rubbing with fingers, the effect of bendazac lysine solution on the prevention of lysozyme deposition was negligible.

Biocompatible Materials↗

PubMed1998

A potentiostatic study of oxygen transmissibility and permeability through hydrogel membranes.

The permeability characteristics of membranes prepared from hydrogels of poly(2-hydroxyethylmethacrylate) (PHEMA) and poly(2-hydroxyethylmethacrylate-co-N,N-dimethylacrylamide) (PHNDA) are described. True values of the permeability and transmissibility coefficients of oxygen in the membranes are determined by using electrochemical procedures involving the measurement of the steady state current either in membranes with different thickness or in a single membrane in which its thickness is varied with layers of moistened paper. Comparison of the results obtained for the transport properties in these hydrogels with others obtained in other hydrogels permit to conclude that the degree of swelling rather than the chemical nature of the hydrogels affects the permeation properties. The chemical structure presumably only affects in high degree the chemical stability and flexibility of the hydrogel membranes.

Acrylamides↗

PubMed2000

Influence of different parameters on drug release from hydrogel systems to a biomembrane model. Evaluation by differential scanning calorimetry technique.

A comparative study on the drug release capacity of four water swellable polymeric systems was carried out by differential scanning calorimetry (DSC). The polymeric systems chosen were alpha,beta-polyaspartahydrazide (PAHy) crosslinked by glutaraldehyde (GLU) (PAHy-GLU) or by ethyleneglycoldiglycidylether (EGDGE), (PAHy-EGDGE), polyvinylalcohol (PVA) crosslinked by glutaraldehyde (PVA-GLU) and alpha,beta-poly(N-hydroxyethyl)-DL-aspartamide (PHEA) by gamma irradiation (PHEA-gamma matrices). The degree of crosslinking for PAHy-GLU, PAHy-EGDGE and PVA-GLU samples was about 0.4 and 0.8. These hydrogels were characterized as free of drugs and were loaded with diflunisal (DFN) (approximately 2.5% w/w). Diflunisal, a non-steroidal anti-inflammatory drug, has been chosen as a model drug to be incorporated into polymeric matrices to follow the release processes of a drug from these hydrogels to a model membrane made by unilamellar vesicles of dipalmitoylphosphatidylcholine (DPPC). Differential scanning calorimetry appears to be a suitable technique to follow the transfer kinetics of the drug from the controlled release system to the biomembrane model. The drug releases from all the considered polymeric hydrogels, were compared with the release observed from the drug solid form by examining the effects on the thermotropic behaviour of DPPC unilamellar vesicles. The release kinetics of the drug from hydrogels were followed at 25, 37 and 50 degrees C to evidence the influence of temperature on the drug release and on the successive transfer to biological membrane model. Particularly, it appears evident that the total amount of drug transferred and the release rate are affected by the polymer crosslinking degree (it increases with crosslinking decrease) as well as by the nature of crosslinking agent. In fact, the drug release profiles from PAHy-GLU samples are more differentiated than those from PAHy-EGDGE. The effect of parameters correlating with the properties of starting polymer, such as water-affinity, crystallinity, glass-to-rubber transition temperature and affinity towards drug molecules, has been also evaluated.

1,2-Dipalmitoylphosphatidylcholine↗

PubMed2002

The Chirila Keratoprosthesis: phase I human clinical trial.

OBJECTIVE: To undertake a preliminary safety and performance evaluation of an artificial cornea, the Chirila Keratoprosthesis, in human patients. DESIGN: A prospective, interventional case series. PARTICIPANTS: Fourteen consecutive patients with blindness of corneal origin not treatable by repeated standard penetrating keratoplasty. METHODS: Keratoprostheses were manufactured and implanted. The patients, all with preoperative visual acuity of light perception to count fingers (CF), were followed clinically in adherence to a protocol. MAIN OUTCOME MEASURES: Safety (keratoprosthesis retention, incidence of serious complications) and performance (visual acuity, comfort, appearance). RESULTS: Ninety-three percent of keratoprostheses were retained to the date of reporting, up to 2.5 years. One keratoprosthesis (7%) was removed in a manner that restored the patient's preoperative condition. All but one patient maintained their preoperative level of visual acuity or improved on it, with most achieving their estimated full potential visual acuity, (range, count fingers - 20/20). CONCLUSIONS: This keratoprosthesis is acceptably safe and has demonstrated an ability to restore vision in cases in which alternative management would have had a poor prognosis. More extensive trials are warranted.

