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Mark Packer Packer Research Associates, Boulder, CO, USACorrespondence: Mark Packer, Packer Research Associates, 1400 Bluebell Ave, Boulder, CO, 80302, USA, Tel +1 541 915 – 0291, Email mark@markpackerconsulting.comPurpose: To evaluate the safety and effectiveness of collamer posterior chamber phakic refractive lenses with a central port design (EVO and EVO+ Sphere and Toric implantable collamer lenses [ICLs]) for correction of moderate myopia with or without astigmatism.Patients and Methods: Six-month results of a multicenter clinical trial were performed under United States FDA Investigational Device Exemption. Subjects 21 through 45 years of age with manifest refraction spherical equivalent ranging from − 3.00 D to − 6.00 D and astigmatism up to 4.00 D underwent implantation of EVO or EVO+ Sphere or Toric ICLs. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, intraocular pressure (IOP), endothelial cell density, and adverse events were evaluated over 6 months.Results: This report includes a retrospective review of 200 eyes of 114 subjects with mean age 35.1 ± 5.1 years that completed the 6-month visit. Mean preoperative spherical equivalent (SE) measured − 4.61 ± 0.87 D (range: − 3.00 to − 6.00 D). At 6 months, mean SE was − 0.085 ± 0.26 D, with 91.5% within ± 0.50 D of target and 100.0% within ± 1.00 D of target. Mean postoperative UDVA and CDVA were − 0.065 ± 0.08 logMAR and − 0.14 ± 0.07 logMAR, respectively. About 98.0% of eyes maintained or gained lines of CDVA, and no eye lost more than 1 line CDVA. Efficacy and safety indices were 1.03 and 1.21, respectively. No eye experienced pupillary block, required preoperative or postoperative peripheral iridotomy or iridectomy, developed anterior subcapsular cataract or had elevated IOP due to angle narrowing or pigment dispersion. Mean endothelial cell density declined by 2.2%.Conclusion: EVO ICL lenses demonstrated accuracy, predictability and stability of refractive correction with achievement of high levels of UDVA and an excellent safety profile for patients with moderate myopia with or without astigmatism.Keywords: phakic refractive lens, moderate myopia, astigmatism, implantable collamer lens

Phillip J Buckhurst,1 George Lau,2 Jon I Williams,2 Mark Packer3 1School of Health Professions, University of Plymouth, Plymouth, UK; 2Bausch and Lomb Surgical, Bausch and Lomb Bridgewater, New Jersey, NJ, USA; 3Mark Packer Consulting, Boulder, CO, USACorrespondence: Phillip J Buckhurst, School of Health Professions, University of Plymouth, Plymouth, UK, Tel +44 1752 588884, Email Phillip.buckhurst@plymouth.ac.ukPurpose: To assess the refractive outcomes, intraocular centration and rotational stability of the enVista toric intraocular lens (IOL).Patients and Methods: This study was a prospective, multi-centre, double-masked, partially randomized and partially controlled clinical trial. A total of 191 participants were implanted with toric IOL (1.25, 2.00, or 2.75D) or non-toric IOL (control). The lowest range of corneal astigmatic eyes were randomized to 1.25D toric or control. Higher astigmatic powers were allocated to the treatment arm. Subjects were assessed immediately postoperatively, 1– 2 (V1), 7– 14 (V2), 30– 60 (V3) and 120– 180 (V4) days postoperatively. Unaided (UDVA) and distance corrected visual acuity (CDVA), manifest refraction and corneal curvature were assessed. Vector analysis was used to calculate surgically induced refractive correction (SIRC), correction ratio (CR), error magnitude (EM) and error vector (EV). Slit-lamp photography was used to measure centration and rotational stability.Results: UDVA was better in the low toric IOL group in comparison with the control group at V4 (p< 0.001). There was an undercorrection in the control group, whereas the average CR for all toric subjects was 1.00 ± 0.32: V2, 0.98 ± 0.34: V3 and 0.98 ± 0.35: V4. The absolute IOL rotational stability in comparison to the position of the IOL at V1 was 1.35° ± 0.97°: V2, 1.35° ± 1.07°: V3 and 1.38° ± 1.25°: V4. Decentration was generally inferior (V1: 0.04 ± 0.22mm, V2: 0.05± 0.20mm, V3: 0.08 ± 0.22mm, V4: 0.04 ± 0.21mm) and nasal (V1: 0.19 ± 0.23mm, V2: 0.20 ± 0.20mm, V3: 0.20 ± 0.21mm, V4: 0.17 ± 0.22mm).Conclusion: Participants with low levels of corneal astigmatism achieved superior vision and refractive outcomes in the low toric group over the control. Moderate and high levels of astigmatism achieved excellent refractive outcomes. The toric IOL demonstrated high levels of both rotational and centrational stability.Keywords: IOL, astigmatism, cataract, enVista, toric

