Publications by authors named "Mark Packer"

114 Publications

Accuracy and safety of partial thickness femtosecond laser radial and arcuate keratotomy incisions in porcine eyes.

Eye Vis (Lond) 2021 Dec 1;8(1):41. Epub 2021 Dec 1.

Packer Research Associates, Inc., 1400 Bluebell Ave., Boulder, CO, 80302, USA.

Background: To evaluate the accuracy and safety of micro radial and arcuate keratotomy incisions constructed by a femtosecond laser system with a curved contact patient interface in porcine eyes.

Methods: Partial thickness micro radial and arcuate keratotomy incisions were constructed in porcine eyes with a femtosecond laser system and evaluated for precision of depth, quality, and consistency. Optical coherence tomography was used to determine the accuracy and precision of incision depth. Corneal endothelial safety was assessed by a fluorescent live/dead cell viability assay to demonstrate laser-induced endothelial cell loss. Quality was evaluated by ease of opening and examination of interfaces.

Results: In two micro radial incision groups, intended incision depths of 50% and 80% resulted in mean achieved depths of 50.01% and 77.69%, respectively. In three arcuate incision groups, intended incision depths of 80%, 600 μm or 100 μm residual uncut bed thickness resulted in mean achieved depths of 80.16%, 603.03 μm and residual bed of 115 μm, respectively. No loss of endothelial cell density occurred when the residual corneal bed was maintained at a minimum of 85-116 µm. The incisions were easy to open, and interfaces were smooth.

Conclusions: A femtosecond laser system with curved contact interface created precise and reproducible micro radial and arcuate keratotomy incisions. Accuracy and precision of the incision depth and preservation of endothelial cell density demonstrated the effectiveness and safety of the system.
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http://dx.doi.org/10.1186/s40662-021-00268-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8638553PMC
December 2021

Performance and Safety of the Extended Depth of Focus Implantable Collamer Lens (EDOF ICL) in Phakic Subjects with Presbyopia.

Clin Ophthalmol 2020 18;14:2717-2730. Epub 2020 Sep 18.

Medipolis, Antwerp, Belgium.

Purpose: 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.
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http://dx.doi.org/10.2147/OPTH.S271858DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7509320PMC
September 2020

Femtosecond laser-assisted arcuate keratotomy at the time of cataract surgery for the management of preexisting astigmatism.

J Cataract Refract Surg 2019 12;45(12):1762-1769

Mark Packer MD Consulting, Inc., Boulder, Colorado, USA. Electronic address:

Purpose: To evaluate the outcomes of femtosecond laser-assisted arcuate keratotomy combined with cataract surgery in eyes with low-to-moderate corneal astigmatism.

Setting: Eyes of York Private Practice Ophthalmology Clinic, York, Pennsylvania, USA.

Design: Retrospective case series.

Methods: This retrospective analysis included case records of patients with preexisting corneal astigmatism ranging from 0.5 to 2.0 diopter (D). Study parameters included corneal astigmatism, refractive astigmatism, and uncorrected (UDVA) and corrected (CDVA) distance visual acuities. The results, which were analyzed at 3 months postoperatively, included frequency distribution histograms, vector analysis, and single-angle polar plots.

Results: The study comprised case records of 189 eyes of 143 patients (56 men and 87 women). The postoperative refractive astigmatism was reduced significantly compared with preoperative corneal astigmatism to 0.14 D ± 0.23 (SD) from 0.92 ± 0.34 D (P < .001). One hundred eighty-one eyes (95.8%) demonstrated postoperative refractive astigmatism of 0.5 D or less. The mean surgically induced change along the preoperative steep axis was -0.59 ± 0.56 D, and the change along the orthogonal axis was 0.01 ± 0.35 D. Postoperatively, 171 eyes (90.5%) had astigmatism angle of error of 15 degrees or less. The postoperative mean UDVA and CDVA were 0.09 ± 0.16 logarithm of the minimum angle of resolution (logMAR) and 0.02 ± 0.05 logMAR, respectively. One hundred seventy eyes (90%) had a postoperative UDVA of 20/30 or better. The results demonstrated stability at 12 months postoperatively. No intraoperative or postoperative arcuate keratotomy-related events were observed.

Conclusion: The results suggest that femtosecond laser-assisted arcuate keratotomy represents a safe and effective method for astigmatism correction at the time of cataract surgery with demonstrated stability of correction for at least 1 year postoperatively.
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http://dx.doi.org/10.1016/j.jcrs.2019.08.002DOI Listing
December 2019

Femtosecond laser-assisted capsulotomy with capsular marks for toric IOL alignment: Comparison of tensile strength with standard femtosecond laser capsulotomy.

