Johnson Vision Research Articles

SMILE, Topography-Guided LASIK, and Wavefront-Guided LASIK: Review of Clinical Outcomes in Premarket Approval FDA Studies.

To review clinical outcomes of the U.S. Food and Drug Administration premarket approval (PMA) studies of the three recently approved refractive surgery platforms for the correction of spherocylindrical myopia. Clinical outcomes and vector analysis of astigmatism were reviewed and compared between wavefront-guided laser in situ keratomileusis (LASIK) (WFG group) (STAR S4 IR with iDesign aberrometer; Johnson & Johnson Vision Care, Inc., Santa Ana, CA), topography-guided LASIK (TOPO group) (Allegretto Wave Eye-Q laser; Alcon Laboratories, Inc., Fort Worth, TX), and small incision lenticule extraction (SMILE group) (VisuMax laser; Carl Zeiss Meditec AG, Jena, Germany). The number of eyes included was 304, 249, and 334 for the SMILE, TOPO, and WFG groups, respectively. The WFG group had the highest preoperative spherical equivalent refraction (-6.21 ± 2.78 diopters [D]), followed by the SMILE (-5.39 ± 2.30 D) and TOPO (-4.61 ± 2.43 D) groups. At 6 months postoperatively, 83.7%, 88.9%, and 82.6% of eyes in the SMILE, TOPO, and WFG groups, respectively, had uncorrected distance visual acuity (UDVA) of 20/20 or better. SMILE showed slower visual recovery at early postoperative examinations, whereas the WFG group had a decrease in UDVA over time due to refractive regression. The mean refractive cylinder changed from -1.53 ± 0.70 D preoperatively to -0.22 ± 0.33 D at 6 months postoperatively in the SMILE group, -1.19 ± 1.23 to -0.19 ± 0.30 D in the TOPO group, and -1.77 ± 1.65 to -0.33 ± 0.36 D in the WFG group. With all three procedures, undercorrection of refractive cylinder was seen with increasing attempted correction. All three procedures demonstrated excellent outcomes, considering differences in attempted correction between studies. No obvious superiority of one technique over the others was found in astigmatic correction. [J Refract Surg. 2019;35(11):690-698.].

Retrospective analysis on the visual outcomes and photic phenomena following bilateral extended depth of focus intraocular lens implants

ObjectiveTo evaluate binocular visual outcomes and presence of photic phenomena in patients with bilateral extended depth of focus (EDF) intraocular lens (IOL) implants. DesignRetrospective consecutive case series. ParticipantsPatients above the age of 18 years without prior ocular pathology or surgery with bilateral EDF IOL implants (ZXR00; Johnson & Johnson Vision) between January 2015 and December 2017 in Canadian ophthalmology centres. MethodsPatient charts were retrospectively evaluated for binocular uncorrected distance visual acuity (UCDVA), binocular corrected distance visual acuity (CDVA), binocular uncorrected near visual acuity (UCNVA), photic phenomena (glare, halos, or dysphotopsia), complications, or reoperations. Subgroup analysis investigated the effect of monovision on the above outcomes. ResultsIn total, 87 individuals with bilateral EDF IOL implants were included in the analysis. Median logMAR pre-operative CDVA was 0.18 (0.1–0.3). The median logMAR postoperative bilateral UCDVA was 0.14 (0.00–0.18), median CDVA was 0.00 (0.00–0.10), and median UCNVA was 0.10 (0.10–0.20). Overall, 16 (18.4%) cases self-reported the presence of photic phenomena, the most common of which were halos (13.8%). Subgroup analysis determined that there was no significant difference in visual outcomes or presence of photic phenomena when stratifying patients based on the degree of postoperative monovision (p = 0.31–0.57). ConclusionsOverall, the Tecnis Symfony EDF IOL provided a reasonable range of binocular distance and near vision. Approximately 12.6% of patients self-reported any postoperative photic phenomena; however, all cases were subjectively considered mild and tolerable. Monovision had no effect on visual outcomes or the presence of photic phenomena.