Cornea↗

PubMed1979

Prolonged wearing contact lenses and preliminary results.

Extended wear contact lenses are sure to gain approval sometime during 1979. Four such lenses are briefly described, and the author's experience with one of them is discussed. The characteristics that differentiate these lenses from daily wear lenses are the high water content and the thinness.

Aphakia↗

PubMed1998

Encapsulation of scleral buckling materials. A study of sixty specimens.

OBJECTIVE: The purpose of the study was to obtain information on the encapsulation of two nonabsorbable biomaterials (silicone and hydrogel) used as explants in scleral buckling in retinal detachment surgery. DESIGN: The study design was a histopathologic study on a cohort of capsule fractions and complete eyes. PARTICIPANTS: Fifty-nine patients participated in this study, in which 60 specimens, including 37 hydrogel and 21 silicone capsule specimens as well as 2 whole eyes, were gathered. There were no control subjects. INTERVENTION: The capsule specimens were obtained from eyes operated on previously for scleral buckling for retinal detachment. The two whole eyes were enucleated. All specimens were studied with routine optic microscopy. MAIN OUTCOME MEASURES: Patient characteristics, type of scleral buckling, and number of operations performed were analyzed. Histologically, the capsular structure, its interface with the explant, and its different components also were studied. Remnants of the buckling material also were investigated. RESULTS: There were 45 male and 14 female patients, with a mean age of 49 years. Histologically, capsule specimens had a fibrous matrix with fibroblasts and few inflammatory cells. Eighteen (48.6%) of 37 hydrogel capsule specimens displayed hydrogel fragments surrounded by a foreign body giant cell granuloma in 16 cases. CONCLUSION: Nonabsorbable materials undergo encapsulation after implantation on the eye surface. Giant cell granuloma was observed in some hydrogel capsule specimens in relation to hydrogel fragmentation. The exact origin of this fragmentation remains unknown.

Adolescent↗

PubMed2000

De-misting condensation on intraocular lenses.

BACKGROUND: Condensation occurs rapidly on intraocular lenses (IOLs), particularly silicone IOLs, after vitrectomy and fluid-air exchange in the presence of a posterior capsulotomy and severely limits the surgeon's view of the retina. This study investigated the value of heating contact lens irrigation fluid to prevent condensation on IOLs. DESIGN: An experimental in vitro study and a noncomparative interventional case series. PARTICIPANTS: Five control eyes had temperature measurements during fluid-air exchanges. Two patients with silicone IOLs and posterior capsulotomies underwent a vitrectomy involving a fluid-air exchange with heated contact lens fluid. METHODS: An in vitro model allowed monitoring of temperature and humidity changes during condensation formation on four different IOL materials. Adjusting variables to promote evaporation rather than condensation was achieved in vitro. In vivo, intraocular temperatures were measured at various stages of five vitrectomies involving a fluid-air exchange. Finally, in two in vivo cases a blood warmer was used to heat the accessory contact lens irrigation fluid during the vitrectomy and fluid-air exchange. MAIN OUTCOME MEASURES: Successful prevention of condensation on the silicone IOL during the fluid-air exchange. RESULTS: Anterior segment temperature influences the IOL temperature, such that when it is higher than the posterior segment temperature, condensation does not form and evaporation is promoted. In vivo the temperatures in the eye are hypothermic throughout the vitrectomy. At fluid-air exchange the posterior segment heats rapidly as irrigation ceases and low specific heat gas enters. Finally, in two in vivo cases with silicone IOLs, condensation was predicted then prevented by our intervention for the duration of the fluid-air exchange. CONCLUSIONS: Heating the anterior segment by conduction from warmed irrigation fluid flowing through the irrigating contact lens represents a cheap, noninvasive, and safe means to prevent condensation on IOL materials.

Body Temperature↗

PubMed2005

[Opacification of a hydrophilic acrylic intraocular lens].

