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Patient Education and Literacy
The National Adult Literacy Survey of 1992 revealed that nearly one-fourth of the American adult population is functionally illiterate.1 One decade later, over 19,000 adults representing the entire population aged 16 and older, from all 50 states and the District of Columbia, participated in the national and state-level assessments. A key finding of the survey was no significant improvement in prose literacy (ie, the skills needed to search, comprehend, and use continuous texts like editorials, news stories, brochures, and instructional materials) or document literacy (ie, the skills needed to search, comprehend, and use discontinuous texts in various formats like job applications, payroll forms, transportation schedules, maps, tables, and drug or food labels) between the 1992 and 2003 participants. In both testing years, on average, Americans scored 275 (prose literacy) and 271 (document literacy) out of a possible 500.2

The prevalence of inadequate health literacy, or a patient's inability to comprehend written material in a health care setting, is a concern for the medical community.3 In one study involving more than 2,500 patients in two urban hospitals, 42% of subjects could not understand written instructions for taking medication on an empty stomach.4 In a study of the association between age and health literacy among elderly persons, Baker et al found that functional health literacy is lower in older age cohorts compared with younger cohorts in the United States.5 In a sample of English-speaking adults aged 60 years and older, fewer than 20% demonstrated adequate health literacy skills.3

With the ever-increasing volume of refractive cataract and laser procedures, the need for effective patient education and sound informed consent is critical. Cataract & Refractive Surgery Today contacted members of the ophthalmic community to find out how a patient's competency influences patient education and the informed consent process.

To meet the needs of patients of all literacy levels, Uday Devgan, MD, believes that it is important to present information in "more than one format." Dr. Devgan is in private practice in Los Angeles, the chief of ophthalmology at Olive View UCLA Medical Center, and an associate clinical professor at the UCLA School of Medicine. "Prior to an office visit we send the patient a copy of my book, Cataract Surgery: a Patient's Guide to Cataract Treatment (2009), which is written in very simple English and aims to accommodate an average adult literacy reading level. It is relatively short (120 pages), the text is enlarged, and includes easy-to-follow illustrations," Dr. Devgan wrote in an e-mail to CRSToday.

To supplement the information in his book, Dr. Devgan's patients are shown a video and computer simulation modules by an ophthalmic technician during their office visit. When a patient meets with the surgeon, he or she spends time answering the patient's questions and reinforcing the material presented in the book and the video and simulation modules. "We have found that this multidimensional education process ensures that patients of all competency levels have a solid understanding of their condition and treatment options so that they can make an informed decision about their health care," Dr. Devgan wrote.

Like Dr. Devgan, Lisa Brothers Arbisser, MD, employs video as a patient learning tool. "I produced my own consent video for cataract surgery in which I educate the patient and family about cataracts, cataract surgery, and visual rehabilitation," Dr. Arbisser told CRSToday. "This includes risks and benefits, anatomy, the elective nature of cataract surgery timing, their responsibility to follow postoperative care, refractive error, astigmatism, and presbyopia correction, including accommodative and multifocal IOL technology." Patients have the option of receiving and viewing the video at home prior to their office visit or while dilating during an examination. Dr. Arbisser offers a copy of the video for the patient to keep as well, she said. A transcript is available for patients who require translation or who are hearing impaired. Dr. Arbisser is in private practice with Eye Surgeons Assoc. PC, located in the Iowa and Illinois Quad Cities, and she is a clinical adjunct associate professor at the John A. Moran Eye Center of the University of Utah in Salt Lake City.