J Cataract Refract Surg 2019 08 2;45(8):1177-1182. Epub 2019 Jul 2.

Mark Packer MD Consulting, Inc., Boulder, Colorado, USA. Electronic address:

Purpose: To compare the capsulotomy rim strength with capsular marks (CMs) to the rim strength without CMs in porcine eyes, and to demonstrate the practicality of CMs for intraoperative toric intraocular lens (IOL) alignment.

Setting: LENSAR facility, Orlando, Florida, USA.

Design: Laboratory study.

Methods: The biomechanical strength of the capsulotomy with CMs was tested under two different load orientations (orthogonal to or in-line with CMs). Thirty-six porcine eyes were randomly assigned to three treatment cohorts: (1) standard capsulotomy with no CMs, (2) capsulotomy with CMs for in-line tensile testing and (3) capsulotomy with CMs for orthogonal tensile testing. Study parameters were capsulotomy break force and maximum extensibility. The ease of using CMs for toric IOL alignment was also evaluated.

Results: There was no significant difference between the mean break force for standard capsulotomy (180.57 mN ± 22 [SD]), capsulotomy with CMs with orthogonal load (178.04 ± 20 mN, P = 1.000), and with in-line load (181.05 ± 15 mN, P = 1.000). Likewise, the mean extensibility at the break point for standard capsulotomy (6.47 ± 0.33 mm) was equivalent to the mean extensibility with CMs with orthogonal load (6.49 ± 0.45 mm, P = 1.000) and with in-line load (6.3 ± 0.47 mm, P = .960). In the implanted eyes, toric IOLs were found to be easily aligned with the CMs.

Conclusion: The femtosecond laser capsulotomies with CMs were equivalent in tensile strength and extensibility to standard femtosecond laser capsulotomies and showed high potential for effective alignment of toric IOLs.
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http://dx.doi.org/10.1016/j.jcrs.2019.03.021DOI Listing
August 2019

Query regarding rate of complications with Implantable Collamer Lens.

Authors:
Mark Packer

J Curr Ophthalmol 2019 Mar 2;31(1):113. Epub 2018 Nov 2.

Mark Packer MD Consulting, Inc., Boulder, CO, USA.

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http://dx.doi.org/10.1016/j.joco.2018.10.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6407148PMC
March 2019

Comment on "A case of hypermature cataract formation following implantation of an implantable collamer lens with an Aquaport".

Authors:
Mark Packer

Int J Ophthalmol 2019 18;12(1):178. Epub 2019 Jan 18.

Mark Packer MD Consulting, Inc., Boulder, CO 80302, United States.

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http://dx.doi.org/10.18240/ijo.2019.01.28DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6326944PMC
January 2019

The Implantable Collamer Lens with a central port: review of the literature.

Authors:
Mark Packer

Clin Ophthalmol 2018 27;12:2427-2438. Epub 2018 Nov 27.

Mark Packer MD Consulting, Inc., Boulder, CO, USA,

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.
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http://dx.doi.org/10.2147/OPTH.S188785DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6267497PMC
November 2018

A review of the outcome of dental implant provision in individuals with movement disorders.

Eur J Oral Implantol 2018 ;11 Suppl 1:S47-S63

Movement disorders encompass a wide range of medical conditions that demonstrate changes to muscle function and tone which present with orofacial dyskinesia and dystonia. The most common conditions exhibiting these features are Parkinson's disease, Down syndrome, chorea and epilepsy.

Aim: To establish whether implant success in patients suffering from movement disorders is similar to the general population, identifying risk factors and noting recommendations that may aid maintenance programmes.

Method: PubMed and Medline searches, combined with a manual search of the reference lists of identified full text studies. In total, 19 patient case reports and 11 patient case series were identified for inclusion in the review.

Results: Implant survival in patients may be less than expected in patients with movement disorders, but evidence points to early rather than late failures. Oral hygiene control was widely reported as an issue, although there was insufficient evidence to imply that a lack of oral care will cause more rapid deterioration in implant patients with movement disorders. Maintenance requirements were low for fixed restorations, but more frequently reported in patients treated with overdentures, with the attachment mechanism and the prostheses requiring replacement. Chewing and quality of life in relation to prosthesis wear were improved.

