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Intraindividual aqueous flare comparison after implantation of hydrophobic intraocular lenses with or without a heparin-coated surface

Intraindividual aqueous flare comparison after implantation of hydrophobic intraocular lenses with or without a heparin-coated surface Eva M. Krall, MD, Eva-M. Arlt, MD, Gerlinde Jell, MD, Clemens Strohmaier, MD, Alexander Bachernegg, MD, Martin Emesz, MD, G€ unther Grabner, MD, Alois K. Dexl, MD, MSc PURPOSE: To assess the efficacy of a heparin-surface-modified (HSM) hydrophobic acrylicintraocular lens (IOL) (EC-1YH PAL) and the same IOL without heparin coating (EC-1Y-PAL) bythe flare and cell intensity in the anterior chamber after uneventful cataract surgery.
SETTING: Department of Ophthalmology, Paracelsus Medical University Salzburg, Austria.
DESIGN: Comparative case series.
METHODS: Routine phacoemulsification with randomized implantation of an HSM IOL in 1 eye(HSM IOL group) and an uncoated IOL (uncoated IOL group) in the fellow eye was performed.
Postoperative inflammation was assessed objectively using a laser flare–cell meter (FM-600) pre-operatively as well as 1 day and 1 and 3 months postoperatively. Aqueous cells in the anterior cham-ber, distance visual acuities, and subjective manifest refraction were also evaluated at each visit.
RESULTS: One hundred eyes (50 patients) were enrolled. In both groups, the mean flare valuesincreased significantly from preoperatively to 1 day postoperatively (P<.001) and nearly reachedpreoperative values by 3 months postoperatively. One day postoperatively, the mean flare valuewas statistically significantly lower in the HSM IOL group (14.92 photons per millisecond[ph/ms] G 7.47 [SD]) than in the uncoated IOL group (mean 16.73 G 7.81 ph/ms) (PZ.04); therewas no statistically significant difference between groups 1 and 3 months postoperatively (bothP>.58). The HSM IOL group had a greater and quicker decrease in aqueous cells, reaching statisticalsignificance 1 month postoperatively (PZ.01).
CONCLUSION: The HSM IOL showed a significant lower inflammatory reaction in the early post-operative stage with a faster disappearance of inflammatory signs.
Financial Disclosure: No author has a financial or proprietary interest in any material or methodmentioned.
J Cataract Refract Surg 2014; 40:1363–1370 Q 2014 ASCRS and ESCRS Although phacoemulsification has improved signifi- Influencing factors are modern techniques of cataract cantly, cataract surgery still induces trauma. One surgery,perioperative treatment such as preo- example is the direct trauma to the anterior uvea, perative povidone–iodine application, intracameral which is followed by a chronic immune reaction cefuroxime injection after phacoemulsificatio arising from the anterior uvea directed toward the and the IOL's biomaterial and design.
implanted intraocular lens (IOLThe clinical feature The aim of this study was to assess the efficacy of a from breakdown of the blood–aqueous barrier (BAB) new heparin-surface-modified (HSM) hydrophobic is flare in the anterior chamber.During the first day acrylic IOL (EC-1YH PAL, Aaren Scientific Inc. in after cataract surgery, a peak of flare values and cell United States; in Austria distributed by Polytech intensity is reached,declining to preoperative values GmbH as Polylens Y10 AS) and compare it with the from 3 months to 3 years postoperatively.
efficacy of the same IOL without a modified surface Q 2014 ASCRS and ESCRS 0886-3350/$ - see front matter 1363 Published by Elsevier Inc.
AQUEOUS FLARE AFTER IOL IMPLANTATION (EC-1Y PAL, Aaren Scientific Inc.). The efficacy was baseline flare value for analysis. Laser flare values were assessed by measuring the flare and cell intensity in expressed in photons per millisecond (ph/ms).
the anterior chamber after uneventful cataract surgery.
