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LASIK | Legal | Meibomian Gland Dysfunction | Corneal Collagen Crosslinking
 

3/15/2017

FDA Study Addresses Post-LASIK Satisfaction
In a recent series of observational studies called for by the FDA, researchers used a questionnaire to better understand patient-reported issues with laser in situ keratomileusis (LASIK) surgery, including the frequency of visual and dry eye symptoms, satisfaction with vision and overall satisfaction with the surgery.1

While the safety and efficacy of LASIK have been well documented, reports of dry eye symptoms, problems with vision postoperatively and general dissatisfaction with results still exist, prompting the Patient-Reported Outcomes with LASIK (PROWL) questionnaire study. Researchers surveyed two groups of patients throughout their LASIK experiences: PROWL-1, which consisted of active-duty Navy personnel ages 21 to 52 from a single military center, and PROWL-2, which consisted of civilians ages 21 to 57 from five private practices and academic centers.

Although results were generally favorable, 28% of patients who had normal Ocular Surface Disease Index (OSDI) scores at baseline ended up with mild, moderate or severe dry eye symptoms at three months post-surgery. Although the total amount of visual symptoms and dry eye symptoms decreased from pre-surgery to post, 43% of PROWL-1 and 46% of PROWL-2 reported new visual symptoms three months after surgery. Additionally, 1% to 4% of patients were dissatisfied with their vision, and 1% to 2% were dissatisfied with the surgery overall.

“What’s surprising is the fact that preoperative OSDI results don’t correlate well with postoperative ODSI score,” says Clark Chang, OD, director of Clinical Services at TLC Vision and director of Cornea Specialty Lenses at Wills Eye Hospital Cornea Service in Philadelphia. According to Dr. Chang, this could stem from discord between clinical signs and patient symptoms in dry eye, the lack of a definitive clinical test to diagnose dry eye and postoperative dry eye being induced by something separate from the current clinical understandings.

Despite the number of patients who developed new visual symptoms postoperatively, only a few actually reported any kind of significant lifestyle impact. Still, conclusions from the study encourage doctors to counsel prospective LASIK patients about the possibility of postoperative visual symptoms.

The questionnaire is a step in the right direction towards a greater understanding of the risks associated with LASIK. “Patients and health care providers now have a well-defined tool to guide medical decisions and future research,” says Malvina Eydelman, MD, director of the Division of Ophthalmic and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health. “By continuing to listen to the patient’s perspective during the development, evaluation and use of medical devices, the FDA and manufacturers can work together to better assure that LASIK devices marketed in the United States address patients’ needs.”

1. Eydelman M, Hilmantel G, Tarver ME, et al. Symptoms and satisfaction of patients in the patient-reported outcomes with laser in situ keratomileusis (PROWL) studies. JAMA Ophthalmology. 2017;135(1);13-22.

Legal Changes in the Air
It’s been a combative time as various groups push back against challenges to contact lens distribution, citing potential safety risks. Here’s a review of the recent trends, news and nail-biters:

UPP Battle. In the wake of 1-800 Contacts’ victory in Utah, Johnson & Johnson Vision Care, Alcon and Bausch + Lomb have since reevaluated their policies. Johnson & Johnson discontinued the practice of UPP for its CL products in April 2016, and Alcon followed suit in December 2016 days after a federal appeals court allowed Utah’s anti-price fixing law to remain in effect.1 Bausch + Lomb was the last to fold, finally ending it’s UPP practice just last month.2

FCLCA Changes. 
The recent Contact Lens Consumer Health Protection Act of 2016 (S.2777) would amend the Fairness to Contact Lens Consumers Act (FCLCA) of 2004 by adding patient safety requirements and increased accountability for the online contact lens sales industry. The companion bill, H.R. 6157, would modernize prescription verification and clarify consumer protections regarding false advertising. It would disrupt the “robocalls” and other illegal sales tactics, says Joseph P. Shovlin, OD, of Scranton, Pa. “It requires that lenses be prescribed exactly as ordered from the prescriber and increases infraction fines to $40,000.”