Conclusion: Provision of implant-supported prostheses improves chewing and quality of life for patients with movement disorders and should be considered as an option in the treatment planning for tooth loss in this group of patients. However, straightforward designs that lend themselves to easier long-term maintenance should be adopted.
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March 2020

Prospective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens.

Clin Ophthalmol 2018 1;12:1031-1039. Epub 2018 Jun 1.

Surgical Clinical and Medical Affairs, Bausch & Lomb Inc., Irvine, 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 (<0.001), percent cylinder reduction (<0.001), and mean uncorrected distance visual acuity (<0.001), compared to control at Visit 4. Most adverse events (AEs) were mild, with no serious AEs in the study eyes. The rates of cumulative AEs through Visit 4 were below International Organization for Standardization (ISO) standard 11979-7 AE rates.

Conclusion: enVista MX60T Toric IOL is safe and effective for patients with preoperative corneal astigmatism undergoing IOL implantation.
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http://dx.doi.org/10.2147/OPTH.S167726DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5987786PMC
June 2018

Comparison of Wound Sealability Between Femtosecond Laser-Constructed and Manual Clear Corneal Incisions in Patients Undergoing Cataract Surgery: A Pilot Study.

J Refract Surg 2017 Nov;33(11):744-748

Purpose: To compare the sealability of femtosecond laser-constructed and manual clear corneal incisions (CCIs) in patients undergoing cataract surgery.

Methods: This prospective, randomized study included 62 eyes of 62 patients with cataract grade 1 to 2 (LOCS scale). The patients were randomly assigned (1:1) for creation of either manual CCI (with a 2.4-mm keratome) or femtosecond laser-assisted CCI (LENSAR, Inc., Orlando, FL) (31 eyes in each group) before undergoing femtosecond laser-assisted cataract surgery. Wound sealability was assessed as grade 1, 2, or 3 (1: need to reform anterior chamber and hydrate wound at end of surgery; 2: need to reform anterior chamber only; 3: formed anterior chamber, no hydration or anterior chamber reformation necessary).

Results: The nuclear sclerosis grade, cumulative dissipated energy and phacoemulsification time were comparable between the two groups. No complications were experienced in any of the patients. The mean wound sealability for the femtosecond laser group (2.35 ± 0.84) was statistically significantly better in comparison to the manual group (1.32 ± 0.65) (P < .001). At the end of the surgery, 22.6% (n = 7) of eyes in the femtosecond laser group needed reformation of the anterior chamber and hydration of the wound compared to 77.4% (n = 24) of eyes in the manual group. Conversely, 58.1% (n = 18) of eyes in the femtosecond laser group compared to 9.7% (n = 3) of eyes in the manual group were observed to have a formed anterior chamber.

Conclusions: Femtosecond laser-created CCIs had significantly better wound sealability compared to those created with a metal keratome. [J Refract Surg. 2017;33(11):744-748.].
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http://dx.doi.org/10.3928/1081597X-20170921-01DOI Listing
November 2017

The Biological Basis of Chronic Traumatic Encephalopathy following Blast Injury: A Literature Review.

J Neurotrauma 2017 09;34(S1):S26-S43

25 Program Executive Office Soldier , Fort Belvoir, Virginia.

The United States Department of Defense Blast Injury Research Program Coordinating Office organized the 2015 International State-of-the-Science meeting to explore links between blast-related head injury and the development of chronic traumatic encephalopathy (CTE). Before the meeting, the planning committee examined articles published between 2005 and October 2015 and prepared this literature review, which summarized broadly CTE research and addressed questions about the pathophysiological basis of CTE and its relationship to blast- and nonblast-related head injury. It served to inform participants objectively and help focus meeting discussion on identifying knowledge gaps and priority research areas. CTE is described generally as a progressive neurodegenerative disorder affecting persons exposed to head injury. Affected individuals have been participants primarily in contact sports and military personnel, some of whom were exposed to blast. The symptomatology of CTE overlaps with Alzheimer's disease and includes neurological and cognitive deficits, psychiatric and behavioral problems, and dementia. There are no validated diagnostic criteria, and neuropathological evidence of CTE has come exclusively from autopsy examination of subjects with histories of exposure to head injury. The perivascular accumulation of hyperphosphorylated tau (p-tau) at the depths of cortical sulci is thought to be unique to CTE and has been proposed as a diagnostic requirement, although the contribution of p-tau and other reported pathologies to the development of clinical symptoms of CTE are unknown. The literature on CTE is limited and is focused predominantly on head injuries unrelated to blast exposure (e.g., football players and boxers). In addition, comparative analyses of clinical case reports has been challenging because of small case numbers, selection biases, methodological differences, and lack of matched controls, particularly for blast-exposed individuals. Consequently, the existing literature is not sufficient to determine whether the development of CTE is associated with head injury frequency (e.g., single vs. multiple exposures) or head injury type (e.g., impact, nonimpact, blast-related). Moreover, the incidence and prevalence of CTE in at-risk populations is unknown. Future research priorities should include identifying additional risk factors, pursuing population-based longitudinal studies, and developing the ability to detect and diagnose CTE in living persons using validated criteria.
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http://dx.doi.org/10.1089/neu.2017.5218DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5695742PMC
September 2017