Although the video is a useful way to educate patients, Dr. Arbisser believes that it is her responsibility to verify what they understand about their condition and treatment options as well as clarify what patients do not understand before they sign a consent form. "Patients have the actual consent form explained, and it is sent home to review before signing," she said. "We also have the patient sign a form confirming their refractive choice (aim for distance, near, or both and addressing astigmatism treatment or not) so that there is no confusion." If Dr. Arbisser feels that discussions have not been effective, she seeks out a relative or a power of attorney, if the patient allows. "I will not initiate treatment until I am confident that the patient understands the form that he or she is asked to sign," she said

Marguerite McDonald, MD, is a cornea/refractive/anterior segment surgeon with the Ophthalmic Consultants of Long Island in Lynbrook, New York, and a clinical professor of ophthalmology at NYU School of Medicine in Manhattan. She wrote to CRSToday that a patient's literacy, verbal skills, and educational levels are usually apparent within the first 2 to 3 minutes of the encounter. Dr. McDonald educates all of her patients—regardless of their literacy level—with print and Web-based materials as well as face-to-face discussions of the proposed sugery/disease. Dr. McDonald has found that illiterate patients have friends and relatives who are willing to read the materials to them. She also spends extra time during the in-person preoperative informed consent/diagnosis discussion with patients who seem less likely to read the materials or view the suggested Web site. "I usually draw a picture of the diagnosed condition and proposed surgery as well as give the sketch to the patient to take home as a memory cue from our conversation," she commented. "Also, in the case of a patient who is not making their own medical decisions, such as a minor or an elderly person, I speak to the patient's adviser."

Patient literacy is as much a class issue as a social issue, Dr. McDonald pointed out. "There are very few illiterate patients who are successful enough to pursue elective refractive surgery," she stated. "They are more likely to pursue insurance-covered cataract surgery." Patients who do not speak English represent the most prevalent literacy issue that Dr. McDonald faces. "I do not assess patients' literacy levels in a formal fashion, but it is common to encounter patients who pretend to speak English fluently out of embarrassment," she noted. "If I think that is the case, I immediately call a translator into the room. We also have informed consent materials and handouts in Spanish and hope to have other languages soon."

Oculus Introduces Lower-Priced Pentacams
Oculus, Inc. (Lynnwood, WA), expanded its Pentacam portfolio to include five models, three of which are priced lower to accommodate ophthalmologists' specific clinical and financial needs.

All five units come with a basic software package, which includes Scheimpflug imaging, color refractive and topometric maps, the ability to compare examinations, tomography, keratometry readings, noncontact pachymetric measurements, anterior chamber depth measurements, and the angle in degrees. The less expensive models—the Pentacam Basic, the Pentacam Basic plus refractive software, and the Pentacam Basic plus cataract software—come with a laptop, and optional modules may be added. Software upgrades are also available for these models. The more expensive Pentacam Classic and Pentacam High Resolution are packaged with additional software, have a variety of optional modules, and include numerous hardware features such as a motorized table, a flat-screen monitor, a personal computer, a wireless mouse, and a mini keyboard.

Please e-mail sales@oculususa.com or call (888) 284-8004 toll free for additional information.

AMO Suspends Production of Healon D
Abbott Medical Optics Inc. (AMO; Santa Ana, CA) has suspended the manufacture of Healon D. The product's manufacturing process limits AMO's ability to ensure a continuous supply of this ophthalmic viscosurgical device (OVD) to the market to meet customers' needs and avoid delays and backorders, Steve Chesterman, a spokesman for AMO, wrote in an e-mail to Cataract & Refractive Surgery Today.

The company's action does not pertain to Healon D that has already been distributed to customers, only to future production. The manufacture of AMO's other Healon products will not be affected, Mr. Chesterman said. The company will continue to pursue offering a dispersive OVD to US-based customers and will continue to provide Healon, Healon GV, and Healon5 globally. AMO's Vitrax II dispersive OVD will remain available in Canada, Europe, and other select global markets.

Alcon to Complete Acquisition of WaveLight AG
Alcon, Inc. (Huenenberg, Switzerland), announced that the company has achieved ownership of more than 95% of the share capital of WaveLight AG (Erlangen, Germany). Under the provisions of the German Stock Corporation Act, Alcon is deemed to be the principal shareholder of WaveLight's approximately 6.6 million issued and outstanding shares. Alcon intends to acquire all remaining outstanding shares in accordance with the "squeeze-out" provisions of German securities law. Under these provisions, shareholders owning at least 95% of a company's shares have the right to "squeeze out" the remaining minority of shareholders by compensating them adequately. Alcon intends to acquire the remaining shares following WaveLight's annual general meeting, which is to be held in August.