Additional subjective evaluation included slitlamp exam- ination to assess the cell intensity in the aqueous humor ac-cording to the Standardization of Uveitis Nomenclature, PATIENTS AND METHODS a standardized method for grading the presence of cells inthe anterior chamber as follows: 0 Z no cells; 1 Z 1 to 15 cells This prospective intraindividual randomized double- in field; 2 Z 16 to 25 cells in field; 3 Z 26 to 50 cells in field; blinded single-center clinical trial was performed in 4 Z dense cells [O50 cells] in field. Field size was 1.0 mm by accordance with the Declaration of Helsinki and prospec- 1.0 mm slit beam. For examination, the slitlamp was set to tively approved by the Ethics Committee, County of maximum voltage using a narrow slit beam with magnifica- Salzburg. All patients gave written informed consent before tion of 16 and illumination at 45 degree. Observation time study enrollment.
was approximately 5 seconds. The same evaluator per- Patients were eligible for inclusion if they had bilateral formed all examinations at each visit.
age-related cataract and were older than 50 years. Key exclu-sion criteria were previous ocular surgery or trauma. Other Intraocular Lenses exclusion criteria were any type of immunosuppressivedisorder, the use of systemic medications with significant On the day of surgery, patients were randomized to ocular side effects (eg, corticosteroids), uveitis, diabetes, receive the HSM IOL in 1 eye (HSM IOL group) and the intumescent cataract, and intraocular tumors.
uncoated IOL in the other eye (uncoated IOL group). TheIOL used in this study is single piece, monofocal, withopen-loop haptics and is designed for implantation in the capsular bag. It has a 6.0 mm aspheric biconvex opticalzone, a 13.0 mm total diameter, and a double squared edge The preoperative examination included manifest refrac- around the entire optic periphery. The optic is hydrophobic tion, corrected distance visual acuity (CDVA) using Early acrylate (3% water content) with an ultraviolet-light filter.
Treatment of Diabetic Retinopathy Study charts (Precision This IOL model is available with a standard uncoated Vision) at 4 meters, corrected near visual acuity, slitlamp hydrophobic surface (EC-1Y PAL) or with an HSM surface (EC-1YH PAL). The haptic angulation is 5 degrees. The Goldmann applanation tonometry. In addition, routine IOL is available in spherical ranges of C4.0 to C34.0 diop- biometry was performed using partial coherence interferom- ters (D) in 0.5 D increments.
etry (IOLMaster, Carl Zeiss Meditec AG) for axial lengthmeasurement, anterior chamber depth, and keratometry Surgical Technique readings. Intraocular lens power was calculated using theHaigis Preoperatively, the pupil was dilated with tropicamide Furthermore, laser flare–cell meter (LFCM) measurements 0.5%, phenylephrine 2.5%, and cyclopentolate 1.0%. Anes- (FM-600, Kowa Co. Ltd.) were performed preoperatively to thesia comprised retrobulbar injections of bupivacaine objectively evaluate aqueous flare in the anterior chamber; 0.5% (Bucain) and topical oxybuprocaine hydrochloride measurements were taken with the pupil dilated (phenyl- 0.4% (Novain) and cocaine eyedrops.
ephrine 2.5% and cyclopentolate 1.0%) in a dark room. The Two experienced cataract surgeons (G.G., M.E.) per- mean value of 3 valid laser flare measures with a background formed all surgeries. A 2.2 mm self-sealing corneoscleral scatter of less than 15% was calculated and used as the incision was created at the 12 o'clock position, and hydroxy-propyl methylcellulose (Medio-Clear) was injected. After acontinuous curvilinear capsulorhexis was created, phaco-emulsification and irrigation/aspiration of cortical material Submitted: May 3, 2013.
were performed in a standardized fashion. The IOL was Final revision submitted: November 19, 2013.
implanted in the capsular bag with a single-use injector Accepted: November 28, 2013.
(Comport series, RET, Inc.). After IOL implantation, theophthalmic viscosurgical device was aspirated thoroughly From the Department of Ophthalmology, Paracelsus Medical from the anterior chamber as well as retrolentally to ensure University Salzburg, Salzburg, Austria.
complete removal. Patients received cefuroxime 0.1 mL(Curocef) in the anterior chamber and topical application Supported by the Fuchs-Foundation for the Promotion of Research of ofloxacin (Floxal) and prednisolone trimethylacetate in Ophthalmology, Salzburg, Austria. Polytech GmbH, Rossdorf, Germany, financially supports the Fuchs-Foundation as the clinical Bilateral cataract surgery was performed on the same day research center of the Department of Ophthalmology, Paracelsus by the same surgeon. The surgical technique used in the Medical University Salzburg, Austria.
second eye was identical to that used in the first eye. Postop-erative treatment comprised prednisolone trimethylacetate Presented at the 54th Congress of € eyedrops for 3 weeks, ofloxacin eyedrops for 1 week, and sche Gesellschaft, Bad Ischl, Austria, May 2013, and 111th ketorolac trometamol eyedrops (Acular) for 4 weeks. Each Congress of Deutsche Ophthalmologische Gesellschaft, Berlin, medication was prescribed 3 times daily.