Mark Packer Packer Research Associates, Boulder, CO, USACorrespondence: Mark Packer, Packer Research Associates, 1400 Bluebell Ave., Boulder, CO, 80302, USA, Tel +1 (541) 915 – 0291, Email mark@markpackerconsulting.comPurpose: To evaluate the safety and effectiveness of Collamer posterior chamber phakic refractive lenses with a central port design (EVO and EVO+ Sphere and Toric Visian ICLs) for correction of moderate-to-high myopia with or without astigmatism.Patients and Methods: Six-month results of a multicenter clinical trial performed under United States FDA Investigational Device Exemption. Subjects 21 through 45 years of age with myopia ranging from − 3.00 D to − 20.00 D and astigmatism up to 4.00 D underwent implantation of EVO or EVO+ Sphere or Toric Visian ICLs. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, intraocular pressure (IOP), endothelial cell density, and adverse events were evaluated over 6 months.Results: This clinical trial enrolled 629 eyes of 327 subjects with mean age 35.6 ± 5.09 years. Mean preoperative spherical equivalent (SE) measured − 7.62 ± 2.75 D (range: − 3.00 to − 15.62 D). At 6 months, mean SE was − 0.079 ± 0.33 D, with 90.5% within ± 0.50 D of target and 98.9% within ± 1.00 D of target. Mean postoperative UDVA and CDVA were − 0.059 ± 0.10 logMAR and − 0.13 ± 0.08 logMAR, respectively. 52.3% of eyes gained lines of CDVA. Efficacy and safety indices were 1.06 and 1.24, respectively. No eye experienced pupillary block, required peripheral iridotomy or iridectomy, developed anterior subcapsular cataract or had elevated IOP due to angle narrowing or pigment dispersion. Mean endothelial cell density declined by 2.3%.Conclusion: EVO ICL lenses demonstrated accuracy of refractive correction and achievement of high levels of UDVA. This clinical trial confirmed that the central port design of EVO and EVO+ Sphere and Toric Visian ICL lenses functions effectively to allow physiologic flow of aqueous humor, thus eliminating the requirement for preoperative peripheral iridotomies. The results of this clinical trial resulted in FDA approval on March 25, 2022.Keywords: phakic refractive lens, myopia, astigmatism, Implantable Collamer Lens

Mark Packer,1 Jose F Alfonso,2 Jaime Aramberri,3 Daniel Elies,4 Joaquin Fernandez,5 Erik Mertens6 1Packer Research Associates, Boulder, CO, USA; 2Ophthalmology Institute Fernández Vega, Oviedo, Asturias, Spain; 3Opthalmology Clinic Miranza Begitek, San Sebastian, Spain; 4Institute of Ocular Microsurgery, Barcelona, Spain; 5Qvision-Hospital Vithas Virgen del Mar, Almeria, Spain; 6Medipolis, Antwerp, BelgiumCorrespondence: Mark PackerPacker Research Associates, Boulder, CO, USATel +1 541 915 0291Email mark@markpackerconsulting.comPurpose: To evaluate the performance and safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) for improvement of uncorrected near, intermediate and distance visual acuity in phakic subjects with myopia and presbyopia.Design: Prospective multicenter study.Methods: Presbyopic subjects who required an EDOF ICL in the range of − 0.50 D to − 18.00 D, exhibited ≤ 0.75 D refractive astigmatism and required from +1.00 to +2.50 D reading add were implanted bilaterally. Assessments at 6 months included uncorrected near, intermediate and distance visual acuities, defocus curves, contrast sensitivity, responses to the National Eye Institute Refractive Error Quality of Life Questionnaire and a Task Assessment Questionnaire.Results: A total of 34 subjects completed the study. Investigators targeted emmetropia in all eyes. Mean binocular uncorrected near, intermediate and distance visual acuities measured logMAR − 0.01 ± 0.05 (20/20), − 0.02 ± 0.08 (20/19) and 0.07 ± 0.10 (20/23), respectively. Mean monocular uncorrected near, intermediate and distance visual acuities measured logMAR 0.068 ± 0.09 (20/23), 0.062 ± 0.10 (20/23) and 0.16 ± 0.12 (20/29). There were no clinically or statistically significant differences in contrast sensitivity between baseline and 6 months under any testing conditions. Subjects reported significant improvements in measures of vision-related quality of life and ability to perform tasks at all distances without glasses or contact lenses. Overall, satisfaction with the EDOF ICL was high: postoperatively, 91.2% of subjects were satisfied with their vision.Conclusion: This multicenter, prospective clinical investigation demonstrated the ability of the EDOF ICL to correct myopia and presbyopia, resulting in improvement of uncorrected near, intermediate and distance visual acuity without compromising the quality of vision. The EDOF ICL allowed subjects to perform tasks of daily living without glasses or contact lenses. Subjects reported significant improvements in quality of life with high levels of spectacle independence and satisfaction.Keywords: presbyopia, myopia, phakic refractive lens, implantable Collamer lens

