As noted by this week’s abstract, the regulatory environment related to medical devices and pharmaceuticals is changing. You probably have noticed the recently proposed changes to the FTC’s Contact Lens Rule; the public’s comment period closed in late July. These changes require documentation of prescription release, clarification of the passive verification system, and subsequent substitution or modification of the prescription by the patient (and therefore seller). Time will tell, but many argue that these changes protect the consumer rather than the patient.
 

CDC Promotes Healthy Contact Lens Wear

The Centers for Disease Control and Prevention (CDC) is once again promoting its Contact Lens Health Week on Aug. 19 to 23. This year’s theme—“Contact Lens Health Starts with You”—aims to encourage eyecare providers to share healthy wear and care recommendations with their patients. Key campaign messages include improving communication about healthy contact lens hygiene habits between eyecare providers and patients, explaining the risk associated with improper contact lens use, and the importance of regular visits to an eyecare provider.

The CDC will join the American Optometric Association (AOA) for a Facebook Live on Aug. 19 at 2:00 p.m. EDT. The Facebook Live will feature Dr. Jennifer Cope, the CDC’s medical epidemiologist, and Dr. Barbara Horn, president of the AOA. The CDC will also host a Reddit AskScience chat on Aug. 20 at 1:00 p.m. EDT.

Practitioners can access free promotional materials at https://www.cdc.gov/contactlenses/contact-lens-health-week.html.
 

ABB Optical Group Now Offering Tangible Hydra-PEG on GPs in Boston Materials

ABB Optical Group announced that its specialty lens lab has been approved by Bausch + Lomb to offer Tangible Hydra-PEG surfaced coating technology in its manufacturing of GP contact lenses in Boston ES, EO, XO, and XO₂ materials.
 

Visionary Optics Updates Website, Opens New Headquarters

Visionary Optics has redesigned its website—www.visionary-optics.com—to improve the customer experience when searching for information. According to the company, the new site features a user-friendly, modern design that gives easy access to product information, videos and trainings, order forms, and industry resources.

The company also expanded its headquarters and moved to a new location in Oak Brook, IL in early August 2019. Later this year, the company plans to release a new order management platform that will be fully integrated into the new website, providing improved efficiency and order tracking for customers.
 

OcuBall Eye Model Replaces Animal-Based Methods for Foreign Body Removal

OcuBlink Inc. has shipped its first order of OcuBall, a polymer-based eye model that can be used for training and in educational settings to perfect the removal of foreign bodies while eliminating safety concerns related to handling, disposal, and storage of biological tissue.

OcuBall comes premade with carbon/mild steel particles inserted on the surface of the eye to provide a realistic, safe, and inexpensive clinical scenario for the practice of foreign body removal. Over time, the metal pieces can rust and form a typical rust ring, just as they do in the human eye.

Made of a biocompatible polymer-based material, the company says that OcuBall is less expensive compared to typically sourced animal models, and it eliminates concerns of cross-contamination and biological waste. OcuBall can be stored in saline for several weeks without spoilage and has no odor.
 

Compulink Announces Agreement to Acquire MyEyeStore

Compulink Healthcare Solutions announced the acquisition of MyEyeStore, an e-commerce solution in ophthalmic healthcare focusing primarily on contact lens re-ordering with the ability for optometry and ophthalmology practices to also sell other recommended products directly to patients.

Compulink’s all-in-one solution includes practice management, electronic health records (EHR), optical, amulator surgery center (ASC), patient portal, and ophthalmic billing services. According to the company, the addition of this e-commerce solution will allow patients to be able to order contact lenses, solutions, and any other products across all 18 specialties directly from their provider.
 

International Sports Vision Association Launches “Dynamic Visual Skills for Sports”

To help athletes of all levels, the International Sports Vision Association (ISVA), an interdisciplinary group of professionals dedicated to advancing the field of vision training, has launched “Dynamic Visual Skills for Sports,” providing an overview of some of the most relative dynamic visual skills associated with 12 sports-related areas including baseball/softball, basketball, boxing, football, golf, hockey, motorsports, skiing, soccer, sports officials, table tennis, and tennis. Other sports and areas of performance will be added soon.