The Effect of a Spectral Filter on Visual Quality in Patients with an Extended-Depth-Of-Focus Intraocular Lens

Wavelength dependence of diffractive intraocular lenses (IOLs) was recognized invitro but not yet assessed invivo. By examining pseudophakic patients who had extended-depth-of-focus diffractive implants, this spectral effect on their vision was measured clinically and the lens was tested invitro. Cross-sectional study with laboratory investigation. Twelve pseudophakic patients (23 eyes) with a Symfony lens (Johnson & Johnson Vision) were measured monocularly under red and white light at far, intermediate, and near distances. Corrected distance visual acuity (CDVA), distance-corrected intermediate visual acuity (DCIVA), and distance corrected near visual acuity (DCNVA) were assessed. Contrast sensitivity was examined at several spatial frequencies. The invitro lens modulation transfer function was measured under different spectral conditions by using an IOL metrology device. CDVA was comparable under red and white light. DCIVA and DCNVA were significantly better under white light by 0.06 and 0.09, respectively. Contrast sensitivity was slightly better with a red filter at far distance but was worse at intermediate distance, although differences were significant only at 1 frequency. Near contrast sensitivity was better under polychromatic than red light, which was significant at 3 frequencies. The invitro analysis confirmed Symfony's wavelength dependence: performance was improved at far distance but was worse at intermediate and near distances. Symfony's spectral dependence was observed to affect visual acuity and contrast sensitivity. Although the red filter did not improve distance vision, it caused visual deterioration at near distance. One should take this effect into account when optimizing the reading performance of patients with diffractive IOLs.

Analysis of Intrasession Repeatability of Ocular Aberrometric Measurements and Validation of Keratometry Provided by a New Integrated System in Mild to Moderate Keratoconus.

To evaluate the intrasession repeatability and validity of corneal curvature measurements provided by a new multifunctional device and to assess the intrasession repeatability of its ocular aberrometric measures. This prospective study comprises 37 mild to moderate keratoconus eyes of 37 patients. In all cases, 3 repeated measures of corneal topography and ocular aberrometry were performed with the iDesign 2 system (iD2; Johnson & Johnson Vision Care Inc, Jacksonville, FL) and one keratometric measurement was performed with the intraocular lens-(IOL) Master 500 (Carl Zeiss Meditec Inc, Dublin, CA) and Sirius (CSO) (SIR) systems. The within-subject SD (Sw) was <0.50 D for all iD2 keratometric measurements, with intraclass correlation coefficient (ICC) >0.980. Sw and ICC for the keratometric axis were 2.60 degrees and 0.992, respectively. Concerning aberrations, all Sw values for high-order Zernike terms were ≤0.11 μm (ICC > 0.900), and all Sw values for refraction data were <0.75 D (ICC > 0.95), except for J45. No statistically significant differences were found between the devices in any keratometric parameter evaluated (P ≥ 0.222), but the limits of agreement between the devices were clinically relevant. The magnitude of K readings and astigmatism correlated significantly with the difference in these parameters between iD2 and SIR (0.432 ≤ r ≤ 0.489, P ≤ 0.041). The iD2 system provides consistent measures of keratometry and ocular aberrometry in eyes with mild to moderate keratoconus. Keratometric data obtained with this system in these eyes cannot be considered as interchangeable with data provided by intraocular lens-Master 500 and SIR.

Comprehensive Evaluation of Retinal Image Quality in Comparing Different Aspheric to Spherical Intraocular Lens Implants

ABSTRACTPurpose: To compare the visual and optical quality of eyes implanted with three aspheric versus two spherical intraocular lenses (IOL) after cataract surgery.Methods: This prospective comparative study included 349 eyes of 349 patients with age-related cataract and undergone uneventful phacoemulsification. Implanted posterior monofocal IOLs have an aspheric optic (Tecnis ZCB00 [Johnson & Johnson Vision], Acrysof IQ SN60WF [Alcon], Akreos AO [Bausch & Lomb]) or a spherical optic (Akreos [Bausch & Lomb], Sensar AR40e [Johnson & Johnson Vision]). Postoperatively, objective optical quality parameters were performed using an Optical Quality Analysis System II (Visiometrics), and wave-front aberrations were assessed using a KR-1W aberrometer (Topcon). Meanwhile, subjective visual acuity was performed using a logarithm of the minimum angle of resolution chart at 3 months after cataract surgery.Results: Statistical significant differences (P < .05) across all groups were found regarding intraocular and total ocular spherical aberration (SA) at 4.0 mm and 6.0 mm pupil diameter and total high-order aberration (tHOA) at 6.0 mm pupil diameter. Furthermore, differences among the evaluated groups were observed regarding several objective parameters such as objective scatter index (OSI), modulation transfer function cutoff (MTF cutoff), Strehl ratio (SR) at two dimensions and contrast visual acuity (OV) at three contrast levels.Conclusions: The present results reflect the optical characteristics of IOL in vivo. The scattering light and high-order aberration may be the main reasons for the degradation of retinal imaging quality in comparing different aspheric to spherical IOL implants.

