I recently read a very interesting article in the Wall Street Journal about the U.S. FDA, which shared some perspectives as to how we might consider evolving drug and medical device approvals (http://blogs.wsj.com/experts/2016/06/29/its-time-to-radically-change-how-the-fda-approves-drugs/?mod=e2tw). The article in essence argued that the FDA should continue to scrutinize drugs and devices via its thorough review process (e.g., safety and efficacy for drugs and equivalence for medical devices), but that the current “approve/not approve” system is archaic leaving very little options for practitioners and patients that may benefit from unapproved drugs and devices otherwise. The author argued rather that the FDA should act more like Consumer Reports, with ratings for safety and efficacy and degree of evidence for each compound or device. This would leave practitioners (and patients) with more options and starting points in terms of their care, of course, shifting more responsibility and risk to them in making these decisions.
Jason J. Nichols, OD, MPH, PhD
J&J Introduces Monthly Lens, Acuvue Vita
Johnson & Johnson Vision Care, Inc. announced the U.S. launch of Acuvue Vita Brand, a 30-day daily wear contact lens with new HydraMax Technology.
Acuvue Vita with HydraMax Technology is a new non-coated silicone hydrogel formulation. According to the company, this Eye-Inspired Design helps:
Maximize and maintain lens hydration all month long
Enhance comfort through a unique Infinity Edge
Provide UV protection by blocking approximately 93.4% of UVA rays and 99.8% of UVB rays
The HydraMax Technology in Acuvue Vita helps maximize lens hydration by integrating the maximum amount of hydrating agent in this lens and then, maintains hydration through optimal density and distribution of beneficial lipids throughout this lens, per the company announcement. In addition the material in Acuvue Vita, senofilcon C, is designed to integrate the optimal density and distribution of beneficial lipids throughout this lens, while maintaining a low deposition profile. A natural function of lipids in the tears is to help protect against tear film evaporation. Acuvue Vita leverages the function of these beneficial lipids to help maintain lens hydration with a reduced evaporation rate through this lens. The company states that the evaporation rate of Acuvue Vita is 33% lower than other leading monthly brands.
CooperVision, Inc. announced the introduction of Biofinity Energys with Digital Zone Optics lens design, contact lenses specifically created for digital device users. The lenses will be rolled out on a phased basis in the U.S. beginning in July, and will enter select European markets later this year.
According to the company, two elements are at the heart of the lens’ performance and unique optimization for digital device users:
Digital Zone Optics lens design, the breakthrough that integrates multiple front-surface aspheric curves across the entire optical zone. These curves distribute power evenly, simulating more positive power in the center of the lens. This helps ease accommodative burden as wearers move their gaze from on-screen to off-screen and back with less effort.
Aquaform Technology, which attracts and binds water throughout the silicone hydrogel lens material (comfilcon A) to retain moisture and help alleviate dryness even during times of reduced blinking, which is common with digital device use. Long silicone chains optimize oxygen transmissibility, and reduced silicone content results in a low modulus for softness and flexibility, enhancing comfort and fitting versatility.
The lenses also incorporate a smooth, naturally wettable surface design with a special rounded edge. This reduces conjunctival interaction, improving wearing comfort.
Biofinity Energys lenses will be available in the same material (comfilcon A, 48 percent water content) and parameter range as Biofinity sphere lenses, with an 8.6 mm base curve, 0.08 mm center thickness at -3.00D, and 14.0 mm diameter in sphere powers from +8.00 to -12.00. The Dk/t of Biofinity Energys is also the same as Biofinity sphere (160 at -3.00D).
To address the eye health challenges posed by increasing screen time, CooperVision has launched FightEyeFatigue.com – a resource that can help eye care professionals begin conversations with patients about device use in a humorous, realistic and non-threatening manner.
The Educational Program Committee of the Global Specialty Lens Symposium invites the submission of abstracts for the Free Paper Section and the Scientific Poster Competition. Papers and posters related to presbyopia, keratoconus, corneal topography, post penetrating keratoplasty or related irregular corneal surface, myopia control, orthokeratology and lens care topics are welcome.
The GSLS will be held January 19-22, 2017 at The Rio Hotel in Las Vegas, Nevada. Visit www.GSLSymposium.com for more information. Web submissions only. Deadline for submissions is August 31, 2016.
The Association of Schools and Colleges of Optometry (ASCO) recognized its annual awards recipients during ASCO’s annual luncheon in Boston during the AOA. Honorees included:
MA Lifetime Achievement Recipient – Dr. Morris Berman
Dr. Berman, of the Southern California College of Optometry at Marshall B. Ketchum University (SCCOMBKU), has exemplified what it means to be a leader in optometric education, having made and continuing to make outstanding contributions. Dr. Berman has displayed extraordinary commitment and dedication to SCCOMNKU, ASCO, optometric education, the profession, and to the public, both in the U.S. and abroad.