Germany, September 2013.
Corresponding author: Alois K. Dexl, MD, MSc, Department ofOphthalmology, Paracelsus Medical University Salzburg, M€ One day, 1 month, and 3 months postoperatively, all Hauptstraße 48, A-5020 Salzburg, Austria. E-mail: patients had a subjective aqueous flare and cell examination J CATARACT REFRACT SURG - VOL 40, AUGUST 2014 AQUEOUS FLARE AFTER IOL IMPLANTATION as well as an objective aqueous flare measurement with the One day after surgery, the increase in the mean flare LFCM. Furthermore, manifest refraction, CDVA, and uncor- values from baseline was 102.5% in the uncoated IOL rected distance visual acuity were determined.
group and 82.6% in the HSM IOL group; the differ-ences were statistically significant (P!.001). One Statistical Analysis month postoperatively, the mean flare values were All data were collected in a database. Statistical analysis statistically significantly lower than 1 day postopera- was computed with a 2-way repeated-measures analysis of tively (P!.001) but were still higher than at baseline variance (ANOVA) design and Fisher exact test, respec- (by 23.4% in uncoated IOL group and by 18.0% in tively (Sigmaplot 12, Systat Software, Inc.). A Shapiro- HSM IOL group); however, the difference in mean Wilk test was performed before the analysis to check fornormal distribution. The significance level was set to flare values between 1 month and baseline was not sta- 0.05. Post hoc t tests were performed where appropriate, tistically significant (PZ.33). Although there was a the significance level was adjusted using the Bonferroni consistent decline in mean flare values from 1 month correction for each ANOVA analysis performed, and the to 3 months postoperatively, the difference between significance level of the post hoc tests was automatically the 2 timepoints was not statistically significant corrected (by the statistical software) to 1/number of testsperformed. In statistics, the Bonferroni correction is a (PZ1.0). The mean flare values at 3 months were still method used to counteract the problem of multiple compar- higher than at baseline (by 15.7% in uncoated IOL isons.All values are given as the mean G standard devi- group and by 11.0% in HSM IOL group), although ation (SD) unless otherwise stated.
they had decreased to nearly baseline levels by thattime (PZ.94).
This study enrolled 100 eyes of 50 patients. The mean Subjective Evaluation of Cells in Anterior Chamber age of the 31 women and 19 men was 76.8 G 7.8 years At baseline, no cells were detected in any eye. How- (range 56 to 91 years). All patients had uneventful bilat- ever, 1 day postoperatively in both groups, cells were eral phacoemulsification with IOL implantation accord- present in all eyes, with the number declining consis- ing to the randomization. The mean implanted IOL tently by 1 month and 3 months after surgery. In the power was C21.8 G 2.7 D (range C16.0 to C30.0 D) HSM IOL group, the decrease was higher than in the in the uncoated IOL group and C21.8 G 2.6 D (range uncoated IOL group at every visit, with the difference C16.0 to C29.5 D) in the HSM IOL group; the differ- reaching statistical significance 1 month after surgery ence was not statistically significant. There was no (PZ.01) and At every postoperative statistically significant difference in phacoemulsifica- visit, considerably fewer cells were counted in the tion power or time between the 2 groups.
HSM IOL group than in the uncoated IOL group ac-cording to the grading scheme of the Standardization of Uveitis Nomenclature (Persistent cells There was no statistically significant difference in were clinically negligible.
subjective manifest refraction or CDVA preopera-tively between the 2 groups (both PO.05) ().
However, both groups had statistically significant Our study was designed to evaluate the proposed anti- visual improvements 1 day, 1 month, and 3 months inflammatory effect of by comparing a new HSM IOL and an identical control IOL without P!.001). There was no statistically significant differ- this modification. To eliminate possible bias and ence in any visual outcome parameter between the confounders, the study was designed as an intraindi- HSM IOL group and uncoated IOL group over the vidual randomized prospective controlled double- 3 months postoperative follow-up ( blinded clinical trial.