PURPOSE: To report pathological and histochemical analysis of an explanted opacified hydrophilic acrylic intraocular lens. PATIENTS: and method: A hydrophilic acrylic intraocular lens--Orion IFP3D6--was explanted 2 years after routine phacoemulsification because of its opacification associated with significant visual impairment (20/40). The intraocular lens was examined by gross and light microscopy. Full-thickness cut sections of the lens were stained with 1% alizarin red (a special stain for calcium). RESULTS: Microscopic analyses revealed the presence of granules of various sizes distributed in a line parallel to the anterior and posterior curvatures of the lens. The granules stained positively for alizarin red. CONCLUSION: Such opacification has been described with the SC60B-OUV, MDR Inc., which is also a one-piece foldable-design intraocular lens (28% hydrophilic material). The opacification of the intraocular lens occurred over various periods after surgery. Forty percent of these lenses have been explanted. Microscopic and histochemical evaluation of these intraocular lenses revealed the same type of granulation deposits within the lenses. The origin and mechanism of the opacification are still not fully understood.

Female↗

PubMed1998

Augmentation genioplasty with hard tissue replacement implants.

PURPOSE: This study assessed the soft tissue changes produced by the placement of hard tissue replacement (HTR) polymer chin implants for augmentation genioplasty and evaluated the dimensional stability as well as any bony changes associated with the implants. PATIENTS AND METHODS: The study group consisted of 18 patients (3 males, 15 females) with an average follow-up of 21.5 months (range, 12 to 44 months). All implants were placed through an intraoral incision and stabilized to the symphysis with a single 2.0-mm diameter titanium screw. Preoperative, postoperative, and long-term cephalometric radiographs were analyzed for changes in soft tissue thickness in the chin region, implant stability, and the presence of bone resorption. RESULTS: The net hard tissue chin augmentation achieved averaged 6.0 mm (range, 4.5 to 9 mm). Average preoperative soft tissue thickness was 12.1 mm (range, 11 to 14.5 mm) and postoperatively it was 10.6 mm (range, 10 to 13.5 mm). The average increase in soft tissue projection was 77.6% (range, 71.4% to 83.3%) of the implant thickness. There was no radiographic evidence of implant migration or bony resorption beneath the implant. CONCLUSIONS: HTR implants appear to be a predictable means of augmenting the chin, providing the desired aesthetic change, without causing resorption of underlying bone.

Adolescent↗

PubMed2001

Polyhydroxyethylmethacrylate-based magnetic DNA-affinity beads for anti-DNA antibody removal from systemic lupus erythematosus patient plasma.

The aim of this study is to prepare magnetic poly(2-hydroxyethylmethacrylate) (mPHEMA) beads and to investigate their utility for the removal of anti-DNA antibodies from systemic lupus erythematosus (SLE) patient plasma. mPHEMA beads, in the size range of 80-120 microm, were produced by a modified suspension technique. Then, DNA was coupled onto mPHEMA beads by carbodiimide activation. The amount of ligand coupled was changed by changing the initial concentrations of carbodiimide and DNA. Human immunoglobulin G (HIgG) and anti-DNA antibody adsorption from aqueous solutions and human plasma were examined in a batch system. mPHEMA beads were characterized by swelling tests, electron spin resonance (ESR) and scanning electron microscopy. Important results obtained in this study are as follows: the swelling ratio of mPHEMA beads was 34%. The presence of magnetite particles in the polymeric structure was confirmed by ESR. The mPHEMA beads have a spherical shape and porous structure. Maximum DNA coupling of carbodiimide activated mPHEMA beads was 4.4 mg/g. Maximum HIgG adsorption from an aqueous solution was 47.5 mg/g. Anti-DNA antibody adsorption from SLE plasma was observed as 87.6 mg/g. Non-specific HIgG adsorption was 0.1 mg/g. More than 90% of the adsorbed HIgG molecules and anti-DNA antibodies were desorbed succesfully by using NaSCN solution. It was possible to reuse these DNA-affinity beads without significant losses in the antibody adsorption capacities.

Adsorption↗

PubMed2000

Macromolecular prodrugs. VIII. Synthesis of polymer-gemfibrozil conjugates.

Gemfibrozil is covalently linked to two similar polymers: poly[alpha,beta-(N-2-hydroxyethyl-DL-aspartamide)] and poly[alpha,beta-(N-3-hydroxypropyl-DL-aspartamide)]. The synthesised polymer drug conjugates differ in average molecular mass, type of covalent bonding, length of spacer, drug-loading and solubility.

Gemfibrozil↗

PubMed2001

Macromolecular prodrugs. IX. Synthesis of polymer-fenoprofen conjugates.