B&L Boosts Crystalens With Money-Back Guarantee
Bausch & Lomb (Rochester, NY) is offering a money-back guarantee for Crystalens patients. According to a company news release, the offer applies to bilateral implantation of the Crystalens. In order to qualify, however, at least one eye must be implanted with the Crystalens HD. Also, both procedures must be performed in the United States or Puerto Rico from April 13, 2009, through September 30, 2009.

Eligible patients will be entitled to a reimbursement of up to $2,500 per eye if, at their 9-month postoperative examination, they have not achieved an uncorrected binocular visual acuity of 20/40 or better in at least two of three ranges of vision (near, intermediate, and distance). In addition, the surgeon's preoperative refractive targets must have been achieved within ±0.50 D, and neither eye may be left with more than 0.75 D of astigmatism.Ê

The offer is limited to patients with bilateral cataracts and no preexisting eye disease or prior corneal refractive surgery. Also, the guarantee does not apply to complications associated with cataract surgery.

Participating surgeons must agree that they will not advertise the guarantee outside of their offices. Those who wish to offer the money-back guarantee to their patients must register with Bausch & Lomb and be credentialed by the company to implant the Crystalens.

For information about how to participate in the Crystalens money-back guarantee, contact a Bausch & Lomb representative or call (949) 916-9359.

Hoya Corporation Appoints Head of Surgical Optics Division
Hoya Corporation (Tokyo, Japan) announced that Thomas A. Dunlap, MBA, has been appointed to the position of global president and chief executive officer of Hoya Surgical Optics, Inc. (Chino Hills, CA), which entered the US market during the first quarter of 2009.

Mr. Dunlap has been a senior operating executive and leader in the ophthalmic industry for more than 30 years. He has held executive positions at American Hospital Supply Corporation (Maitland, FL), Allergan, Inc. (Irvine, CA), and Bausch & Lomb (Rochester, NY). Most recently, he was the executive vice president of Sand Hill Consulting Associates (Santa Rosa, CA). Mr. Dunlap was instrumental in the lobbying efforts of the Intraocular Lens Coalition, which led to the establishment of the New Technology Intraocular Lens (NTIOL) designation for high-technology lens implants.

Inspire Tests AzaSite for Blepharitis
Inspire Pharmaceuticals, Inc. (Durham, NC), initiated a phase 2 program to evaluate AzaSite (azithromycin ophthalmic solution 1%) for the treatment of blepharitis. AzaSite is a topical ophthalmic prescription drug currently approved by the FDA for the treatment of bacterial conjunctivitis. According to a company news release, the phase 2 program consists of two randomized, placebo-controlled, multicenter trials to evaluate the safety and efficacy of 2 versus 4 weeks of treatment with AzaSite compared to placebo. Both trials include approximately 300 participants with blepharitis. The results from both trials are expected in the first half of 2010.

Allergic Conjunctivitis Symptoms Reduced With Bepreve
Bepreve (bepotastine besilate ophthalmic solution; Ista Pharmaceuticals, Inc., Irvine, CA) significantly reduced ocular itching, according to a news release. In two 7-week, phase 3, masked, randomized, placebo-controlled studies, the conjunctival allergen challenge model was used to investigate the efficacy of Bepreve versus placebo in 157 subjects with allergic conjunctivitis. When dosed in both eyes, Bepreve 1.5% reduced ocular itching for at least 8 hours after dosing and was statistically superior to placebo in reducing ocular itching when conjunctival allergen challenge tests were administered 15 minutes, 8 hours, and 16 hours after dosing (P<.0001).

Tamsulosin Significantly Associated With Adverse Events After Cataract Surgery
A new study suggests that, in addition to causing surgical complications due to intraoperative floppy iris syndrome (IFIS),1 tamsulosin (Flomax; Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT) increases patients' risk of developing serious postoperative complications following cataract surgery.2 Tamsulosin is an alpha-adrenergic receptor blocker indicated for the treatment of benign prostatic hyperplasia.