© The Author 2014.Aims Although active-controlled trials with renin-angiotensin inhibitors are ethically mandated in heart failure with reduced ejection fraction, clinicians and regulators often want to know how the experimental therapy would perform compa

Mark Packer Mark Packer MD Consulting, Inc., Boulder, CO, USA Abstract: The purpose of this review is to summarize preclinical and clinical data from publications appearing in the peer-reviewed scientific literature relevant to the safety and effectiveness of the EVO Implantable Collamer Lens (ICL) posterior chamber phakic refractive lens with a central port (V4c Visian ICL with KS Aquaport, STAAR Surgical, Inc.). A literature search was conducted using PubMed.gov to identify all articles relating to the EVO ICL. Articles were examined for their relevance, and the references cited in each article were also searched for additional relevant publications. On the basis of a total of 67 preclinical studies and clinical reports, including effectiveness data on 1,905 eyes with average weighted follow-up of 12.5 months and safety data on 4,196 eyes with weighted average follow up of 14.0 months, the EVO ICL is safe and effective for the correction of a broad range of refractive errors. High levels of postoperative uncorrected visual acuity, refractive predictability, and stability demonstrate the effectiveness of the EVO ICL. Safety data suggest reduced rates of anterior subcapsular cataract and pupillary block compared with earlier models. Improved safety and proven effectiveness make EVO an attractive option for surgeons and patients. Keywords: myopia, astigmatism, hyperopia, phakic refractive lens

Magnetically sensitive experiments and newly developed quantum technologies with integrated high-permeability magnetic shields require increasing control of their magnetic field environment and reductions in size, weight, power, and cost. However, magnetic fields generated by active components are distorted by high-permeability magnetic shielding, particularly when they are close to the shield's surface. Here, we present an efficient design methodology for creating desired static magnetic field profiles by using discrete coils electromagnetically coupled to a cylindrical passive magnetic shield. We utilize a modified Green's function solution that accounts for the interior boundary conditions on a closed finite-length high-permeability cylindrical magnetic shield and determine simplified expressions when a cylindrical coil approaches the interior surface of the shield. We use an analytic formulation of simple discrete building blocks to provide a complete discrete coil basis to generate any physically attainable magnetic field inside the shield. We then use a genetic algorithm to find optimized discrete coil structures composed of this basis. We use our methodology to generate an improved linear axial gradient field, d B z / d z , and a transverse bias field, B x. These optimized structures generate the desired fields with less than 1 % error in volumes seven and three times greater in spatial extent than equivalent unoptimized standard configurations. This coil design method can be used to optimize active–passive magnetic field shaping systems that are compact and simple to manufacture, enabling accurate control of magnetic field changes in spatially confined experiments at low cost. [ABSTRACT FROM AUTHOR]