Industry Leadership Award Recipient – R. Mike Daley
Mr. Daley, The Vision Council’s Chief Executive Officer, is recognized for his long history of support of ASCO and his enthusiasm, professionalism and leadership. He has consistently championed programs that have advanced and enhanced optometric education and have benefited students, faculty and residents.
Rising Star Award Recipient – Dr. Nathan Lighthizer
Northeastern State University, Oklahoma College of Optometry’s (NSUOCO) Director of Continuing Education, Dr. Nathan Lighthizer, is recognized for his outstanding contributions to NSUOCO through teaching, scholarship, administration and professional service and most noticeably in contributions to ASCO’s Clinical Directors/Administrators Special Interest Group.
Rising Star Award Recipient – Dr. Nicole Ross
Dr. Nicole Ross, Assistant Professor of Optometry at the New England College of Optometry (NECO), is recognized for her outstanding contributions to NECO through teaching, scholarship, administration and professional service and most noticeably in contributions to ASCO’s Low Vision Special Interest Group.
Allergan Donates Refresh Eye Drops to America's First Responders
Allergan plc announced that it has exceeded its goal of donating $1 million worth of Refresh eye drops to our nation's first responders. Last summer, Allergan kicked off the Refresh America campaign aiming to help everyday heroes alleviate their discomfort from dry eye symptoms brought on by exposure to elements like heat, wind, smoke and dust which are inherent to their work. Every purchase of specially-marked packages in the Refresh Optive product line since August 2015 has led to over eighty thousand donations of Refresh eye drops to first responder groups nationwide.
Allergan partnered with the U.S. First Responders Association for this initiative, who helped designate where Refresh eye drop donations were most needed.
While Allergan's goal was to reach $1 million in Refresh products, there is no limit to the amount the company will donate during this campaign. Due to the positive receptivity of first responders and the communities in which they serve, Allergan has recently announced that it will extend the Refresh America program through the end of 2017. Learn more at helpRefreshAmerica.com.
Visionary Optics announced the addition of Cris Garza as a Clinical and Field Consultant. His background includes work as a consultant, a contact lens fitter specializing in therapeutic and specialty fitting, and work as a clinical educator. Garza has also worked as a clinical research assistant, and an ophthalmic technician. A member of the Contact Lens Society of America and the Scleral Lens Society, Garza is an NCLE Advanced Certified Contact Lens Technician, an ABO Certified Optician, and a Certified Ophthalmic Technician.
Johnson & Johnson Vision Care, Inc. announced its commitment of support to the Think About Your Eyes public awareness campaign, led by The Vision Council and American Optometric Association (AOA). The company has committed $1.8 million in support of the program which is designed to educate the public about eye health and promote the importance of getting an annual comprehensive eye exam.
According to the Centers for Disease Control and Prevention, in the United States, approximately 14 million individuals aged 12 years and older have visual impairment, among which more than 80% could be corrected to good vision with refractive correction. And, an estimated 61 million adults in the United States are at high risk for serious vision loss, but only half visited an eye doctor in the past 12 months.
Think About Your Eyes brings national awareness to the importance of eye health by providing resources on a variety of topics including eye diseases, impact of eye strain, children’s eye development, and how to determine which form of vision correction is best for you. The program encourages people to visit the campaign’s website, www.ThinkAboutYourEyes.com, where they can access a tool to easily locate eye care providers near them.
OCULAR SURFACE UPDATE Katherine M. Mastrota, MS, OD, FAAO
Sleep Disturbance and DED
A 2016 study from Japan concluded that sleep quality is associated with DED: sleep disturbance seems to be an influencing factor on DED, especially on dry eye symptoms. This suggestion does not surprise me in the least.1 We already are familiar with OSD in patients with sleep fractured by sleep apnea, often associated with Floppy Eyelid Syndrome. Note that our Japanese study was a cross-sectional survey conducted mainly among young and middle-aged Japanese office workers, who used visual display technology. No mention of body type was offered, limiting our knowledge of FES patients in the study if any.
What was more interesting to me was how sleep disturbance was identified and quantified. Our referenced study authors used the Pittsburg Sleep Quality Index questionnaire.
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.2 The PSQI measures the quality and patterns of sleep in the older adult by measuring seven domains. It consists of 19 individual items generating seven “component” scores: subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. This validated questionnaire differentiates “poor” from “good” sleep.
This begs the question: should we incorporate a validated sleep survey into our dry eye exams?