Safety First - Evaluation of IOL Injector Systems

Improvements in cataract surgery led to the availability of preloaded IOL delivery systems. These are expected to reduce overall surgery time while being safe and effective. This study evaluates the safety and manageability of the 2-component autoloading system SAFELOADER® (HumanOptics AG, Erlangen, Germany) and compares these results to two other systems. A total of 167 eyes were enrolled to this single centre prospective study. In 67 eyes, the IOLs were implanted via the SAFELOADER system, in 50 eyes via another preloaded system (TECNIS iTec® Preloaded Delivery System, Johnson & Johnson Vision, Santa Ana, CA, USA) and in 50 eyes via a manual implantation system (UNFOLDER® Platinum 1 Series Delivery System, Johnson & Johnson Vision, Santa Ana, CA, USA). IOL preparation time and implantation time were measured in seconds for each device. The OR workflow and handling of the device by the surgeon and the scrub nurse were rated by a grading system from 1 (very good) to 5 (very poorly). The SAFELOADER and iTec were faster and handier than the manually loaded system. Regarding preparation time, the SAFELOADER with a median of 6.5 (5.3 - 6.9) seconds (s) was about one second slower (p < 0.0001) than iTec with 5.2 s (4.5 - 6.5). Both were significantly faster (p < 0.0001) than the UNFOLDER with 26.9 s (20.6 - 30.1). Implantation time was similar between SAFELOADER with 7.2 s (5.3 - 8.6), iTec with 7.3 s (5.9 - 8.3) and UNFOLDER with 7.2 s (5.9 - 7.6). When graded, SAFELOADER 2.0 (1.0 - 3.0) and iTec 1.0 (1.0 - 3.0) were significantly (p < 0.0001) better than the manual system 5.0 (3.0 - 5.0) with respect to overall OR workflow. The surgeon rated the handling of SAFELOADER and iTec (both median 1.0; 1.0 - 2.0) similarly and significantly better (p < 0.001) than that of the UNFOLDER 2.5 (1.0 - 4.0). For the scrub nurse, SAFELOADER 1.0 (1.0 - 2.0) was significantly better (p < 0.0001) in handling than iTec 2.0 (1.0 - 3.0) and UNFOLDER 4.0 (2.0 - 5.0). The 2-component autoloading system SAFELOADER® is intuitive in handling, fast and effective in implantation of the IOL and very safe.

Five-Year Cumulative Incidence and Risk Factors of Nd:YAG Capsulotomy in 10 044 Hydrophobic Acrylic 1-Piece and 3-Piece Intraocular Lenses

To evaluate the 5-year cumulative incidence and risk factors of Nd:YAG capsulotomy between hydrophobic acrylic intraocular lenses (IOLs). A retrospective cohort study. A review of the registry of operations between the years 2007 and 2016 was carried out at the Ophthalmology Unit of Kymenlaakso Central Hospital, Kotka, Finland. A total of 10 044 eyes having cataract surgery and in-the-bag implantation of ZCB00 (Abbott Medical Optics Johnson & Johnson Vision, Inc, Abbott Park, Illinois, USA), SN60WF (Alcon Laboratories, Inc, Fort Worth, Texas, USA), or ZA9003 (Abbott Medical Optics Johnson & Johnson Vision, Inc) IOLs were included in the study. The cumulative incidence of Nd:YAG capsulotomy was estimated with competing risks methodology. Competing risks regression modeling was used to evaluate potential risk factors, including the patient's age, sex, type of IOL, dioptric power of IOL, and operating surgeon's seniority. The 5-year cumulative incidence of Nd:YAG capsulotomy after cataract surgery was 13.2% (95% confidence interval [CI] 12.5%-14.0%) for all eyes and 18.1% (16.5%-20.0%), 11.5% (10.5%-12.6%), and 9.6% (8.2%-11.4%) for ZCB00, SN60WF, and ZA9003 IOLs, respectively. Implantation of SN60WF and ZA9003 IOLs was associated with a 38% and 47% subhazard reduction (SHR), respectively, compared to ZCB00, after accounting for other predictors (SHR= 0.62; 95% CI 0.54-0.71; P < .001 and SHR= 0.53; 95% CI 0.43-0.64; P < .001). Increased risk of Nd:YAG capsulotomy was associated with eyes of patients aged younger than 60 years, female sex, and eyes implanted with an IOL of <22.5 diopters power. Real-world evidence suggests that the cumulative incidence of Nd:YAG capsulotomy is significantly lower in eyes receiving SN60WF orZA9003 IOLs compared to ZCB00.

Refractive predictability and visual outcomes of an extended range of vision intraocular lens in eyes with previous myopic laser in situ keratomileusis.