Mark Packer,1 Jon I Williams,2 Gregg Feinerman,3 Richard S Hope2 On behalf of the enVista Toric Clinical Study Group 1Mark Packer MD Consulting, Inc., Boulder, CO, USA; 2Surgical Clinical and Medical Affairs, Bausch & Lomb Inc., Irvine, CA, USA; 3Feinerman Vision Center, Newport Beach, CA, USA Purpose: Glistening formation in the intraocular lens (IOL) optic has the potential to impact quality of vision. The enVista One-Piece Hydrophobic Acrylic Spherical IOL Model MX60 (MX60 IOL) is currently the only US Food and Drug Administration-approved IOL with a label of “no glistenings”. The purpose of this prospective, multicenter, partially randomized, partially controlled, double-masked, pivotal study was to evaluate the safety and effectiveness of the enVista One-Piece Hydrophobic Acrylic MX60T Toric IOL (enVista MX60T Toric IOL). Patients and methods: Subjects (n=191) were implanted with the enVista MX60T Toric IOL (cylinder powers 1.25, 2.00, or 2.75 D) or the parent MX60 IOL (control). Eyes within the lowest range of corneal astigmatism were randomized to receive either Toric 1.25 D IOL or control IOL in a 1:1 ratio. All subjects with corneal astigmatism requiring 2.00 or 2.75 D cylinder IOLs received toric IOLs. Rotational stability, cylinder reduction, and best-corrected distance visual acuity were primary effectiveness endpoints measured at Visit 4 (120–180 days postoperatively). Results: Visit 4 mean absolute axis misalignment in the All Toric group was 4.68°±7.33°, and all subjects had ≤5° absolute rotation from Visit 3 to Visit 4. The 1.25 D group had significantly greater improvement in dioptric cylinder reduction (P

Mark Packer Mark Packer MD Consulting, Inc., Boulder, CO, USA Abstract: The purpose of this review is to summarize relevant data from publications appearing in the peer-reviewed scientific literature over the past decade since US Food and Drug Administration approval of the implantable collamer lens (ICL), and, in particular, to review studies relating to sizing methodology, safety, and effectiveness, as well as more recent studies reporting clinical outcomes of the V4c Visian ICL with KS Aquaport, VICMO. A literature search was conducted using two databases, PubMed.gov and Science.gov, to identify all articles published after 2005 related to the Visian ICL (STAAR Surgical, Inc.). Articles were examined for their relevance to sizing methodology, clinical safety, and effectiveness, and the references cited in each article were also searched for additional relevant publications. The literature review revealed that all currently reported methods of determining the best-fit size of the ICL achieve similarly satisfactory results in terms of vault, the safe distance between the crystalline lens and the ICL. Specifically, meta-analysis demonstrated that sulcus-to-sulcus and white-to-white measurement-based sizing methods do not result in clinically meaningful nor statistically significant differences in vault (two-sample two-sided t-test using pooled mean and standard deviations; t (2,594)=1.33; P=0.18). The reported rates of complications related to vault are very low, except in two case series where additional risk factors such as higher levels of myopia and older age impacted the incidence of cataract. On the basis of preclinical studies and initial clinical reports, with up to 5 years of follow-up, the new VICMO central port design holds promise for further reduction of complications. Given its safety record and the significant improvement in vision and quality of life that the ICL makes possible, the benefits of ICL implantation outweigh the risks. Keywords: refractive surgery, Phakic lens, posterior chamber, myopia

Mark Packer,1 Mohan Rajan,2 Edoardo Ligabue,3 Peter Heiner4 1Oregon Health and Science University, Portland, OR, USA; 2Rajan Eye Care Hospital Pvt Ltd, Chennai, India; 3Ophthalmology Department, Centro Diagnostico Italiano, Milan, Italy; 4Bond University Medical School, Robina, QLD, Australia Abstract: A new, single-piece, hydrophobic acrylic lens – the first constructed with a lens optic and haptics comprised of a hydroxyethyl methacrylate-polyethylene glycol phenyl ether acrylate–styrene copolymer, cross-linked with ethylene glycol dimethacrylate, and labeled as "glistening-free" – was recently introduced globally. Glistenings have been a significant source of clinical concern with previous hydrophobic lens designs. This new monofocal lens provides enhanced, clear optics for lens-based surgery. The superior optical clarity of this lens is achieved through the elimination of glistenings, enhanced surface durability, high refractive index, a high Abbe number, and an aspheric design. Additionally, the lens design reduces the risk of developing posterior capsule opacification. Keywords: glistenings, monofocal hydrophobic acrylic, IOL, aspheric