Editorial: Auditory injury - A military perspective.

Hear Res 2017 06;349:1-3

St. Jude Children's Research Hospital, USA. Electronic address:

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http://dx.doi.org/10.1016/j.heares.2017.04.010DOI Listing
June 2017

Analytical and numerical modeling of the hearing system: Advances towards the assessment of hearing damage.

Hear Res 2017 06 2;349:111-128. Epub 2017 Feb 2.

Department of Biomedical Engineering, Grove School of Engineering of the City College and, The Graduate School of the City University of New York, New York, NY 10031, United States. Electronic address:

Hearing is an extremely complex phenomenon, involving a large number of interrelated variables that are difficult to measure in vivo. In order to investigate such process under simplified and well-controlled conditions, models of sound transmission have been developed through many decades of research. The value of modeling the hearing system is not only to explain the normal function of the hearing system and account for experimental and clinical observations, but to simulate a variety of pathological conditions that lead to hearing damage and hearing loss, as well as for development of auditory implants, effective ear protections and auditory hazard countermeasures. In this paper, we provide a review of the strategies used to model the auditory function of the external, middle, inner ear, and the micromechanics of the organ of Corti, along with some of the key results obtained from such modeling efforts. Recent analytical and numerical approaches have incorporated the nonlinear behavior of some parameters and structures into their models. Few models of the integrated hearing system exist; in particular, we describe the evolution of the Auditory Hazard Assessment Algorithm for Human (AHAAH) model, used for prediction of hearing damage due to high intensity sound pressure. Unlike the AHAAH model, 3D finite element models of the entire hearing system are not able yet to predict auditory risk and threshold shifts. It is expected that both AHAAH and FE models will evolve towards a more accurate assessment of threshold shifts and hearing loss under a variety of stimuli conditions and pathologies.
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http://dx.doi.org/10.1016/j.heares.2017.01.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7000179PMC
June 2017

Reply.

Ophthalmology 2017 01;124(1):e12

Oregon Health & Science University, Portland, Oregon.

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http://dx.doi.org/10.1016/j.ophtha.2016.05.010DOI Listing
January 2017

Endophthalmitis Prophylaxis in Cataract Surgery: Overview of Current Practice Patterns Around the World.

Curr Pharm Des 2017 ;23(4):565-573

Umea University, Umea. Sweden.

Background: Acute-onset postoperative endophthalmitis after cataract surgery remains a rare but important cause of visual loss. There is no global consensus regarding the optimal strategies for prophylaxis of endophthalmitis and practices vary substantially around the world, especially with respect to the use of intracameral antibiotics. The European Society of Cataract & Refractive Surgeons in a randomized clinical trial (2007) reported an approximately 5-fold reduction in endophthalmitis rates associated with the use of intracameral cefuroxime. Despite this report, the use of intracameral antibiotics has not been universally adopted.

Methods: Various endophthalmitis prophylaxis patterns around the world (including the United States, Canada, Australia/New Zealand, Japan, China, India, Indonesia, South Africa, Argentina, Russia, Sweden and Mexico) are compared. Each contributing author was asked to provide similar information, including endophthalmitis rates based on published studies, current practice patterns, and in some cases original survey data. Various methods were used to obtain this information, including literature reviews, expert commentary, and some new survey data not previously published.

Results: Many different practice patterns were reported from around the world, specifically with respect to the use of intracameral antibiotics.

Conclusion: There is no worldwide consensus regarding endophthalmitis prophylaxis with cataract surgery.
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http://dx.doi.org/10.2174/1381612822666161216122230DOI Listing
December 2017

Human cochlear hydrodynamics: A high-resolution μCT-based finite element study.

J Biomech 2017 01 10;50:209-216. Epub 2016 Nov 10.

