Thomas L. Steinemann

Ocular complications associated with the use of cosmetic contact lenses from unlicensed vendors.

Purpose To call attention to the unauthorized sale of cosmetic contact lenses, resulting in ocular complications. Design Observational case report. Methods Retrospective, observational, clinical practice setting. Results Six patients (five female and one male) were seen urgently for acute eye pain and redness after wearing cosmetic plano contact lenses. None of the patients had previously worn a contact lens or spectacle correction. None of the lenses were dispensed by eye care professionals. One patient developed pseudomonal keratitis, ultimately requiring penetrating keratoplasty for visual rehabilitation. Conclusions Colored contact lenses are being dispensed without a prescription or fitting from unlicensed vendors, such as cosmetics, convenience, and accessory stores. Lenses are sold individually and without care instructions. Consequently, uninformed lens wearers are experiencing acute, vision-threatening infections and inflammation.

Over-the-counter decorative contact lenses: Cosmetic or Medical Devices? A Case Series.

Purpose. To illustrate the implications of the unauthorized sale and unmonitored wearing of decorative cosmetic contact lenses resulting in ocular complications and to determine the prevalence of the use of cosmetic contact lenses obtained from unlicensed providers by adolescents. Methods. Observational case report, structured interview, and survey in a retrospective, observational, clinical practice setting. Reported sources of contact lenses were categorized as provider and nonprovider, and associations within the data were reviewed by using a Pearson correlation and chi-square test. Results. Twelve patients (eight female and four male) were seen urgently for acute eye pain and redness after wearing plano decorative contact lenses. None of the patients had previously worn a contact lens. None of the lenses were dispensed by eye care professionals. Four patients developed blinding infections requiring hospital admission. Causative organisms included staphylococci, Pseudomonas, and acanthamoeba. One patient required a penetrating keratoplasty. One hundred fifty-nine patients were surveyed. Thirty-seven (23%) used decorative contact lenses. Lenses were obtained from an unlicensed provider 51% of the time. Education about lens care and handling was significantly associated with acquiring lenses from licensed providers (R = 0.74, P<0.0001). Conclusions. Colored noncorrective contact lenses are being dispensed without a prescription or fitting from unlicensed vendors. Patients who acquire lenses from unauthorized providers are significantly less likely to be instructed on appropriate lens use and care. Consequently, uninformed lens wearers are experiencing acute vision-threatening infections and inflammation.

Chronic exposure keratopathy complicating surgical correction of ptosis in patients with chronic progressive external ophthalmoplegia

PURPOSE To report chronic exposure keratopathy related to surgical ptosis correction in patients with chronic, progressive, external ophthalmoplegia. METHODS Case reports of three patients with chronic exposure keratopathy following blepharoptosis surgery. RESULTS We report three patients with chronic progressive external ophthalmoplegia with chronic corneal complications after surgical ptosis repair. All three gave a history of blepharoptosis and extraocular muscle dysfunction. Each presented with chronic corneal ulceration. All had histories suggestive of ophthalmoplegia. Treatment of corneal ulceration necessitated hospitalization and surgical intervention. CONCLUSION Patients with chronic, progressive, external ophthalmoplegia have little ability to properly protect the eye from exposure and are at risk for corneal damage. A thorough ophthalmic history and examination before ptosis surgery may prevent the corneal complications resulting from surgical intervention.

Special commentary: Food and Drug Administration, American Academy of Ophthalmology, American Academy of Optometry, American Optometric Association and the Contact Lens Association of Ophthalmologists Cosponsored Workshop: Revamping microbiological test methods for contact lenses, products, and accessories to protect health and ensure safety