The ISVA website features a “Find a Sports Vision and Performance Professional” locator at https://www.sportsvision.pro/find-a-sports-vision-performance-professional.
 

Do you believe that standard soft contact lenses used to correct myopia are associated with actual increases in myopic refractive error?

Click here to vote.

Martin Guzman, OD, Caracas, Venezuela

This photo shows a female’s right eye that has a mini scleral lens over a post-penetrating keratoplasty corneal ectasia. The image was taken using tangential illumination on a slit lamp.

We thank Dr. Guzman for this image and welcome photo submissions from our other readers! It is easy to submit a photo for consideration for publishing in Contact Lenses Today. Simply visit http://www.cltoday.com/upload/upload.aspx to upload your image. Please include a detailed explanation of the photo and your full name, degree or title, and city/state/country.
 

Is There a Demonstrable Difference in Daytime/Daily Wear Use of Soft Contact Lenses?

Over the past two decades, there has been a dramatic shift in the prescribing patterns of eyecare professionals (ECPs) toward silicone hydrogel (SiHy) lenses and away from hydrogel lenses. This is especially true for reusable lens designs and somewhat less so for single-use daily disposable (DD) lenses. The primary advantage of SiHy materials over hydrogel materials is the significantly higher oxygen permeability.

The early hope was that this increase in oxygen availability to the cornea would result in a decrease in the rates of microbial keratitis (MK), especially in extended-wear use environments. Unfortunately, outcome studies have failed to demonstrate any significant change in MK rates. In fact, reports have been published that suggest that certain SiHy lens designs may have poorer in-eye wetting and higher degrees of lipid deposits versus hydrogel lenses, and several studies showed an approximately two-times-higher relative risk of developing corneal infiltrative events with reusable SiHy lenses compared to hydrogel lenses. This has led to a certain degree of confusion and question by ECPs regarding the “need” for high-oxygen-transmission SiHy materials when lenses are worn on a daily wear (non-continuous wear) basis, especially when used as single-use/DD replacement formats.

A recent study was published that evaluated ocular physiological responses to etafilcon A multifocal (etMF) DD lenses after four weeks of wear when switching from habitual SiHy daily wear.¹ A single-arm, open-label, bilateral dispensing study was conducted in 39 habitual spherical SiHy wearers (14 hyperopes; 25 myopes). Clinical visits occurred with habitual SiHy (control) at baseline and after four weeks of etMF DD open-eye lens wear at exit. Objective limbal/bulbar hyperemia using the Oculus Keratograph 5M (0 to 4) and subjective grading of lid wiper epitheliopathy (LWE) (0 to 4) were tested for non-inferiority (NI), using a margin of 1 grade. Corneal thickness along a 10mm chord was measured using the Visante OCT (Zeiss) and tested for NI using a 30μm margin. Corneal staining area was graded (0 to 100%).

Results indicated that the least-square mean differences (LSMD) and 95% confidence interval (95% CI) between etMF DD and habitual SiHy in central and peripheral corneal thickness (μm) were 3.64 (−2.0, 9.29) and 3.0 (−7.72, 13.72) in hyperopic subjects and were 3.56 (−0.66, 7.78) and 6.40 (−1.62, 14.42) in myopic subjects. The LSMD (95% CI) for bulbar and limbal hyperemia were −0.08 (−0.19, 0.02) and −0.01 (−0.12, 0.09) for hyperopes and were 0.04 (−0.03, 0.12) and 0.04 (−0.04, 0.11) for myopes. The LSMD (95% CI) for LWE were 0.11 (−0.39, 0.60) and 0.30 (−0.07, 0.67) for hyperopes and myopes, respectively.

The authors concluded that there were no clinically significant differences in a variety of physiological responses when habitual reusable SiHy daily wear subjects were refitted into hydrogel etMF when the subjects were followed for four weeks.

Obviously, this study was limited by the short-term analysis period and significantly longer evaluation times, and other measures of physiological response (both objective and subjective) would be beneficial for future studies. However, the outcomes of this study further support our need to analyze what attributes of contact lenses have the greatest impact on our patients’ contact lens success.