An analysis of 96,128 men undergoing cataract extraction between 2002 and 2007 identified 284 (0.3%) patients who experienced an adverse event within 14 days postoperatively. Of the patients who experienced complications, 100 had suspected endophthalmitis. In addition,175 patients underwent procedures to retrieve a lost lens or lens fragment from the vitreous body, 35 to resolve a retinal detachment, and 26 to address both of these adverse events.

When the investigators matched 280 of the 284 patients who experienced adverse postoperative events with 1,102 control patients, they found that those who used tamsulosin were 2.3 times more likely to develop serious postoperative complications than those who were not exposed to the drug preoperatively. The investigators did not observe an increased risk of complications when nonselective alpha-blockers (eg, alfuzosin, doxazosin, and terazosin) were used.

"This is an interesting study conducted in the province of Ontario, Canada," wrote David F. Chang, MD, in an email to Cataract & Refractive Surgery Today. Dr. Chang is a clinical professor at the University of California, San Francisco, and is in private practice in Los Altos, California. "Because the province's universal health care system covers medications, the investigators were able to capture every surgical procedure and every prescription drug that was filled. Bell and colleagues found that patients taking tamsulosin had a 2.3 times higher incidence of serious postoperative complications. It should be noted that the study period includes surgeries done both before and after the initial description of IFIS."

"This is the first paper on IFIS to be published in the general medical literature," Dr. Chang added. "Although it is obvious to ophthalmologists that postoperative complications are more likely following posterior capsule rupture, primary care physicians do not really understand what this means. Specifically documenting Ôretinal detachment, lost nuclear fragments, and endophthalmitis' as complications of tamsulosin/cataract surgery will better impress primary care physicians about the seriousness of this drug's side effects in cataract patients. These published findings may also encourage prescribing doctors to favor nonselective alpha-blockers in patients with a cataract."

Dry Eye Symptoms May Indicate Thyroid Eye Disease
In the early stages of thyroid eye disease, patients often present with dry eye symptoms. According to researchers at the Wilmer Eye Institute in Baltimore, the presence of dry eye with conjunctival injection and chemosis overlying the rectus muscle may suggest that thyroid eye disease is an underlying etiology.1

Investigators retrospectively reviewed the medical records of 539 patients who presented with dry eye symptoms and were referred to the Wilmer Eye Institute's Ocular Surface Diseases and Dry Eye Clinic from January 2004 through January 2006. Of these, 21 patients (median age, 57 years) were diagnosed with occult thyroid eye disease based on findings from orbital echography. Notably, these patients did not present with the typical symptoms of occult thyroid eye disease such as proptosis, dysmotility, or diplopia.

Upon examination, the researchers observed conjunctival hyperemia with or without chemosis localized to extraocular muscles in all 21 (100%) patients and subtle widening of the interpalpebral fissure in 10 (48%) patients. Clinical findings included corneal fluorescein staining in 12 (57%) patients, rapid tear breakup time in seven (31%) patients, and an abnormal Schirmer test in four (19%) patients. Four (19%) patients had other rheumatologic disorders commonly associated with dry eye, including Sjšgren's syndrome (n = 3) and rheumatoid arthritis (n = 1).

Patients were treated with topical cyclosporine 0.05% two to four times per day, with or without a steroid. Warm compresses, artificial tears, and punctal plugs were used as needed. Symptoms improved in 16 (76%) patients, according to the investigators.

Drug Candidate for Herpes Keratitis of the Eye to Begin Preclinical Testing
NanoViricides, Inc. (West Haven, CT), signed a preclinical study agreement for the evaluation of the company's drug candidate for herpes keratitis of the eye, according to a news release. Thevac, LLC, a spin-off of Louisiana State University (LSU) in Baton Rouge, will conduct the study in collaboration with the Division of Biotechnology and Molecular Medicine at the LSU School of Veterinary Medicine, which administers the LSU-Tulane Center for Experimental Infectious Disease Research.