Compared to glasses, contact lens wear offers improved vision-related quality of life benefits for children and teenagers according to a recent study funded by Vistakon, division of Johnson & Johnson Vision Care, Inc. At the American Academy of Optometry meeting, the study investigators reported that findings from the multi-site, three-year study suggest that children who require vision correction should be given the option of being fitted with contact lenses. A total of 484 eight-to 11-year-old myopic children participated in the randomized, single-masked trial conducted from September 2003 to October 2007 at five clinical centers in the United States. Children were randomly assigned to wear spectacles (n= 237) or contact lenses (n = 247) for three years. Using the Pediatric Refractive Error Profile (PREP), an instrument used to compare the vision-specific quality of life between children affected only with refractive error, researchers compared the two groups. The PREP survey was administered at baseline, one month, and every six months from baseline for three years. Children who wore contacts saw greater improvement in satisfaction with their choice of vision correction, appearance, and participation in activities, with differences detected as early as one month.
     "Studies have shown glasses to be associated with negative attributes in areas of self-perception and attractiveness, so it's not surprising that children experience quality-of-life benefits beyond vision correction from contact lens wear," said Marjorie Rah, OD, PhD, FAAO, New England College of Optometry, and lead author of this report from the Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study. "The growing body of research in this area demonstrates that contact lenses significantly improve how children feel about their physical appearance and participating in activities such as sports," she added. "This should give doctors and parents greater confidence in presenting children with the option of contact lens wear when vision correction is required, especially those children active in sports or those who don't like how they look in glasses."

With Halloween approaching, the American Optometric Association (AOA) is warning consumers about the risks of wearing decorative contact lenses without a prescription from an eye doctor. Non-corrective lenses, which are designed only to change the appearance of the eyes, are easily accessible to consumers and are especially popular around Halloween.
     Although federal law requires the Food and Drug Administration (FDA) to regulate decorative lenses as a medical device, decorative lenses continue to be illegally marketed and distributed directly to consumers through a variety of sources including flea markets, the Internet, beauty salons and convenience stores. This warning comes at a time of heightened consumer interest in changing one's eye color. New results from the AOA's American Eye-Q survey indicate that more than half of all Americans would consider changing the color of their eyes with colored lenses.
     Consumers are advised to visit http://www.aoa.org for more information about the risks of decorative contact lenses, or to find additional resources pertaining to contact lens hygiene and compliance. 

Polyquad and Aldox, the dual disinfectants in both Opti-Free Replenish and Opti-Free Express Multi-Purpose Disinfecting Solutions (MPDS), were first introduced as the disinfecting system in the Opti-Free franchise in 1998. Since launch, approximately 147 million soft contact lens wearers have used either Opti-Free Replenish or Opti-Free Express to care for their lenses, according to information from Alcon.
     Per the company, Polyquad and Aldox is the only dual disinfecting system available in an MPS. The performance of Polyquad/Aldox dual disinfectants is attributed to synergy between the disinfecting agents polyquaternium-1 (Polyquad) and myristamidopropyl dimethylamine (Aldox). Polyquad, like many single entity PHMB products, provides generally good coverage against bacteria, fungi, yeasts and molds. Aldox was added to increase coverage against fungi and provide additional activity against Acanthamoeba cysts and trophs. According to Alcon, this unique combination allows the MPDS products Opti-Free Replenish and Opti-Free Express to offer a broad disinfecting profile.
     "Dual disinfection optimizes disinfection efficacy while minimizing corneal staining," explains David Meadows, Alcon's Vice President, R&D, Consumer Products. Dr. Meadows goes on to explain, "This balance between disinfection efficacy and biocompatibility is problematic for some traditional single entity disinfection systems. As lens material designs become more complicated, dual disinfection systems, like Polyquad/Aldox, offer an effective strategy to maximize overall performance in multi-purpose solution products."

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The EyeVis Eye and Vision Research Institute announced the completion of one year data for the SMART Study (Stabilization of Myopia by Accelerated Reshaping Technique). The SMART study recruited over 250 test (contact lens corneal reshaping) and control (soft silicone hydrogel daily wear) subjects, ages 8 to 14, at initiation of the planned five year longitudinal, multicenter evaluation of the ability of corneal reshaping contact lenses to control myopic progression. "Initial analysis of the one year data is very encouraging in regard to the ability of corneal reshaping lenses to control myopic progression vs. the use of daily wear soft contact lenses in the study sample," said S. Barry Eiden, OD, FAAO and Robert Davis, OD, FAAO, the principal investigators of the SMART study. Detailed reporting of one year data will be presented at the upcoming Global Specialty Contact Lens Symposium in Las Vegas in January, 2009.

Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced preliminary results from a pivotal anterior uveitis trial that compared Durezol (difluprednate ophthalmic emulsion) 0.05% dosed four times daily (QID) to Pred Forte (prednisolone acetate ophthalmic suspension) 1%, dosed eight times daily. Durezol is a topical ophthalmic corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery; it was approved by the U.S. Food and Drug Administration in June, 2008.
     Ninety patients with endogenous anterior uveitis were studied in a multicenter, randomized, double-masked trial. Treatment for both study groups was administered for 14 days, with two weeks of tapering at half the dose and two weeks of follow-up (for a total 42 days) after initiation of therapy. The primary endpoint was the difference from baseline in anterior chamber (AC) cell grades between the Durezol and Pred Forte groups. At Day 14, the Durezol group achieved a mean cell grade reduction of 2.1, compared to 1.9 in the Pred Forte group, confirming the noninferiority of Durezol dosed QID to Pred Forte dosed eight times a day.

The College of Optometrists in Vision Development (COVD) reported on a recently released study from the National Institute of Health showing that there is a more effective treatment for children who have a common reading-related vision disorder. According to the COVD, convergence insufficiency (CI), a common childhood eye muscle coordination problem, is often missed in many routine vision screenings because these screenings test distance vision, not the visual skills required for reading. For this reason many children can be misdiagnosed with learning disabilities when, in fact, they have a treatable eye condition, per the COVD.
    The NIH study was a collaborative study with both optometrists and ophthalmologists involved in nine sites throughout the United States. The study included 221 children ages 9 to 17 and compared different forms of treatment, including the most commonly prescribed "pencil push-ups" in addition to a placebo therapy activity. After 12 weeks of treatment, nearly 75 percent of the children that were given office-based Vision Therapy along with at-home reinforcement exercises achieved normal vision or had significantly fewer symptoms of CI. While there have been hundreds of studies over the years, this is the first scientific study to look at these treatment protocols.
    "This study shows that, once diagnosed, CI can be successfully treated with office-based vision therapy by a trained therapist along with at-home reinforcement. This is very encouraging news for parents, educators, and anyone who may know a child with CI," said principle investigator Mitchell Scheiman, OD, of Pennsylvania College of Optometry at Salus University.
    Pamela Happ, Executive Director of the COVD stated, "Many eye care professionals, as well as parents, doubted which treatment options for convergence insufficiency were effective. Now this definitive, double-blind, masked, placebo-controlled study demonstrates conclusively that in-office vision therapy by trained professionals is the most effective solution." 