Mark Packer,1 Luther Fry,2 Kevin T Lavery,3 Robert Lehmann,4 James McDonald,5 Louis Nichamin,6 Brian Bearie,7,† Jon Hayashida,8 Griffith E Altmann,8 Omid Khodai8 1Department of Ophthalmology, Oregon Health and Science University, Eugene, OR, USA; 2University of Kansas Medical Center, Kansas City, KS, USA; 3Wayne State University, Detroit, MI, USA; 4Baylor College of Medicine, Houston, TX, USA; 5University of Arkansas for Medical Sciences, Little Rock, AR, USA; 6Laurel Eye Clinic, Brookville, PA, USA; 7Grand Rapids Eye Institute, Grand Rapids, MI, USA; 8Bausch & Lomb, Aliso Viejo, CA, USA †Brian Bearie passed away on March 9, 2011 Purpose: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL; enVista model MX60; Bausch & Lomb, Rochester, NY, USA) when used to correct aphakia following cataract extraction in adults. Methods: This was a prospective case series (NCT01230060) conducted in private practices in the US. Eligible subjects were adult patients with age-related cataract amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. With follow-up of 6 months, primary safety and effectiveness end points included the rates of US Food and Drug Administration (FDA)-defined cumulative and persistent adverse events and the percentage of subjects who achieved best-corrected visual acuity (BCVA) of 20/40 or better at final visit. To evaluate rotational stability, subjects were randomized (1:1:1:1) to have the lens implanted in one of four axis positions in 45° increments. Results: A total of 122 subjects were enrolled. The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance. At the final postoperative visit, all subjects (100%) achieved a BCVA of 20/40 compared with the FDA historical control of 96.7%. Rotation of the IOL between the two final follow-up visits was ≤5° for 100% of eyes, and refractive stability was demonstrated. A low evaluation of posterior capsule opacification score was demonstrated, and no glistenings of any grade were reported for any subject at any visit. Conclusion: This study demonstrated the safety and effectiveness of the MX60 IOL. Favorable clinical outcomes included preserved BCVA, excellent rotational and refractive stability, no glistenings, and a low evaluation of posterior capsule opacification score. Keywords: cataract surgery, enVista, glistenings, intraocular lens, hydrophobic acrylic

Sara Misra, Blánaid Daly, Stephen Dunne, Brian Millar, Mark Packer, Koula AsimakopoulouDental Institute, King's College London, London, UKBackground: There is a lack of information about the extent to which patients recall key facts of dental consultations. Forgetting health advice undermines adherence with such instructions and is a potential problem. This study assessed the quantity and type of information recalled in a dental consultation, dentist–patient agreement over the contents of the consultation, and the relationship of such recall with patient satisfaction.Methods: Using a cross-sectional design, questionnaire data were obtained from patients recruited through a letter and presenting for a routine dental consultation. General issues discussed, specific information about oral health given, dentist-performed procedures, and agreed future actions were reported independently in writing, by patients and also by the treating dentist immediately postconsultation. Additionally, patients completed a dental visit satisfaction questionnaire.Results: Responses (n = 26, 55% response rate) were content-analyzed, and data on the number and type of information that was recalled were obtained. Interrater reliability was established. Inferential testing showed differences in dentist–patient recall, dentist–patient agreement, and the association between patient recall and satisfaction. Dentists recalled more information than patients (P = 0.001). Dentists further reported giving more dental health education (P = 0.006) and discussing more future actions (P = 0.002) than patients actually remembered. Technical (eg, crowns/bridges) rather than psychosocial (eg, pain/embarrassment) issues were reported more often (P = 0.001) by both dentists and patients. Dentist–patient agreement over issues discussed and procedures performed was higher (kappa = 0.210–0.310) than dental health education agreement and agreed future actions (kappa = 0.060–0.110). There was no relationship between patient recall and patient satisfaction with the consultation (P = 0.240).Conclusion: Patients do not recall as much advice and agreed actions about future dental care as dentists believe they have discussed. These results have implications for patient adherence with oral health instructions.Keywords: patient memory, dental consultation, patient satisfaction