Synthesis of several polymer-fenoprofen conjugates is described. Fenoprofen was first chemically modified into benzotriazolide 2 and amino acid amide derivatives: glycine fenoprofenamide (3a) and beta-alanine fenoprofenamide (3b) and their benzotriazolides 6a and 6b. Compounds 2 and 6 readily reacted with polyhydroxy aspartamide-type polymers, i.e. poly[alpha,beta-(N-2-hydroxyethyl-DL-aspartamide)] (PHEA) and poly[alpha,beta-(N-3-hydroxypropyl-DL-aspartamide)] (PHPA) forming conjugates 5, 8a,b and 9a,b, respectively. Conjugate 11 was obtained by partial aminolysis of poly-DL-(2,5-dioxo-1,3-pyrrolidinediyl) (PSI) with 2-aminoethyl fenoprofenamide (3c), followed by total aminolysis with 2-hydroxyethylamine. The synthesised polymer-drug conjugates differed in type of covalent bounding, type and/or length of spacer and drug-loading.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed2002

Macromolecular prodrugs: X. Kinetics of fenoprofen release from PHEA-fenoprofen conjugate.

The kinetics of fenoprofen release from poly[alpha,beta-(N-2-hydroxyethyl-DL-aspartamide)]-fenoprofen conjugate (PHEA-Fen) in aqueous buffer solutions (pH 10 and 1.1), simulated gastric (SGF) and intestinal fluids (SIF) was studied. In borate buffer pH 10, the following rate constants were obtained: k=0.2659 (t=60 degrees C) and k=0.0177 h(-1) (t=37 degrees C) and in glycine buffer solution pH 1.1 k=0.0036 h(-1). In SGF and SIF fenoprofen release did not occur in significant extend within 12 h. The hydrolysis of the ester bond between the polymeric carrier and fenoprofen followed the pseudo first-order kinetics, with activation energy indicative for the breakage of a sigma bond (E(a)=100.6 kJ mol(-1)). The concentration of the released fenoprofen was determined by high performance liquid chromatography (HPLC).

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed2002

Bag-in-the-lens implantation of intraocular lenses.

PURPOSE: To report a new intraocular lens (IOL) and an IOL implantation concept, the bag-in-the-lens implantation technique, designed to prevent posterior capsule opacification (PCO). SETTING: The University of Antwerp, Department of Ophthalmology, Edegem, Belgium, and the Netherlands Ophthalmic Research Institute, Department of Morphology, Amsterdam, The Netherlands. METHODS: After identical curvilinear capsulorhexes are created in both the anterior and posterior capsules, the capsules are inserted in a flange of the IOL, thus the term bag-in-the-lensas opposed to the currently used lens-in-the-bagtechnique. The IOL was implanted in an in vitro human capsular bag model and in 10 eyes of 9 patients with cataract. Lens epithelial cell (LEC) outgrowth and PCO formation were observed. RESULTS: When both capsular blades were well stretched around the IOL optic, the in vitro capsular bag model showed LEC proliferation only within the space of the remaining lens bag. The LEC proliferation was limited, and there was no tendency toward proliferation approaching the visual axis. In all 10 eyes, the optical axis remained clear during a follow-up between 4 and 15 months. CONCLUSIONS: This new IOL prevented LEC proliferation in vitro and seems promising in vivo. Target patients are those at risk of PCO including those with congenital cataract, uveitis, diabetes, or cataract extraction combined with vitrectomy.

Adolescent↗

PubMed2004

Analysis of cytoskeletal proteins in posterior capsule opacification after implantation of acrylic and hydrogel intraocular lenses.

PURPOSE: To analyze selected lens cytoskeletal proteins in posterior capsule opacification (PCO) 2 weeks after intraocular lens (IOL) implantation in rabbits. SETTING: Department of Ophthalmology, Dokkyo University School of Medicine, Tochigi, Japan. METHOD: Eight 10-week-old albino rabbits were prepared and anesthetized for phacoemulsification and aspiration of the crystalline lens and implantation of an acrylic or a hydrogel IOL. Two weeks postoperatively, the rabbits were killed and the IOLs removed for immunohistochemistry. Deparaffinized tissue sections were processed with antibodies against alpha-smooth muscle actin (alpha-SMA) and beta-crystallin to observe the types of PCO with the 2 IOL types. The proteins in the PCO tissue and the normal lens were homogenized, centrifuged, and analyzed using SDS-polyacrylamide gel electrophoresis (SDS-PAGE) densitometric analysis and Western immunoblotting for actin and vimentin. RESULTS: Immunohistochemistry demonstrated a fibroblastic cell type expressing alpha-SMA and partial regeneration of epithelial cells, resulting in a lenticular structure that stained irregularly for beta-crystallin. The immunoreactivity of fibroblast-like cells to beta-crystallin appeared weaker than that of the regenerated lenticular structure. SDS-PAGE showed variability in the content of cytoskeletal proteins in the insoluble fractions of the PCO. Degradation of the cytoskeletal components was greater with the acrylic IOL than with the hydrogel IOL. CONCLUSION: Cytoskeletal proteins expressed during the formation of PCO and IOL implantation may have potential as therapeutic target proteins to improve the biocompatibility of IOLs.