To evaluate the refractive predictability obtained with an extended range of vision intraocular lens in eyes with previous myopic laser in situ keratomileusis, confirming which intraocular lens power formula provides the most accurate calculation. The study enrolled 71 eyes with previous successful myopic laser in situ keratomileusis surgery of 43 patients undergoing cataract surgery with implantation of the extended range of vision intraocular lens TECNIS Symfony (Johnson and Johnson Vision). Intraocular lens power was calculated using all American Society of Cataract and Refractive Surgeons formulas, and their average value was selected for implantation. Refractive outcomes were evaluated at 3 months postoperatively. Postoperative spherical equivalent within ±0.50 and ±1.00 D was found in 61.6% and 86.3% of eyes, respectively. In eyes with pre-laser in situ keratomileusis data available, no significant correlation was found between pre-laser in situ keratomileusis spherical equivalent and post-cataract surgery spherical equivalent (r = 0.237, p = 0.114). A postoperative spherical equivalent within ±0.50 D was found in 65.2% and 55.6% of eyes in the subgroups with and without pre-laser in situ keratomileusis data available, respectively (p = 0.480). Statistically significantly higher differences between the intraocular lens power implanted and the calculation provided by the Potvin-Hill (p = 0.028) and Barrett True K No History formulas (p = 0.022) were found in those eyes with postoperative spherical equivalent > 0.50 D. The extended range of vision intraocular lens evaluated can provide a predictable refractive correction in eyes with previous laser in situ keratomileusis surgery. The Potvin-Hill and Barrett True K No History are the most adequate formulas to perform intraocular lens power calculations in these cases.

Contralateral eye comparison of the phacoemulsification metrics, patient experience and clinical outcomes in patients undergoing bilateral cataract surgery with two commonly used femtosecond laser systems.

PurposeThe purpose of the study was to compare phacometrics, patient experience factors and clinical outcomes in patients undergoing bilateral laser-assisted cataract surgery using two common femtosecond laser platforms.SettingThis study was conducted in Beverly Hills Institute of Ophthalmology, Beverly Hills, California, USA.Study designThis was a prospective, comparative, contralateral eye study.MethodsFemtosecond laser-assisted cataract surgery was performed in the first eye of 50 patients with bilateral cataract (mean age 69.9 ± 8.61 years) using either the Catalys (Johnson & Johnson Vision) or the LenSx (Alcon Laboratories, Inc.) laser system. The fellow eye was treated with the laser not used in the first eye. The primary outcome measures included overall procedural times, and the secondary outcome measures included patient experience with the two laser systems.ResultsThere were no statistical differences between the two groups in terms of patient interface preparation time and number of docking attempts as well as effective phaco time, average phaco power, total ultrasound time and nucleus removal time. However, the LenSx group demonstrated a significantly longer cortex removal time and higher perception of pressure and vision loss (p < 0.001) compared to the Catalys group. A significantly higher number of Catalys eyes achieved complete capsulotomy (p < 0.001). The ease of cortex removal was also better in the Catalys group. Postoperative visual acuity, keratometry, endothelial cell count and intraocular pressure were comparable in the two groups.ConclusionWith similar phacometric and clinical outcomes, both laser platforms were efficient, safe and effective during cataract surgery; however, the Catalys group demonstrated superior outcomes in terms of the patient experience, completeness of capsulotomy and ease of cortex removal.

Extended depth of focus intraocular lenses for presbyopia.

To summarize the various extended depth of focus (EDOF) intraocular lenses currently available to patients and to describe visual outcomes and patient satisfaction. EDOF lenses are a relatively new option for presbyopic correction. Preliminary studies show high levels of spectacle independence and patient satisfaction. The only United States Federal Drug Administration-approved intraocular lens currently on market is the TECNIS Symfony (Johnson and Johnson Vision, Jacksonville, FL). Early studies show that EDOF lenses may provide satisfactory near and intermediate vision with reduced incidence of haloes and glares often noted by patients implanted with multifocal lenses. Results are promising, but limited.

Simulation of the Effect of Different Presbyopia-Correcting Intraocular Lenses With Eyes With Previous Laser Refractive Surgery.