Contact lenses are widely used medical devices, with approximately 39.2 million wearers in the United States as of 2014. Proper care of these medical devices is a multifaceted process that involves cleaning and disinfection, proper maintenance of cases for lens storage, and diligence of the user with respect to wearing and replacement schedules. Although patient adherence to these aspects of lens care is critical to prevent infection and other complications, nonadherence characterized by improper cleaning, care, and replacement of lenses is common. Reuse or “topping off” of care product solutions, hygiene behaviors, and use and/or storage of lenses in tap water were cited as contributing factors to the Fusarium keratitis outbreak in 2006 and the Acanthamoeba keratitis outbreak in 2007. After these outbreaks, the Food and Drug Administration (FDA) convened a meeting of the Ophthalmic Advisory Committee in 2008 to explore ways to enhance contact lens safety, to prevent further infectious outbreaks. The need to incorporate “real-world” consumer use into microbiological tests for contact lens care products and to develop a consensus disinfection efficacy protocol for Acanthamoeba was recommended at the 2008 ophthalmic advisory panel meeting. In 2009, the American Academy of Ophthalmology (AAO), the American Academy of Optometry (AAOpt), the American Optometric Association (AOA), the Contact Lens Association of Ophthalmologists (CLAO), and the FDA jointly sponsored a workshop aimed at determining the appropriate parameters to better assess the antimicrobial effectiveness of contact lens care products. At the 2009 microbiology workshop, consensus was reached on a few Acanthamoeba protocol parameters, with research to further develop disinfection methodology, including test method development for Acanthamoeba disinfection efficacy tests, continuing thereafter. However, consensus methodology has not been developed to date. A subsequent Ophthalmic Advisory Committee meeting in May 2014 convened to inform potential modifications to FDA’s 1994 and 1997 guidance documents for contact lenses and accessories, respectively. The experts on the advisory panel suggested the following modifications to the FDA guidance: future novel lens technologies be assessed with respect to the silicone hydrogel lens grouping system, education and clear labeling be provided to patients regarding potential adverse interactions of lens materials with care product solutions, the relevance of the organisms recommended for testing in International Organization for Standardization (ISO) 14729 and the 1997 FDA guidance document be evaluated and potentially updated to include testing of care product solutions against emerging pathogens (Table 1), and ocular soil used in disinfection efficacy testing be better defined. With the subsequent rise in the number of Acanthamoeba infections, the development of relevant test methods for assessment of the safety and effectiveness of care product solutions in conjunction with continuing patient education regarding the proper use of contact lenses and accessories is of utmost importance. Therefore, to address recommendations made with respect to microbiology, the FDA, AAO, AAOpt, AOA, and CLAO jointly sponsored the September 2014 workshop entitled “Revamping Microbiological Test Methods for Contact Lenses, Products, and Accessories to From the Office of Device Evaluation (D.H., M.E.T., M.E.), Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland; Boston Foundation for Sight (D.S.J.), Needham, Massachusetts; Department of Ophthalmology and Visual Sciences (L.S.-F., T.S.), Case Western Reserve University, Cleveland, Ohio; Division of Ophthalmology (T.S.), MetroHealth Medical Center, Cleveland, Ohio; Department of Ophthalmology (D.D.), UPMC/University of Pittsburgh Schools of the Health Sciences, Pittsburgh, Pennsylvania; American Optometric Association (M.R.D.), St. Louis, Missouri; and Department of Ophthalmology and Visual Sciences (B.H.J.), University of Maryland School of Medicine, Baltimore, Maryland. Participant and nonfederal authors’ travel was provided by the four cosponsoring organizations. L. Szczotka-Flynn: Pending grant support from Alcon and Johnson & Johnson Vision Care. D. Dhaliwal: Grant Support from 11 Therapeutics, Avedro, and AMO. The remaining authors have no funding or conflicts of interest to disclose. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services (DHHS). Address correspondence to Malvina Eydelman, M.D., 10903 New Hampshire Ave, Silver Spring, MD 20993; e-mail: malvina.eydelman@ fda.hhs.gov Accepted September 2, 2015.

Orthokeratology: Does it Live Up to Expectations?

VERNIGHT ORTHOKERATOLOGY IS A TECHNIQUE for correcting myopia and is more recently proposed for the prevention of myopic progression. It is potentially an alternative to laser in situ keratomileusis and may be offered to parents whose children are not candidates for refractive surgery and who are searching for an intervention that may lessen or ameliorate developing myopia. In this issue of the Journal, Koffler and Sears present a comprehensive review of overnight orthokeratology. 1 Clinical and theoretical issues remain, however, and this editorial will attempt to add perspective. Overnight orthokeratology works to correct myopia by flattening the cornea through a mechanism of central epithelial thinning. The corneal periphery becomes thicker, thereby enhancing the peripheral corneal curvature. Good vision is possible by 1 week, stabilizing by 1 month. Treatment effects appear to be transient unless retainer lenses are worn every 1-2 nights to maintain the flattening effect. 2 Overnight orthokeratology clearly alters the structural integrity of the epithelium. Following overnight orthokeratology, the central epithelium displays significant changes in the shape and size of apical cells. 3 These cells may lose the normal microprojections (plicae) that are absent in deeper layers. Animal models demonstrate increased adhesion of pseudomonas to surface cells, accompanied by thinning and reduced turnover of the epithelial complement. These factors, plus the compressive lens effect, may render the cornea more susceptible to microbial invasion. 4 Nieto-Bona and associates demonstrated that stromal keratocyte density is maintained and there are no endothelial cell density changes after 1 month to 1 year, but at 1 year polymegethism increased significantly and did not recover to baseline. 3 The Food and Drug Administration (FDA) granted approval to 2 overnight orthokeratology lenses in 2002. Paragon (Grand Rapids, Michigan, USA) was approved for 6.00 spherical and 1.75 cylindrical correction. Euclid Systems (Bausch and Lomb, Rochester, New York, USA) was approved for 5.00 and 1.50, respectively. The Paragon premarket study included 218 subjects (and only 12 adolescents).The FDA Advisory Panel recommended approval for patients aged 18 years and older unless further safety data for younger eyes became available. No adolescents were studied in the Euclid Systems cohort. No cases of serious microbial keratitis were reported, but 1 infiltrate was treated. There were no cases of permanent vision loss. The FDA did not endorse the Advisory Panel recommendations and granted overnight orthokeratology approval without age restriction, stating there were no additional safety issues for adolescents as long as the lenses were used according to the approved labeling and were fit only by trained practitioners. 5 Overall, 11% of the premarket study cohort comprised adolescents aged 12-17 years old. 6 However the market for adolescents may be much larger. 7 A recentsurvey of overnightorthokeratology indicates fits represent 28% of all contact lenses prescribed