Join Contact Lens Spectrum and the Health Care Conference Group for the Global Specialty Lens Symposium (GSLS), January 15-18, 2009, at Bally's Hotel and Casino in Las Vegas, NV. The GSLS will include presentations on the latest techniques and technologies for the successful management of ocular conditions - from presbyopia to pediatric vision correction - using today's specialty contact lenses. Truly an international meeting, GSLS will provide insights of experts from around the globe and hands-on access to the most current products available. The program will be accredited for continuing education under COPE, NCLE and JCAHPO, offering 17+ credit hours. 
     Visit www.GSLSymposium.com for more information or to register for this unique meeting. Companies interested in exhibiting should contact Sean Casey at 732-483-4302 or sean.casey@wolterskluwer.com.
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The tisilfocon A (Menicon Z) rigid gas permeable (GP) contact lens polymer has the highest oxygen permeability (Dk) value of any GP lens material. To the authors' knowledge there is no published literature documenting the success of this material in fitting contact lenses to highly irregular and diseased corneas. A retrospective medical record review of 40 consecutive patients (64 eyes) who had worn lenses made in the Menicon Z GP material was performed. All patients had some form of corneal pathology and were fitted in a single tertiary care hospital-based contact lens service.
     Menicon Z contact lenses were fit to 33 eyes of 20 patients with keratoconus (KC) and 31 eyes of 23 patients with irregular corneas. The irregular cornea group comprised 28 eyes of 21 patients after corneal surgery, one eye with ocular cicatricial pemphigoid and two eyes of one patient with chronic staphylococcal blepharo-keratoconjuncitivitis. Treatment goals included acceptable corneal physiology, comfort, and visual acuity. In the KC group, there was an 82% (27/33 eyes) success rate as measured by the treatment goals. Mean duration of wear for successful patients was 2.5 years (0.5-5 years). Only 12% (4/33 eyes) failed directly due to inability of the Menicon Z material to perform adequately while another material was acceptable. In the irregular surface group (surgical and ocular surface disease), there was a 74% (23/31 eyes) success rate. Mean duration of wear for successful patients in this group is 2.79 years (3 months-7 years). Only 3% (1/31 eyes) failed directly due to inability of the Menicon Z material to perform adequately while another material was acceptable.
     The authors concluded that the tisilfocon A hyper Dk lens material maintains clinically acceptable corneal health and clinically acceptable visual acuity for patients with KC and irregular corneal surfaces. In this series of patients with complicated corneal disease, the most failures were due to design issues and discomfort not related to the Menicon Z material. The Menicon Z material was inadequate in only 8% of eyes, whereas another GP material was successful. Most patients with irregular corneas in a tertiary care center can be successfully fit with the tisilfocon A GP material for visual rehabilitation.
Szczotka-Flynn LB, Patel S. Menicon Z rigid gas permeable lenses for keratoconus and irregular corneas: a retrospective case series. Eye Contact Lens 2008;34:254-60.

We continue to receive reader thoughts on corneal staining. Here are a couple of representative comments.

Although it is well established that some combinations of lenses and solutions can cause corneal staining and that research centers also associate asymptomatic infiltrates with the presence of staining, this back and forth has ceased to "move the ball forward." I don't think that much research that has been presented lately helps the clinician understand what to make of any of these clinical signs. It is akin to the sometimes ridiculous tone that political campaigns can take; taking normal information to extremes for commercial interest in this case. 
     My fear is that some of these scare tactics may discourage the recommendation of contact lenses in favor of refractive surgery that we know has significant downside risk compared to contact lens wear, even on a continuous wear basis. Those patients are more likely to develop intractable dry eye, glare that can't be managed by optical means and occasionally refractive conditions that require further use of contact lenses. 
     The patient is not being served very well with the state of the discussion now. 
Robin L Chalmers, OD
Clinical Trial Consultant
Atlanta, GA
 
Your questions on contact lens related corneal staining have been the subject of much debate in our industry as you know. One side says that although asymptomatic, it is significant and others believe that it goes with the territory, so to speak, and really has no significance at all since the staining is at such low levels. Having been directly involved in two of these staining studies and seeing the effect of different contact lens solutions on the type, area and depth of corneal staining, I believe that there is some significance to this issue and that we should not take a cavalier approach to this subject when dealing with our patients even when they are asymptomatic. 
     My feeling is that although this may not be an acute problem, it may, in fact, pose a problem long term and as contact lens fitters, we need to be cognizant of possible future issues as well as ones that present immediately. We cannot say with complete certainty that some staining will not be an issue for long term comfort for our patients and therefore, I believe it is incumbent on us as practitioners to change whatever the offending regimens might be to something else that has a better track record given the specific lens type and its interaction with the solutions used. It may be overkill when nothing else seems to be wrong but as the saying goes, "an ounce of prevention is worth a pound of cure."
John L. Schachet, OD
Englewood, CO

Keratoconus is a condition with which many of our patients struggle. It has the potential to have a big impact on their quality of life. Many clinicians believe that the traditional estimates of its frequency in the population actually underestimate the true prevalence of the disease. Keratoconus is also traditionally described as a non-inflammatory ectasia, but some question this as well, particularly as it relates to inflammation and the condition. Studies are focusing on the genetic and cellular changes occurring in the disease, which may shed more light on its cause. It has been wonderful to see many new contact lens materials and designs emerge into clinical practice over the last few years, and I am sure they have benefited your patients.
Jason J. Nichols, OD, MPH, PhD, FAAO

This month at www.siliconehydrogels.org: multipurpose solutions, one- and two-step peroxide solutions and the effect of continuous wear on epithelial barrier function.