To simulate the optical performance of three presbyopia-correcting intraocular lenses (IOLs) implanted in eyes with previous laser refractive surgery. A simulation of the through-focus modulation transfer function (MTF) was performed for three presbyopia-correcting IOLs (Mplus, Oculentis GmbH, Berlin, Germany; Symfony, Johnson & Johnson Vision, Santa Ana, CA; and Mini Well, SIFI S.p.A., Lavinaio, Italy) in one eye with previous myopic LASIK and another with hyperopic LASIK. Real topographic data and the wavefront aberration profile of each IOL obtained with a Hartmann-Shack sensor were used. In the eye with myopic LASIK, all IOLs lost optical quality at near and intermediate distances for 4- and 4.7-mm pupil size. For 3-mm pupil size, the Mini Well IOL showed the best intermediate and near MTF and maintained the far focus independently of the pupil. In the eye with hyperopic LASIK, the Mini Well IOL showed an intermediate, distance, and -4.00-diopter (D) foci for all pupils. The Symfony IOL showed a depth of focus at far and intermediate distance for 3-mm and a focus at -2.50 D in the rest. The Mplus showed a focus of -4.50 and -3.00 D for the 3- and 4-mm pupil, respectively. The Mini Well and Symfony IOLs seem to work better than the Mplus IOL in eyes with previous myopic LASIK. With previous hyperopic LASIK, the Mini Well IOL seems to be able to provide acceptable near, intermediate, and far foci for all pupil sizes. These findings should be confirmed in future clinical studies. [J Refract Surg. 2018;34(4):222-227.].

Evaluation of Clinical Outcomes after LASIK for the Correction of Myopia Using the Advanced Customvue Excimer Laser Platform

-Purpose: To evaluate early visual, refractive and aberrometric outcomes after wave front-guided LASIK for the correction of low to moderate myopia and myopic astigmat is musing the excimer laser platform Advanced Custom Vue. Methods: A prospective, non-comparative study in 100 myopic eyes of 50 patients evaluating LASIK results over a period of 3 months. Main outcome variables included visual acuity, refraction, total higher-order aberrations (HOAs), spherical aberration (SA) and coma-like aberration. The surgery was performed using the VISX STAR S4 (Johnson and Johnson Vision) excimer laser and a wave front-guided ablation designed according to the iDesign aberrometer data (Johnson and Johnson Vision). Results: Mean preoperative sphere decreased from -4.07 ± 1.78 D to 0.32 ± 0.30 D at 3 months after surgery. Mean preoperative cylinder was reduced from -1.09 ± 0.88 D to -0.26 ± 0.28 D after the complete follow-up. Postoperative uncorrected distance visual acuity (UDVA) was 0.00 logMAR (20/20) or better in 100% of eyes, and 65.3% of eyes reached an UDVA of -0.20 logMAR (20/12.5) or better (p < 0.05). For a 6-mm pupil, the root mean square (RMS) for total ocular HOAs increased with surgery by 0.03 μm (p = 0.050), whereas the coma-like RMS increased by 0.05 μm (p < 0.001). The change in spherical aberration was +0.08 μm (p < 0.001). Conclusion: Wavefront-guided LASIK using the new generation excimer laser platform Advanced Custom Vue is safe and effective for treating myopia and myopic astigmatism, minimizing the postoperative level of HOAs.

High performance vision

Scientists and clinicians Xu Cheng, Thomas Maggio, Bart Johnson, Brian Pall and Chantal Coles-Brennan at Johnson &amp; Johnson Vision help us understand what might be happening when a patient tells you things look sharper, brighter or clearer with their new contact lenses.

Non-Penetrating Femtosecond Laser Intrastromal Astigmatic Keratotomy Performed during Laser-Assisted Cataract Surgery: Results on Keratometric Astigmatism

Purpose: To investigate the efficacy of non-penetrating femtosecond laser intrastromal astigmatic keratotomy (ISAK) in terms of topographic and refractive changes. Methods: Retrospective study including 42 eyes (35 patients) with a corneal astigmatism between 0.5 and 1.5 D. All eyes underwent femtosecond laser-assisted cataract surgery with ISAK for astigmatism management using the Catalys laser system (Johnson & Johnson Vision). Visual acuity, refraction, as well as corneal topographic and corneal endothelial cell density (ECD) changes were evaluated during a 12-month follow-up. Astigmatic changes were analyzed using the Alpins vector method. Results: A significant reduction in manifest cylinder was observed at 1 month postoperatively (p = 0.03), with no significant changes afterwards (p = 0.90). A total of 38.1%, 52.4% and 59.2% of eyes had a manifest cylinder of 0.50 D or lower preoperatively and at 1 and 12 months after surgery, respectively. A significant reduction was found in topographic astigmatism at 1 month postoperatively (p