Ocular loiasis in Ohio: a case report

Loiasis, a systemic infection with the parasitic nematode Loa loa endemic to wet regions of western and central Africa, can present several years after a patient’s last exposure to the vector fly Chrysops sp. [1]. Though prevalent in countries such as Cameroon, Gabon, and Nigeria, it is considered an extreme rarity in the USA and other Western countries [2–5]. A classic clinical finding is that of ocular pain, redness, foreign body sensation, and a visible, motile worm in the subconjunctival space. We present here a case of ocular loiasis diagnosed in Cleveland, OH, in an immigrant who last visited his native country of Cameroon 5 years prior to presentation. Case

Micobiological testing for contact lens care products-public workshop: FDA white oak conference center, Silver Spring, Maryland.

As a Contact Lens Association of Ophthamologists and American Academy of Ophthamology representative it was an honor and a pleasure to be a part of this auspicious and historic meeting.1,2 No longer will Acanthamoeba keratitis be regarded as “a train wreck in slow motion”3; we have responded to Cavanagh’s exigent appeal, and we witness the beginning of a transformation of consensus into evidence-based standards for the contact lens industry. The U.S. Food and Drug Administration’s (FDA) Microbiology Testing for Contact Lens Care workshop was held at the FDA’s White Oak Conference Center, on January 22 to 23, 2009. Nearly 100 conferees attended a meeting which attempted to build consensus on issues raised during a hearing before the FDA’s Ophthalmic Devices Panel (June 10, 2008).4 This followed two outbreaks of contact lens related (“atypical”) keratitis (Fusarium, Acanthamoeba), which were reported by the Centers for Disease Control in 2006 and 2007.5,6 Both outbreaks were linked to multipurpose disinfecting solutions.7 Subsequently, we learned that contact lens-related fungal keratitis had actually been increasing for several years before 2006.8 Despite a product recall in 2007, there has not been a steep decline in Acanthamoeba keratitis cases.9 Moreover, despite technologic advances in contact lens care products over the past 20 years, there has been little substantial improvement in the rate of microbial keratitis among contact lens wearers.10 The purpose of this preclinical workshop was to develop additional guidance for contact lens care products. There were numerous presentations from leaders in the field: university researchers, consultants, as well as representatives from industry and regulatory agencies. The program was cosponsored by the FDA, American Academy of Ophthamology, Contact Lens Association of Ophthamologists, American Optometric Association, and the American Academy of Optometry. The format combined presentations and break-out sessions where participants were encouraged to freely discuss and problem solve disinfectant test methodology. Currently, there is no standard protocol for efficacy testing of lens disinfectants against Acanthamoeba. Therefore, the goal was to reach consensus on critical test methods and parameters in this evaluation. These parameters included organism species and strain, trophozoite culture and cyst production, microbial challenge level, and assay method for survivors. The meeting also discussed the development of test methods to investigate efficacy of multipurpose solutions under “real-world” conditions. During the two outbreaks (2006–2007), some eye care professionals expressed concern that the FDA had not thoroughly tested solutions under conditions in which many patients had actually used them.11 The workshop attempted to discuss and develop performance criteria and disinfectant efficacy test methods that simulate consumer use conditions. These elements include contact lens and lens case uptake of preservative and other excipient ingredients, solution evaporation, biofilm formation, and clinical isolates as challenge organisms. Discussion questions guided the debate:

Tinted sports performance lenses: "Will everyone please play by the rules?"