Heparin is an established agent used mostly for its anticoagulative effect; however, it also has antiinflam- Preoperatively, there was no statistically significant matory and antiproliferative characteristi difference in flare values measured with LFCM Ekre et al.describe antiinflammatory effects of hepa- between the 2 groups However, 1 day rin by inhibition of complement and lymphocyte postoperatively, the flare values were statistically migration. Other studies assessed heparin-induced significantly lower in the HSM IOL group than in the apoptosis in human peripheral blood neutr uncoated IOL group (P!.05) (At the exami- heparin-inhibiting neutrophil chemotaxis, the random nations 1 month and 3 months after surgery, no statis- directed locomotion tically significant difference was detected between the 2 IOL groups (and L- and P-selectines,and the inhibition of reactive J CATARACT REFRACT SURG - VOL 40, AUGUST 2014 AQUEOUS FLARE AFTER IOL IMPLANTATION Table 1. Between-group comparison of mean refractive and visual acuity results (50 patients, 100 eyes).
3 mo postop sphere (D) 3 mo postop refractive astigmatism (D) CDVA Z corrected distance visual acuity; HSM Z heparin surface modified; MRSE Z mean refraction spherical equivalent; UDVA Z uncorrected distancevisual acuity oxygen species generation by leucocytes induced by A promising approach is implantation of heparin- surface modified IOLs, which have been shown to Thus, earlier studies had the goal of minimizing decrease prostaglandin E2 production, in heparin- coated poly(methyl methacrylate (PMMA) IOLs, surgery by adding heparin to the irrigating solution resulting in less inflammation.Amon et and during cataract surgery. This reduced inflammation Trocme and Lifound less epithelioid and foreign- in adults as well as in children in the early postoper- body giant cells on specular microscopy in eyes with ative Significant risks of using crude heparin-surface modified IOLs than in otherwise iden- heparin in the irrigating solution include bleeding tical control groups. Thus, based on several studies re- and postoperative hyphema that are greater in eyes porting reduced inflammation, mainly in the early with BAB disturbance, as in cases of diabetes or postoperative stage, with heparin-coated PMMA uveitis.Thus, newer methods of using heparin in IOLs compared with uncoated PMMA IOLs, cataract surgery with fewer side effects have been heparin-coated PMMA IOLs have been recommended for use in cataract surgery as treatment of choice to J CATARACT REFRACT SURG - VOL 40, AUGUST 2014


AQUEOUS FLARE AFTER IOL IMPLANTATION Figure 1. Between-group comparison of flare values over time (HC-IOL Z heparin-coated intraocular lens [n Z 50]; UC-IOL Z uncoated intra-ocular lens [n Z 50]).
minimize inflammation,especially for at-risk using a standard 2.2 mm incision at the same position populations such as those with uveitis or diabetes.
to prevent disturbances in anterior chamber flare re- A new generation of foldable IOLs requires a sulting from different incision sizes, as described in considerably smaller self-sealing, bloodless tunnel incision, minimizing trauma and the inflammation Studies comparing different IOL materials (eg, induced by surgery. Thus, the antiinflammatory effect hydrophilic acrylic, hydrophobic acrylic, silicone) of heparin-coated PMMA IOLs disappIn found no significant difference in postoperative our patient population, all eyes had cataract surgery inflammation in a normal patient populor in Table 2. Between-group comparison of laser flare values over time.
Flare (Photons/ms) 1 day postoperative 1 mo postoperative 3 mo postoperative HSM Z heparin surface modified J CATARACT REFRACT SURG - VOL 40, AUGUST 2014


AQUEOUS FLARE AFTER IOL IMPLANTATION Table 3. Anterior chamber cell grading preoperatively andpostoperatively.
Figure 2. Between-group comparison of the presence of anterior chamber cells preoperatively (PZ1.0), 1 day postoperatively (PZ1.0), 1 month postoperatively (PZ.01), and 3 months postoper- atively (PZ.39) (HC-IOL Z heparin-coated intraocular lens [n Z50]; UC-IOL Z uncoated intraocular lens [n Z 50]).
HSM Z heparin surface modified*Grading scale according to Standardization of Uveitis No with field size set as 1.0 mm by 1.0 mm slit beam: 0 Z ! 1 cell in field; mean flare values in healthy people increase with age 1 Z 1–15 cells in field; 2 Z 16–25 cells in field; 3 Z 26–50 cells in field and decrease with pupil dilation, our study used an in-traindividual approach to eliminate this known bias aswell as unknown possible confoun an at-risk population, such as patients with uvei Because numerous variables have an effect on laser However, in a long-term follow-up of uveitis patients, flare values, we cannot compare our mean flare values Abela-Formanek et compared 5 IOL models and with those in other studies that had different inclusion heparin-surface modified hydrophilic acrylic IOLs criteria (eg, included at-risk patients with a (Biovue, Ophthalmic Innovations International, Inc.).
defect in the BAB and thus higher preoperative flare The HSM IOLs had better uveal biocompatibility values,used other techniques of surge than the other IOLs. They found a low incidence of or had other postoperative control intervals.Overall, posterior synechiae and concluded that the HSM IOL the mean of the SD between the 3 laser flare measure- was the reason for the low incidence of posterior syn- ments during every study visit was 1.81 G 0.15 ph/ms, echiae in that group.
and the maximum deviation was 10.35 ph/ms.