Samuel Johnson and the Journey into Words by Lynda Mugglestone

Samuel Johnson and the Journey into Words by Lynda Mugglestone John Considine (bio) Samuel Johnson and the Journey into Words by Lynda Mugglestone. Oxford and New York: Oxford University Press, 2015. Pp. xi + 290. $40.00. ISBN: 978-0-19-967990-4. Participants in a dictionary conference co-organized by Lynda Mugglestone in the year in which this book was published found a keepsake in their conference packages: a little square mat of the sort on which one puts a cup or glass, inscribed COASTER (n.s.) He that sails timorously near the shore. Samuel Johnson, A Dictionary of the English Language (1755).1 Those coasters anticipated this book in two ways: they encouraged their readers to think about Johnson's sense of his own work and about the connectedness of the words which he handled. Johnson's sense of his own work is revealed by the surprising word in his definition of coaster, which is "timorously": there were obvious ordinary reasons for many seagoing vessels in the eighteenth century to stay within sight of the coast. To be sure, the definition is motivated by the sole quotation which follows, from Dryden: "In our small skiff we must not launch too far; | We here but coasters, not discov'rers are." But the second of the two quotations in the previous entry, for the transitive verb coast, in which Addison writes of the pleasures of coasting the shore of Italy, had just told Johnson that not all coasting is timorous. He had his own reasons to see coasting as a metaphor for a poor, timorous activity, and to see himself as a discoverer on the wide seas. Those reasons give Samuel Johnson and the Journey into Words its opening, which introduces some of Johnson's imagery of himself as traveler and discoverer, and some of the imagery which precedes it in monolingual and bilingual dictionaries of English, in a sequence which runs backwards from Edward Phillips's New World of English Words of 1658 to the text by Thomas Blount in which Phillips found the image, and thence to John Florio's Worlde of Wordes of 1598. Mugglestone reflects here that the English language is, for Johnson, "variously a territory [End Page 123] to be conquered, and a terrain to be laboriously traversed" (16). The second chapter has the Plan of a Dictionary of 1747 at its center, and attends in particular to the shaping of the Plan in two preliminary manuscripts by Johnson and in the annotations on them by the Earl of Chesterfield, Johnson's old friend John Taylor of Ashbourne, and others. Images of the lexicographer's conquest of a language and his authority over it are again relevant here. The third chapter turns to Johnson's reading for the Dictionary, with an eye to his images of travel, and the fourth to questions of the exercise of prescriptive authority in the dictionary, with some excellent material on Johnson's acceptance of variation, particularly in spelling. The fifth turns to Johnson's definitions, describing the subtle interplay of description and prescription in the Dictionary, and arguing against the not-yet-extinct view of his procedure as basically dogmatic and prescriptive. (Mugglestone does not, of course, deny that Johnson sometimes condemned usage rather than reporting it neutrally, and gives some nice examples, such as his objection to Gay's image of turnips which "hide their swelling heads" in the ground: the head, Johnson felt, must be the highest part of an entity.) The sixth addresses Johnson's treatment of loanwords at different stages of naturalization, again showing his readiness to be flexible, and suggesting his own inconsistency in the treatment of a subject in which it is so hard to be consistent. A seventh chapter turns to Johnson's vision in the Dictionary of the history, and hence the unstable quality, of the English language, as opposed to the ideal of stability which appears in the Plan, pointing out, for instance, the appearance of the early Middle English chronicler Robert of Gloucester in a couple of dictionary entries as well as in the preliminary history of the language (173–74). It would have been possible to say more about...

Does a surface coating inhibit bacterial adhesion on silicone hydrogel contact lenses