There are numerous validated global and targeted (e.g., pediatric patients, obstructive sleep apnea) patient sleep/sleepiness/insomnia questionnaires available. Patient survey results may add the extra clinical sign/symptom that may be the “tipping point” for our OSD patients the management of which should be addressed.
1. Kawashima M, Uchino M, Yokoi N, Uchino Y, Dogru M, Komuro A, Sonomura Y, Kato H, Kinoshita S, Tsubota K. The association of sleep quality with dry eye disease: the Osaka study. Clin Ophthalmol. 2016 Jun 1;10:1015-21.
2. Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: A new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28 (2): 193–213
The role of eye rubbing in keratoconus has been discussed over many decades. It seems to be fairly universally agreed upon that vigorous eye rubbing should be avoided by individuals with both naturally occurring and iatrogenic forms of corneal ectasia to avoid further induced progression of the disease.
A recent article1 was published by who most would consider the world’s expert on the topic of eye rubbing, Dr. Charles McMonnies. This study examined the prevalence of 'removal-relief' rubbing and its potential consequences. Rubbing histories were recorded for contact lens wearing normal and keratoconic patients as well as for normal non-contact lens wearers. Analogue scaled responses were used to identify and compare abnormal rubbing habits. The outcomes of the study found that contact lens wearing patients (both with and without keratoconus) reported significantly more rubbing before contact lens insertion (p < 0.05) compared to non-contact lens wearers. Eye rubbing after contact lens removal ('removal-relief' rubbing) was found to be significantly more frequent among contact lens-wearing keratoconic patients compared to contact lens-wearing non-keratoconic patients (p < 0.001 in both cases). Dr. McMonnies concluded that eye rubbing-related trauma occurring before contact lens insertion may predispose the cornea to wound healing activities and greater levels of adverse response to contact lens wear. Such adverse responses could predispose the cornea to greater trauma, which occurs in response to rubbing on removal of contact lenses. Strong counselling to avoid eye rubbing is often not an adequate form of management for a significant number of patients with keratoconus. Evidence of relapses indicates the need for better methods of counselling and for them to be repeated regularly. Apart from keratoconus, any other keratectasia, corneal disease or wound healing (including post-surgical) may increase susceptibility to corneal rubbing trauma. Such cases also appear to warrant counselling on avoidance of rubbing.
Although it is clearly evident that naturally occurring keratoconus has strong hereditary components that result in abnormal collagen and abnormal biomechanical properties, environmental influences on disease progression, such as vigorous eye rubbing, can be quite deleterious. This article and others2,3 published by Dr. McMonnies have served to further our knowledge and understanding of the role eye rubbing plays in cornea diseases such as keratoconus.
1. McMonnies CW. Eye rubbing type and prevalence including contact lens 'removal-relief' rubbing. Clin Exp Optom. 2016 Jun 16. (Epub ahead of print).
2. McMonnies CW. Abnormal rubbing and keratectasia. Eye Contact Lens. 2007 Nov;33(6 Pt 1):265-71.
3. McMonnies CW. Mechanisms of rubbing-related corneal trauma in keratoconus. Cornea. 2009 Jul;28(6):607-15.
Care System Versus Transmitted Light Wavefront Pattern of Contact Lenses
This article compares the optical performance of soft contact lenses (CLs) treated with multipurpose or hydrogen peroxide care systems.
The investigated care systems were (1) 3% hydrogen peroxide solution Oxysept (Abbott Medical Optics, Abbott Park, IL) and (2) multipurpose solution Regard (Vita Research, Ariccia, Italy). Three types of silicone hydrogel CLs were studied (comfilcon A, lotrafilcon B, and balafilcon A), unworn and exposed for 30 times to the solutions, which were replaced every 8 hours. The optical performance of the CLs was evaluated through the on-eye transmitted light wavefront patterns by considering new CLs as references. The surface morphology of the CLs was investigated by scanning electron microscopy.
Statistically significant modifications in the range 0.1 to 0.3 μm of Zernike coefficients and modifications of the root mean square of the wavefront aberration function were found for CLs treated with multipurpose solution, in agreement with the observed modifications of the surface morphology. Statistically significant changes were also found after exposure to the hydrogen peroxide solution, but the variation of the Zernike coefficients was found lower than 0.1 μm, thus being negligible in CL optical performances.
The authors concluded that, in addition to disinfection ability and ocular surface reactions, CL care systems are different in solution-related CL optical performance. Multipurpose solutions may affect the CL surface morphology with significant modifications of the transmitted light wavefront pattern.
Chiericati S, Borghesi A, Cozza F, Ferraro L, Acciarri M, Farris S, Tavazzi S. Care System Versus Transmitted Light Wavefront Pattern of Contact Lenses. Eye Contact Lens. 2016 Apr 13. [Epub ahead of print]