The Department of Biomedical Engineering, Grove School of Engineering of The City College and The Graduate School of The City University of New York, New York, NY 10031, USA. Electronic address:

Measurements of perilymph hydrodynamics in the human cochlea are scarce, being mostly limited to the fluid pressure at the basal or apical turn of the scalae vestibuli and tympani. Indeed, measurements of fluid pressure or volumetric flow rate have only been reported in animal models. In this study we imaged the human ear at 6.7 and 3-µm resolution using µCT scanning to produce highly accurate 3D models of the entire ear and particularly the cochlea scalae. We used a contrast agent to better distinguish soft from hard tissues, including the auditory canal, tympanic membrane, malleus, incus, stapes, ligaments, oval and round window, scalae vestibule and tympani. Using a Computational Fluid Dynamics (CFD) approach and this anatomically correct 3D model of the human cochlea, we examined the pressure and perilymph flow velocity as a function of location, time and frequency within the auditory range. Perimeter, surface, hydraulic diameter, Womersley and Reynolds numbers were computed every 45° of rotation around the central axis of the cochlear spiral. CFD results showed both spatial and temporal pressure gradients along the cochlea. Small Reynolds number and large Womersley values indicate that the perilymph fluid flow at auditory frequencies is laminar and its velocity profile is plug-like. The pressure was found 102-106° out of phase with the fluid flow velocity at the scalae vestibule and tympani, respectively. The average flow velocity was found in the sub-µm/s to nm/s range at 20-100Hz, and below the nm/s range at 1-20kHz.
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http://dx.doi.org/10.1016/j.jbiomech.2016.11.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5292244PMC
January 2017

Pharmacodynamic profile of mydriatic agents delivered by ocular piezo-ejection microdosing compared with conventional eyedropper.

Ther Deliv 2016 11 13;7(11):751-760. Epub 2016 Oct 13.

Department of Ophthalmology, Hamilton Glaucoma Center & Shiley Eye Institute, University of California at San Diego, CA, USA.

Aim: Eyedroppers deliver medication volumes exceeding conjunctival absorptive capacity, causing spillage and risking ocular/systemic complications. We evaluated piezoelectric microdosing. Results/methodology: Subjects (n = 102) received precision microdroplet delivery of phenylephrine (2.5%) and tropicamide (1.0%): 1 × 1.5 μl, 1 × 6 μl or 2 × 3 μl of each (randomized 1:1:1), into one eye. Contralateral eyes received eyedropper doses of both drugs. Outcomes were pupil dilation (0-60 min) and patient satisfaction. Six-microliter microdosing achieved comparable, and 2 × 3 μl met/exceeded dilation speed and magnitude versus eyedropper. Separately, participants preferred piezoelectric saline self-delivery to eyedroppers, reporting better head-positioning comfort, reduced tearing/overflow and increased likelihood of adhering to ocular medication regimens.

Conclusion: Piezoelectric microdosing achieves comparable effects as eyedroppers delivering 4-17-fold larger doses. Microdosing may enhance patient adherence to ocular medication regimens while minimizing side effects.
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http://dx.doi.org/10.4155/tde-2016-0061DOI Listing
November 2016

Introduction to the Pharmaceutical Interventions for Hearing Loss Clinical Research Guidance Papers.

Otol Neurotol 2016 09;37(8):e261-2

DOD Hearing Center of Excellence, JBSA Lackland, TX.

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http://dx.doi.org/10.1097/MAO.0000000000001155DOI Listing
September 2016

Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts.

Ophthalmology 2016 10 6;123(10):2103-12. Epub 2016 Aug 6.

Transcend Medical, Inc., Menlo Park, California; University of California-San Francisco, San Francisco, California. Electronic address:

Purpose: We evaluated 2-year safety and efficacy of supraciliary microstenting (CyPass Micro-Stent; Transcend Medical, Inc., Menlo Park, CA) for treating mild-to-moderate primary open-angle glaucoma (POAG) in patients undergoing cataract surgery.

Design: Multicenter (24 US sites), interventional randomized clinical trial (RCT) (ClinicalTrials.gov identifier, NCT01085357).

Participants: Subjects were enrolled beginning July 2011, with study completion in March 2015. Subjects had POAG with mean diurnal unmedicated intraocular pressure (IOP) 21-33 mmHg and were undergoing phacoemulsification cataract surgery.