Reference:
1. Moezzi AM, Varikooty J, Luensmann D, et al. The short-term physiological impact of switching reusable silicone hydrogel wearers into a hydrogel daily disposable multifocal. Clin Ophthalmol. 2019 Jul 10;13:1193-1202.
 

Another DED/OSD Formula: (FLACS) + (IOL) = (–TMH) + (–ST1) + (CFS) + (OSDI) + (SSQ)

Femtosecond laser-assisted cataract surgery (FLACS) is now an option for most patients undergoing cataract removal. Considered less traumatic and more precise compared to standard clear-corneal phacoemulsification, FLACS postoperative symptoms of eye dryness are often not obviated. A July 2019 study sheds light on this common cataract post-op patient scenario.¹

The study enrolled 38 patients (70 eyes) who had no eye signs or symptoms and who underwent FLACS and intraocular lens (IOL) implantation for age-related cataract. Tear film stability assessed with the Oculus Keratograph 5M, Schirmer’s I test (ST1), and corneal fluorescein staining (CFS) were evaluated before and after surgery at one day, one week, one month, and three months, in order. Ocular Surface Disease Index (OSDI) scores and Subjective Symptom Questionnaires (SSQs) were recorded at the same time point.

The noninvasive tear film breakup time (first breakup time and average breakup time) decreased in a peak at the one-week visit and then increased to basic levels at one month. The tear meniscus height (TMH) increased transiently at one day and declined in the following three-month visits. The ST1 had a transient increase at one day and a decrease at one week and one month, but it returned to the preoperative levels at three months after surgery. The CFS scores increased immediately after FLACS and improved gradually at three months, but they did not return to the basic levels at the three-month follow-up visit. The authors speculate that a) the peri-conjunctival injury caused by the suction ring used during femtosecond laser could contribute to damage to the limbal stem cells and conjunctival goblet cells, and b) the surgical incisions changed the smooth curvature of the corneal surface before surgery, causing irregular corneal surface damage.

The study authors conclude that eye signs and symptoms can occur immediately following FLACS and have a peak severity on day 7 postoperatively. Most signs of dry eye can return to preoperative basic levels within three months postoperatively. It is noted that not all cases can recover from CFS and dry eye symptoms at three months postoperatively.

This study is informative as we prepare our patients for post-cataract surgery expectations beyond visual acuity. Reference:
1. Ju RH, Chen Y, Chen HS, et al. Changes in ocular surface status and dry eye symptoms following femtosecond laser-assisted cataract surgery. Int J Ophthalmol. 2019 Jul 18;12(7):1122-1126.
 

Regulatory and Developmental Aspects of Biomarkers in the Treatment of Ocular Surface Disease

When treating any disease, the ideal biomarker would be a simple laboratory or clinical evaluation before treatment that would predict subsequent therapeutic response. This might include a selection of which patients might respond to that treatment. While other disciplines such as neurology and oncology have biomarkers, ophthalmology is limited to one: elevated intraocular pressure as a surrogate for progressive glaucomatous field loss. In 2016, a U.S. law required the U.S. Food and Drug Administration (FDA) to set up a system to qualify biomarkers. The system now exists, with most validated or pending biomarkers limited to safety and infection.

The American Academy of Ophthalmology selected dry eye disease as one of three diseases in which to standardize outcomes in ophthalmology research. There have been a number of biomarkers proposed for evaluating ocular surface disease and its treatment. None, however, currently meets the scientific or regulatory basis for being a valid biomarker; additional research may result in validity. And, given the FDA’s scientific basis, it is unlikely that an unproven biomarker could be used for regulatory approval, even for a “Subpart H” conditional new drug application.

Elsewhere in ophthalmology, practitioners know that even patients who share the same disease gene or mutation may differ substantially in penetrance and clinical expression. Thus, it is not unexpected that ocular surface disease—a heterogeneous disease with a variable presentation of signs and symptoms—has yet to have validated biomarkers that reach the level of evidence that allows their use for diagnosis, prognosis, therapy, and for making decisions in drug development.

Novack GD. Regulatory and Developmental Aspects of Biomarkers in the Treatment of Ocular Surface Disease. Eye Contact Lens. 2019 Jul 5. [Epub ahead of print]