Although several studies comparing heparin-coated Although this is an issue worth considering, we believe PMMA IOLs and uncoated PMMA IOLs have been that this deviation is the result of a systematic error of published,there is a lack of studies comparing early postoperative inflammation after implantation Further studies are needed to compare this hydro- of HSM acrylic or silicone IOLs. We believe ours is phobic acrylic HSM IOL with other IOL materials the first report of a hydrophobic IOL with heparin sur- (with or without heparin coating) to determine the face modification. In our study, we verified that in the material with the lowest antiinflammatory potential.
early postoperative period, the inflammation was This is especially important for at-risk patients such significantly lower in the HSM IOL group than in the as those with BAB disturbances. These are the first re- group comprising an IOL that was identical but did sults with the HSM hydrophobic acrylic IOL we stud- not have heparin coating.
ied, and no long-term follow-up is available at this In our study, we used an LFCM, an objective proven method to determine aqueous flare in the anterior In conclusion, the HSM IOL showed a significantly lower inflammatory reaction with faster disappear- BABThe HSM group in our study had ance of inflammatory signs in the early postoperative lower laser flare values in the early postoperative stage. Long-term follow-up studies are needed to period with a significantly faster decrease in cells determine the possible advantages of the lower post- than the uncoated IOL group, giving credence to the operative inflammatory reaction, such as reduced pos- proposed antiinflammatory effect of heparin. Because terior capsule opacification.
J CATARACT REFRACT SURG - VOL 40, AUGUST 2014 AQUEOUS FLARE AFTER IOL IMPLANTATION  Heparin decreases postoperative inflammation when used in irrigating solutions during cataract surgery or as coating WHAT THIS PAPER ADDS Compared with the same IOL type without heparin surface modification, HSM hydrophobic acrylic IOLs had signifi- cantly less inflammation (flare and cells in the aqueous humor) on the first postoperative day and a significantly greater decline in inflammation in the first month after phacoemulsification and IOL implantation.
21. Nelson RM, Cecconi O, Roberts WG, Aruffo A, Linhardt RJ, Bevilacqua MP. Heparin oligosaccharides bind L- and P-selectin and inhibit acute inflammation. Blood 1993; 82:3253–3258.
. Accessed April 17, 2013 24. Del Vecchio PJ, Bizios R, Holleran LA, Judge TK, Pinto GL.
Inhibition of human scleral fibroblast proliferation with heparin.
Invest Ophthalmol Vis Sci 1988; 29:1272–1276. Available at: 8. Schauersberger J, Kruger A, M€ ock A, Petternel V, Abela C, Svolba G, Amon M. Long-term disorders of the blood– aqueous barrier after small-incision cataract surgery. Eye 2000; 14:61–63. Available at: . Accessed April 17, 2014 Ozkurt YB, Tas‚kıran A, Erdogan N, Kandemir B, Do fect of heparin in the intraocular irrigating solution on postopera- tive inflammation in the pediatric cataract surgery. Clin Ophthalmol 2009; 3:363–365. Available at: cessed April 17, 2014 J CATARACT REFRACT SURG - VOL 40, AUGUST 2014


AQUEOUS FLARE AFTER IOL IMPLANTATION 33. Wang G-Q, Gu H-Q, Yuan J-Q, Sun H-M, Xu Y-S. F-heparin 42. Shah SM, Spalton DJ, Smith SE. Measurement of aqueous cells modified intraocular lenses in Rhesus monkeys. Int J Ophthal- and flare in normal eyes. Br J Ophthalmol 1991; 75:348–352.
mol 2010; 3:141–144. Available at: Accessed April 17, 2014 ssed April 17, 2014 Department of Ophthalmology, Paracelsus Medical University Salzburg, Salzburg, Austria J CATARACT REFRACT SURG - VOL 40, AUGUST 2014

Source: http://www.zeiss.ru/upload/iblock/786/Heparin%20Coating%20Paper%20Krall.pdf

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