Methods: After completing cataract surgery, subjects were intraoperatively randomized to phacoemulsification only (control) or supraciliary microstenting with phacoemulsification (microstent) groups (1:3 ratio). Microstent implantation via an ab interno approach to the supraciliary space allowed concomitant cataract and glaucoma surgery.

Main Outcome Measures: Outcome measures included percentage of subjects achieving ≥20% unmedicated diurnal IOP lowering versus baseline, mean IOP change and glaucoma medication use, and ocular adverse event (AE) incidence through 24 months.

Results: Of 505 subjects, 131 were randomized to the control group and 374 were randomized to the microstent group. Baseline mean IOPs in the control and microstent groups were similar: 24.5±3.0 and 24.4±2.8 mmHg, respectively (P > 0.05); mean medications were 1.3±1.0 and 1.4±0.9, respectively (P > 0.05). There was early and sustained IOP reduction, with 60% of controls versus 77% of microstent subjects achieving ≥20% unmedicated IOP lowering versus baseline at 24 months (P = 0.001; per-protocol analysis). Mean IOP reduction was ↓7.4 mmHg for the microstent group versus ↓5.4 mmHg in controls (P < 0.001), with 85% of microstent subjects not requiring IOP medications at 24 months. Mean 24-month medication use was 67% lower in microstent subjects (P < 0.001); 59% of control versus 85% of microstent subjects were medication free. Mean medication use in controls decreased from 1.3±1.0 drugs at baseline to 0.7±0.9 and 0.6±0.8 drugs at 12 and 24 months, respectively, and in the microstent group from 1.4±0.9 to 0.2±0.6 drugs at both 12 and 24 months (P < 0.001 for reductions in both groups at both follow-ups vs. baseline). No vision-threatening microstent-related AEs occurred. Visual acuity was high in both groups through 24 months; >98% of all subjects achieved 20/40 best-corrected visual acuity or better.

Conclusions: This RCT demonstrated safe and sustained 2-year reduction in IOP and glaucoma medication use after microinterventional surgical treatment for mild-to-moderate POAG.
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http://dx.doi.org/10.1016/j.ophtha.2016.06.032DOI Listing
October 2016

Meta-analysis and review: effectiveness, safety, and central port design of the intraocular collamer lens.

Authors:
Mark Packer

Clin Ophthalmol 2016 9;10:1059-77. Epub 2016 Jun 9.

Mark Packer MD Consulting, Inc., Boulder, CO, USA.

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.
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http://dx.doi.org/10.2147/OPTH.S111620DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4907705PMC
June 2016

The impact of hearing impairment and noise-induced hearing injury on quality of life in the active-duty military population: challenges to the study of this issue.

Mil Med Res 2016 12;3:11. Epub 2016 Apr 12.

Department of Defense Hearing Center of Excellence, 59MDW/SG02O, 2200 Bergquist Drive, Suite 1, JBSA Lackland, TX 78236 USA.

The objectives of this research were to 1) summarize the available evidence on the impact of hearing loss on quality of life (QOL) among U.S. active-duty service members, 2) describe the QOL instruments that have been used to quantify the impact of hearing loss on quality of life, 3) examine national population-level secondary databases and report on their utility for studying the impact of hearing loss on QOL among active-duty service members, and 4) provide recommendations for future studies that seek to quantify the impact of hearing loss in this population. There is a lack of literature that addresses the intersection of hearing impairment, the military population, and quality of life measures. For audiological research, U.S. military personnel offer a unique research population, as they are exposed to noise levels and blast environments that are highly unusual in civilian work settings and can serve as a model population for studying the impact on QOL associated with these conditions. Our team recommends conducting a study on the active-duty service member population using a measurement instrument suitable for determining decreases in QOL specifically due to hearing loss.
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http://dx.doi.org/10.1186/s40779-016-0082-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4830069PMC
April 2016

Economic Burden of Hearing Loss for the U.S. Military: A Proposed Framework for Estimation.

Mil Med 2016 Apr;181(4):301-6

Department of Defense Hearing Center of Excellence, 59MDW/SG02O, 2200 Bergquist Drive, Suite 1, JBSA Lackland, TX 78236.