Event Abstract Back to Event Does a surface coating inhibit bacterial adhesion on silicone hydrogel contact lenses Kevin Mccabe1 1 Johnson & Johnson Vision Care inc, Research & Development, United States Purpose: Adhesion of bacteria to contact lens (CL) surfaces is a major contributory factor in the development of CL adverse events. This study sought to determine if surface treating silicone hydrogel (SiHy) CL offers any substantial benefits against adhesion of gram positive and negative bacteria. Method: Two surface-treated SiHy CL (lotrafilcon B; delefilcon A) & 3 uncoated SiHy CL (comfilcon A; samfilcon A; senofilcon A) from manufacturers packaging were soaked in an artificial tear mimicking solution for 15 h under rotative agitation at 35°C. Lenses (n=15) were then rinsed and challenged with either P aeruginosa ATCC 9027 & S. aureus ATCC 25923, using an inoculum of approx. 1x106 colony forming units per milliliter (CFU/mL) for 15 h. Adherent bacteria were recovered and the bacterial supernatant was enumerated for viable microorganisms by a spiral plate technique. CFU counts were determined using an automated colony counter. Results: The 2 surface-treated SiHy CL (lotrafilcon B and delefilcon A) exhibited average Log colony forming units (CFU) of 5.64 & 5.86 for P. aeruginosa and 3.74 & 3.83 for S. aureus respectively. The counts for the 3 uncoated SiHy CL (comfilcon A; samfilcon A; senofilcon A) were 5.86, 5.86 & 5.70 for P. aeruginosa and 3.89, 3.85 & 4.02 for S. aureus. No significant difference was determined between surface-treated and untreated materials (p=0.268). P. aeruginosa exhibited a higher propensity to adhere to the materials than S. aureus (p<0.001). Conclusions: In vitro bacterial adhesion was not modified by applying a surface treatment to the lens materials evaluated and all materials accumulated the gram negative bacteria to a greater extent than the gram positive organism. This suggests that the surface treatments applied to lotrafilcon B and delefilcon A does not provide a protective effect from bacterial adhesion. Further evaluation of the materials post-wear is required to validate the clinical relevance of these in vitro findings. Centre for Contact lens research at the University of Waterloo Conference: 10th World Biomaterials Congress, Montréal, Canada, 17 May - 22 May, 2016. Presentation Type: Poster Topic: Biomaterials for ophthalmic applications Citation: Mccabe K (2016). Does a surface coating inhibit bacterial adhesion on silicone hydrogel contact lenses. Front. Bioeng. Biotechnol. Conference Abstract: 10th World Biomaterials Congress. doi: 10.3389/conf.FBIOE.2016.01.02416 Copyright: The abstracts in this collection have not been subject to any Frontiers peer review or checks, and are not endorsed by Frontiers. They are made available through the Frontiers publishing platform as a service to conference organizers and presenters. The copyright in the individual abstracts is owned by the author of each abstract or his/her employer unless otherwise stated. Each abstract, as well as the collection of abstracts, are published under a Creative Commons CC-BY 4.0 (attribution) licence (https://creativecommons.org/licenses/by/4.0/) and may thus be reproduced, translated, adapted and be the subject of derivative works provided the authors and Frontiers are attributed. For Frontiers’ terms and conditions please see https://www.frontiersin.org/legal/terms-and-conditions. Received: 27 Mar 2016; Published Online: 30 Mar 2016. Login Required This action requires you to be registered with Frontiers and logged in. To register or login click here. Abstract Info Abstract The Authors in Frontiers Kevin Mccabe Google Kevin Mccabe Google Scholar Kevin Mccabe PubMed Kevin Mccabe Related Article in Frontiers Google Scholar PubMed Abstract Close Back to top Javascript is disabled. Please enable Javascript in your browser settings in order to see all the content on this page.

Convective loading and release of latanoprost in silicone hydrogel contact lenses

Event Abstract Back to Event Convective loading and release of latanoprost in silicone hydrogel contact lenses William Pitt1, Ryan R. Horne1 and Kevin E. Judd1 1 Brigham Young University, Chemical Engineering Department, United States Statement of Purpose: We investigated the feasibility loading silicone hydrogel (SiHy) contact lenses with a hydrophobic anti-glaucoma drug, latanoprost, by swelling the lenses in a n-propanol solution of drug. Subsequent release into artificial tear solution (ATS) was measured. This study compares the loading and release of latanoprost in Acuvue Advance® (Johnson & Johnson Vision Care, Jacksonville, FL), Air Optix® (Alcon, Fort Worth, Texas) and Total Dailies 1® (Alcon). Methods: A 0.125 g/L n-propanol solution of radiolabeled latanoprost was made by dissolving latanoprost in n-propanol to which was added 5 µL of ethanol which contained 10 µCi of radioactive latanoprost. The loading procedure was performed at 25°C by removing a contact lens from its blister pack, rinsing with double-distilled water (DDH2O), blotting dry, immersing the contact lens in a loading solution for 240 seconds, immediately removing and washing the lens in 3 rinses for 5 seconds each in ~15 mL of DDH2O, and in ~5 mL of DDH2O for 15 minutes to allow for the lens to shrink to original size. The lens was moved either to a latanoprost extraction step or to ATS. Latanoprost extraction, a series of 2 soaks of 1 hr each in 2 mL n-propanol at 35°C, quantitated the radiolabeled latanoprost loaded into the lens, as described previously [1]. To simulating wear in ATS, the lens is immersed in 3 mL of ATS and swirled at 35°C. The lens was moved to fresh ATS after 1, 2, 4, and 6 days. A sample of ATS was taken for quantitation right before transferring the lens. Results: Latanoprost was successfully loaded into SiHy lenses. The drug showed 1st order release into artificial tears over a span of 2-3 days by which time the latanoprost was mostly depleted. For the same loading conditions, the amount of drug loaded and initial release rate were functions of the type of silicone hydrogel (see Figure 1). Of the lenses tested, Acuvue Advance® (galyfilcon A) accepted the most latanoprost and released at the fastest rates (p<0.05), followed by Air Optix® (lotrafilcon B) and Total Dailies 1® (delefilcon A) which released at similar rates. When normalized to the amount loaded, the kinetics of release of latanoprost were highly comparable for the different silicone hydrogels. Caption to Figure 1. Cumulative release of latanoprost per lens into ATS from different contact lenses . Error bars show the 95% CI, n=3. Conclusions: Literature reports of loading times for hydrophobic drugs are usually hours or days, [2] but this method allows for rapid loading of the drug latanoprost on the order of minutes. Despite a loading time of only 4 minutes, release is on the order of 2-4 days for the given conditions. We postulate that the hydrophobic character of SiHy contact lenses enables favorable interaction with the hydrophobic moieties of latanoprost, enhancing uptake during the loading process when latanoprost-solvating n-propanol in the polymer matrix is displaced by water, in which latanoprost is only minimally soluble. Loading and release was less for latanoprost than our previous findings for DMPC [1], which is consistent with latanoprost being less hydrophobic than DMPC. The amount of loading was higher in galyfilcon A which has 47% water content as compared to that of lotrafilcon B and delefilcon A, both having 33% water content. The higher loading is roughly correlated with the increase in water content of the polymer. Additional correlations of the silicone hydrogel chemistries and their potential effect on loading will also be presented. Funding for this study was provided by Brigham Young University.