Acrylic Resins↗

PubMed1989

Results of the intercapsular technique with the IOGEL lens.

Standard biconvex 12 mm diameter IOGEL PC-1 hydrogel intraocular lenses were inserted into the eyes of 55 patients using intercapsular in-the-bag placement and extracapsular ciliary sulcus placement. All patients had senile cataracts. Endothelial specular microscopic assessment was performed preoperatively and postoperatively at six and 12 months. Viscoelastic agents were not used in any of the cases and upper haptic positioning was achieved with dialing and irrigation and iris retraction in each group, respectively. Major complications in both groups were iridocapsular synechias. This resulted in dislocation of a single haptic into the anterior chamber angle in one ciliary-sulcus-placed lens and in an updrawn pupil in one of the intercapsular cases. Pigment dispersion syndrome occurred in one case with a ciliary-sulcus-placed lens. In one case in each group a Nd:YAG laser posterior capsulotomy was performed. Whereas the visual results in each group were similar, the percentage cell loss was significantly greater in the group with lenses in the ciliary sulcus at six months postoperatively. The lower cell loss in the intercapsular group was attributed to the protective effect of the anterior capsule on the endothelium during the major intraocular manipulations.

Aged↗

PubMed1998

Staar Collamer intraocular lens: clinical results from the phase I FDA core study.

PURPOSE: To assess the early postoperative efficacy and safety of the Staar Collamer intraocular lens (IOL) in small incision cataract surgery. SETTING: Six private ophthalmology practices geographically distributed throughout the United States. METHODS: One hundred twenty-five patients with a mean age of 72.1 years were enrolled in the U.S. Food and Drug Administration (FDA) Phase 1 clinical study of the Staar Collamer IOL after having cataract removal by phacoemulsification. Of these, 107 completed 4 to 6 months of follow-up. RESULTS: At 4 to 6 months postoperatively, 97.1% of patients achieved 20/40 or better corrected visual acuity; 100% of patients without pre-existing pathology (best case) achieved the same result; both results were better than FDA grid values. No persistent sight-threatening complications were reported. Through 6 months, 4.7% of patients required a neodymium:YAG capsulotomy. No IOL dislocations or removals were reported. CONCLUSION: Results indicate that the Collamer material is safe and effective for platehaptic IOLs used in small incision cataract surgery.

Aged↗

PubMed1998

Accurate determination of effective lens position and lens-capsule distance with 4 intraocular lenses.

PURPOSE: To measure effective lens position (ELP) of 4 intraocular lenses (IOLs) using high precision and high resolution dual-beam partial coherence interferometry (PCI) and to assess the tendency of these IOLs to produce a lens-capsule distance (LCD), a possible risk factor for posterior capsule opacification. SETTING: Department of Ophthalmology, Vienna General Hospital; Institute of Medical Physics, University of Vienna, Austria. METHODS: In a retrospective study, PCI was used to measure ELP and LCD in 139 pseudophakic eyes of 110 patients with 4 IOLs: acrylic 3-piece IOL (AcrySof MA60BM); silicone 3-piece IOL without a capsular tension ring (PhacoFlex SI30) and with a capsular tension ring (PhacoFlex SI30 and Morcher Type 14); silicone plate-haptic IOL (Staar AA4203VF); and a hydrogel plate-haptic IOL (logel 1103). RESULTS: The ELP and LCD were determined with a precision of approximately 3 to 4 microns. An LCD was detected in 21% eyes with the AcrySof, 20% of eyes with the SI30 without a capsular tension ring, 10% of eyes with a capsular tension ring, 21% of eyes with the Staar, and 17% of eyes with the logel. The LCDs detected by PCI, but not by slitlamp examination, were significantly smaller than those detected by both. CONCLUSION: The amount of LCD detected by PCI was approximately the same with all IOL types (approximately 20%) except the PhacoFlex SI30 with a capsular tension ring (10%).

Acrylates↗