The goal of this multiphased research is to develop methods to comprehensively determine the economic impact of hearing impairment and noise-induced hearing injury among active duty U.S. Service Members. Several steps were undertaken to develop a framework and model for economic burden analysis: (1) a literature review identifying studies reporting the cost of health conditions and injuries in the Department of Defense, (2) consultation with a panel of subject matter experts who reviewed these cost items, and (3) discussions with DoD data stewards and review of relevant data dictionaries and databases. A Markov model was developed to represent the cumulative economic effect of events along the career span, such as retraining after hearing impairment and injury, by synthesizing inputs from various sources. The model, as developed and proposed in this study, will be a valuable decision-making tool for the DoD to identify high-risk groups, take proactive measures, and develop focused education, customized equipping, and return-to-duty and reintegration programs, thereby maximizing the retention of skilled, experienced, and mission-ready Service Members.
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http://dx.doi.org/10.7205/MILMED-D-14-00612DOI Listing
April 2016

Office-Based Cataract Surgery: Population Health Outcomes Study of More than 21 000 Cases in the United States.

Ophthalmology 2016 Apr 22;123(4):723-8. Epub 2016 Jan 22.

Oregon Health & Science University, Portland, Oregon.

Purpose: To identify safety and effectiveness outcomes of office-based cataract surgery. Each year, approximately 3.7 million cataract surgeries in the United States are performed in Ambulatory Surgery Center (ASC) and Hospital Outpatient Department (HOPD) locations. Medicare in July 2015 published a solicitation for expert opinion on reimbursing office-based cataract surgery.

Design: Large-scale, retrospective, consecutive case series of cataract surgeries performed in Minor Procedure Rooms (MPRs) of a large US integrated healthcare center.

Participants: More than 13 500 patients undergoing elective office-based cataract surgery.

Methods: Phacoemulsification cataract surgery performed in MPRs of Kaiser Permanente Colorado from 2011 to 2014.

Main Outcome Measures: Postoperative visual acuity and intraoperative and postoperative adverse events (AEs).

Results: Office-based cataract surgery was completed in 21 501 eyes (13 507 patients, age 72.6±9.6 years). Phacoemulsification was performed in 99.9% of cases, and manual extracapsular extraction was performed in 0.1% of cases. Systemic comorbidities included hypertension (53.5%), diabetes (22.3%), and chronic obstructive pulmonary disease (9.4%). Postoperative mean best-corrected visual acuity measured 0.14±0.26 logarithm of the minimum angle of resolution units. Intraoperative ocular AEs included 119 (0.55%) cases of capsular tear and 73 (0.34%) cases of vitreous loss. Postoperative AEs included iritis (n = 330, 1.53%), corneal edema (n = 110, 0.53%), and retinal tear or detachment (n = 30, 0.14%). No endophthalmitis was reported. Second surgeries were performed in 0.70% of treated eyes within 6 months. There were no life- or vision-threatening intraoperative or perioperative AEs.

Conclusions: This is the largest US study to investigate the safety and effectiveness of office-based cataract surgery performed in MPRs. Office-based efficacy outcomes were consistently excellent, with a safety profile expected of minimally invasive cataract procedures performed in ASCs and HOPDs.
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http://dx.doi.org/10.1016/j.ophtha.2015.12.020DOI Listing
April 2016

Are Dental Implants the Answer to Tooth Loss in Patients with Parkinson's Disease?

Authors:
Mark E Packer

Prim Dent J 2015 May;4(2):35-41

King's College London Dental Institute, London, UK.

Individuals with Parkinson's disease present a challenge to dental clinicians as this degenerative disease leads to problems accessing care and maintaining an adequate level of oral health. This article provides an overview of the implications of Parkinson's disease on oral health and explores the role of dental implants in the management of such patients.
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http://dx.doi.org/10.1308/205016815814955091DOI Listing
May 2015

Anaplastic large-cell lymphoma presenting as a nasopharyngeal mass and cervical lymphadenopathy.

Ear Nose Throat J 2015 Jun;94(6):E26-9

Otolaryngology-Head and Neck Surgery Service, San Antonio Military Medical Center, ATTN: MCHE-SDT (Oto), 3551 Roger Brooke Dr., Ft. Sam Houston, TX 78234, USA.

Cervical lymphadenopathy in adults has a broad differential diagnosis, including bacterial and viral infections, Kikuchi-Fujimoto disease, systemic lupus erythematosus, and various neoplasms. Many of its etiologies share similar symptomatology and presentations, which complicates the diagnosis. A thorough history and a comprehensive physical examination, to include nasopharyngoscopy and imaging as indicated by the specific case, are key to determining the origin of the lymphadenopathy and to avoid a missed or delayed diagnosis. Based on our review of the literature, we present the second reported case of anaplastic lymphoma kinase-positive anaplastic large-cell lymphoma presenting in an adult with an obstructing adenoid/nasopharyngeal mass and lymphadenopathy. The mass, which occurred in a 19-year-old woman of Asian descent, caused nasal airway obstruction in the setting of cervical lymphadenopathy that was initially ascribed to mononucleosis.
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http://dx.doi.org/10.1177/014556131509400617DOI Listing
June 2015

Defining the ideal femtosecond laser capsulotomy.