CLAE to move to online format

CLAE to move to online format

The need for even further progress with clinical trial data sharing efforts: patients are waiting

The Johnson & Johnson vision for data sharing We believe in responsible sharing of clinical trial data that advances science and respects individual participants, who give their time and even take risks to contribute to medicine. In keeping with that belief, our company, Johnson & Johnson (NJ, USA), has established a data sharing agreement with the Yale Open Data Access Project, an independent academic institution, to review and decide, based on scientific merit, whether requests for access to our clinical trial data, for both pharmaceutical and medical device products, will be fulfilled [1]. Sharing clinical trial data has the potential to improve public health by providing a better understanding of physiology and pathophysiology, as well as both the benefits and risks of all types of treatments, including medicines and devices. Importantly, it also enables a powerful approach to address important questions that could not be addressed within individual studies by using either a combined analysis or metaanalysis, enabling a far deeper understanding of diseases, subgroups of patients who might respond differently and strengthening the evidence base for future studies, treatment guidelines, r egulatory, payer and medical decisions [2]. Recently, the Institute of Medicine released a comprehensive report, which offers recommendations for responsible data sharing and a vision of an ecosystem in which clinical trial data from all sources are more broadly accessible to the research community [3]. We support the Institute of Medicine’s recommendations and agree on the need to move forward, through multistakeholder groups, some of which are already working on various aspects of data transparency and approaches to harmonization, including the multiregional clinical trial forum [4] and TransCelerate [5]. We agree that the greatest value from data sharing efforts will only be realized if data sharing is agreed and embraced broadly. This will require all stakeholders who conduct clinical trials of all types and of all interventions to participate in data sharing, as well as an effort towards more common data collection tools and standards. Of course, all efforts have to be aimed at maintaining the highest possible scientific principles.

Design and analysis of Bayesian adaptive crossover trials for evaluating contact lens safety and efficacy.

A crossover study, also referred to as a crossover trial, is a form of longitudinal study. Subjects are randomly assigned to different arms of the study and receive different treatments sequentially. While there are many frequentist methods to analyze data from a crossover study, random effects models for longitudinal data are perhaps most naturally modeled within a Bayesian framework. In this article, we introduce a Bayesian adaptive approach to crossover studies for both efficacy and safety endpoints using Gibbs sampling. Using simulation, we find our approach can detect a true difference between two treatments with a specific false-positive rate that we can readily control via the standard equal-tail posterior credible interval. We then illustrate our Bayesian approaches using real data from Johnson & Johnson Vision Care, Inc. contact lens studies. We then design a variety of Bayesian adaptive predictive probability crossover studies for single and multiple continuous efficacy endpoints, indicate their extension to binary safety endpoints, and investigate their frequentist operating characteristics via simulation. The Bayesian adaptive approach emerges as a crossover trials tool that is useful yet surprisingly overlooked to date, particularly in contact lens development.