Contact Lens Rule Overhaul. The comment period for the FTC’s proposed changes to the Contact Lens Rule—which would require eye care practitioners to obtain a signed acknowledgement from patients after receiving a prescription—ended January 30, with more than 4,000 commenters.3,4

While Johnson & Johnson Vision Care, the AOA and the Coalition for Patient Vision Care Safety drafted formal comments opposing the proposed changes, one comment signed by the attorneys general of 20 states suggests the proposed change is, in part, intended to “empower consumers to comparison shop for contact lenses, and to spur more competition.”4,5

Competition Lawsuits. In August 2016, the FTC sued 1-800 Contacts, alleging that it unlawfully entered into bidding agreements with at least 14 competing online contact lens retailers that eliminate competition in auctions to place advertisements on the search results page generated by online search engines.6 The agreements could restrict truthful and non-misleading internet advertising to consumers, resulting in some consumers paying higher retail prices for contact lenses.6

1. Alcon. Unilateral Pricing Policy. Available at www.alcon.com/content/unilateral-pricing-policy.
2. Bausch + Lomb ends unilateral pricing policy. Vision Monday. February 13, 2017.
3. Contact Lens Rule. Federal Register. Available at www.federalregister.gov/documents/2016/12/07/2016-28471/contact-lens-rule.
4. 20 State AGs among 4,000 ‘commenters’ to FTC over proposed changes to contact lens rule. Vision Monday. February 24, 2017.
5. Johnson and Johnson Vision Care. Make Your Voice Count Today: Why FTC Need to Hear from You. Available at www.jnjvisioncareinfo.com.
6. Federal Trade Commission. FTC sues 1-800 Contacts, charging that It harms competition in online search advertising auctions and restricts truthful advertising to consumers. August 8, 2016.

In Brief 
A recent study of meibomian gland dysfunction (MGD) suggests a new, modified MGD classification based on both the morphology and function of meibomian glands. Meibomian gland function is generally evaluated by lipid layer thickness and meibum quality and expressibility, while its morphology is evaluated using meibography to detect gland dropout. The international MGD workshop classified MGD as one of three subtypes: hypersecretory, obstructive or hyposecretory, the researchers note. However, meibomian gland function and morphology are not necessarily correlated, and many patients have characteristics of more than one subtype. Because of this, researchers suggest a mixed subtype—as is used in dry eye classification to describe one of the most prevalent categories of dry eye patients—be added to the MGD classification to more accurately describe these patients.

Kim HM, Eom Y, Song JS. The relationship between morphology and function of the meibomian glands. Eye Contact Lens. October 13, 2016. [Epub ahead of print].

The long-term effects of corneal collagen crosslinking (CXL) may be more daunting than we think, according to new research. Investigators used a rabbit model to test corneal fragility—defined as any material that cannot tolerate a large variation in shape—immediately after CXL and at day one, three, seven and 28 post procedure. The results show corneas treated with UVA/riboflavin CXL, while more rigid, are also more fragile compared with untreated eyes. The researchers also found the different CXL protocols that call for differing exposure may have variable effects on the corneal fragility. There is a dearth of information on the clinical significance of corneal fragility after CXL, the researchers said in the study. However, corneal fragility should be a concern for practitioners, given that corneal fragility increases with age and is often an issue for patients with keratoconus. In addition, the researchers note that corneal fragility is an especially important factor for contact lens wearers, as corneas with less sensitivity and more fragility are more prone to infection and superficial scarring after wearing contact lens. These new findings emphasize the need for a closer look at the long-term implications of CXL on corneal fragility, the researchers conclude.

Li Z, Yumeng Wang Y, Xu Y, et al. The evaluation of corneal fragility after UVA/riboflavin crosslinking. Eye Contact Lens. 2017 Mar;43(2):100-2.


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