Br J Ophthalmol 2015 Aug 31;99(8):1137-42. Epub 2015 Mar 31.

Lensar, Orlando, Florida, USA.

Purpose: We define the ideal anterior capsulotomy through consideration of capsular histology and biomechanics. Desirable qualities include preventing posterior capsular opacification (PCO), maintaining effective lens position (ELP) and optimising capsular strength.

Methods: Laboratory study of capsular biomechanics and literature review of histology and published clinical results.

Results: Parameters of ideal capsulotomy construction include complete overlap of the intraocular lens to prevent PCO, centration on the clinical approximation of the optical axis of the lens to ensure concentricity with the capsule equator, and maximal capsular thickness at the capsulotomy edge to maintain integrity.

Conclusions: Constructing the capsulotomy centred on the clinical approximation of the optical axis of the lens with diameter 5.25 mm optimises prevention of PCO, consistency of ELP and capsular strength.
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http://dx.doi.org/10.1136/bjophthalmol-2014-306065DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4518749PMC
August 2015

The Department of Defense Epidemiologic and Economic Burden of Hearing Loss study.

Mil Med 2014 Dec;179(12):1458-64

Department of Defense Hearing Center of Excellence, 59MDW/SG02O, 2200 Bergquist Drive, Suite 1, JBSA Lackland, TX 78236.

Although studies have examined the relation between military-related noise and hearing, comprehensive data to calculate rates of hearing loss across all Services and to determine economic impact are lacking. The goal of the multiphase Department of Defense (DoD) Epidemiologic and Economic Burden of Hearing Loss (DEEBoHL) project is to examine rates of hearing impairment and noise-induced hearing injury, relevant noise exposures, and to determine the economic burden of these outcomes to the DoD and Service Members. The DoD Hearing Center of Excellence is supporting the following Phase I specific aims, among active duty Service Members to (1) calculate rates of hearing impairment and noise-induced hearing injury, and (2) develop a framework for the DoD to conduct comprehensive economic burden studies for hearing impairment and noise-induced hearing injury. The study is led by a multidisciplinary team from The University of Texas School of Public Health, The University of Texas Health Science Center at San Antonio, and The Geneva Foundation, with guidance from experts who make up the study advisory board. In this article, we focus on an overview of the DEEBoHL study, the methods for the first aim of this effort, and describe future plans for the study.
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http://dx.doi.org/10.7205/MILMED-D-14-00100DOI Listing
December 2014

Continuation of anticoagulant and antiplatelet therapy during phacoemulsification cataract surgery.

Curr Opin Ophthalmol 2015 Jan;26(1):28-33

aDepartment of Ophthalmology, Poznan City Hospital, Poznań bDepartment of Ophthalmology, University of Warmia and Mazury, Olsztyn, Poland cDepartment of Ophthalmology, 'Lozano Blesa' University Clinic Hospital dAragon Health Sciences Institute, Zaragoza, Spain eDepartment of Ophthalmology, Oregon Health & Science University, Portland, Oregon, USA.

Purpose Of Review: The objective of this review is to evaluate the result of cataract surgery in patients continuing antiplatelet and/or anticoagulant treatment.

Recent Findings: The number of elderly patients using anticoagulant and antiplatelet treatment in prevention of venous thromboembolism has significantly increased in recent years. It was believed for many years that those patients might be at higher risk for complications during ocular surgery. Thus, different strategies were proposed to prevent these complications, including discontinuation of anticoagulants, dose reduction, or low-molecular-weight heparin replacement. We performed a PubMed search over a period of 7 years (2007-2013) about possible intraoperative and postoperative complications in patients receiving anticoagulant and/or antiplatelet therapy at the time of cataract surgery. No significant increase in intraoperative or postoperative complications has been identified.

Summary: Phacoemulsification of uncomplicated cataracts with intraocular lens implantation can be performed safely in high-risk patients, taking both anticoagulants and antiplatelet drugs when topical anesthesia is administered and cataract surgery is performed through a clear corneal incision by a skilled surgeon.
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http://dx.doi.org/10.1097/ICU.0000000000000117DOI Listing
January 2015
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