The new year brings new opportunity and new challenges to the contact lens industry and to us as eye care professionals. This year we will all undoubtedly hear about Bausch & Lomb’s “performance-enhancing” tinted soft contact lens (MAXSIGHTTM) approved by the FDA in 2005 and introduced last summer after Bausch & Lomb’s marketing agreement with Nike. The lens is designed for athletes engaging in outdoor sports. The lens selectively filters blue and red wavelengths and reduces glare to provide the wearer with enhanced clarity of vision. Amber lenses absorb yellow wavelengths and allow the wearer to see the ball better in fast-moving sports (e.g., baseball, softball, soccer, tennis, and football). Gray-green lenses are intended for bright sun activities, including golf and running. The wearer has reduced reflection and glare, improved field of view, elimination of prismatic effect (ametropes), and of course elimination of frames which can make sunglasses undesirable during active sports. The downside to the wearer is that the tinted lenses cannot be removed as easily or as quickly as sunglasses. The usual lens care responsibility and risk of inflammation or infection are important features for the casual (or contact lens–naive) wearer and athlete to understand. Marketing surveys indicate that perhaps 75% of the performance contact lens market is plano. Obviously, this figure represents a new opportunity for the contact lens industry and for us as eye care professionals: the ability to attract first-time or infrequent contact lens wearers. If marketing data are accurate, this will again attract new wearers in the teenage and young adult crowd, particularly young men. It is the young male demographic coupled with the plano lens that concerns me. Despite the availability of these lenses only through licensed eye care professionals, could plano sports lenses fall into the black market? Plano “decorative” lenses sold “over the counter” proved to be a threat to eye health in teens and unsuspecting young adults.1,2 Blinding infections from Pseudomonas and Acanthamoeba have been reported and include vision-threatening infections requiring hospitalization and even corneal transplantation. These reports led to a legislative enactment amending the Food Drug and Cosmetic Act: “All contact lenses, regardless of intended use, are medical devices.”3 The legislation (S172) championed by Senator Mike DeWine (R-OH) and U.S. Representative John Booze (R-AR) was signed into law (#109-96) by President Bush on November 9, 2005 and covers all lenses (including, presumably, plano sports lenses). Nevertheless, could some of these lenses be obtained through overseas mail order or Internet sales? In Canada, non–visioncorrecting lenses have been deregulated for over-the-counter sales, so it is perfectly legal to obtain any plano lens without a prescription and fitting from an eye care professional. Many questions remain unanswered. Will sporadic wearers use the lenses responsibly? Will they wear them only during the sporting event and not continuously, risking visual contrast problems in low lighting and darkness and risking hypoxic stress to the cornea if overworn? The dK of this lens is only 8.4. Will wearers practice sanitary lens handling? Will they be able to safely remove and store the lenses during a sporting event? Will they have backup lenses available? Will they properly clean and store the lenses? Should the frequency of lens case cleaning and replenishment of multipurpose disinfecting solution be changed? Will some sports enthusiasts expand the wear time to include wear while swimming, water skiing, or in hot tubs? Will some wearers experience a sucked-on lens? Only one base curve, 8.7, is available. Will wearers practice risk-taking behavior? This was repeatedly shown in two published series.1,2 Lenses were overworn; saliva was used as a wetting agent; and users failed to clean and replace their lenses properly. Lenses were frequently shared with friends. Wearers got into trouble because they failed to treat these lenses as seriously as vision-correcting lenses. Another series has shown complications of plano decorative lenses even when prescribed by eye care professionals.4 One of the conclusions speculated on a more casual attitude of the wearer. Reports of football team trainers distributing these lenses to the team are already surfacing. Will proper instruction be given? Division of Ophthalmology, MetroHealth Medical Center, 2500 Metro Health Drive, Cleveland, OH 44109-1998.

Severe penetrating ocular injury from ninja stars in two children

The authors describe two cases of penetrating ocular trauma in children resulting from ninja stars. In the first case, despite a scleral laceration, loss of iris tissue, and a vitreous hemorrhage, the child had a good result with a final best corrected visual acuity of 20/20. Unfortunately, the child in the second case did not fare as well. In this case, the child suffered a large corneal laceration and traumatic cataract. He ultimately required a penetrating keratoplasty, and he is currently being treated for amblyopia, strabismus, and elevated intraocular pressures. His best corrected visual acuity is 20/70.