at press time

New E-mail Initiative Helps Physicians
It Offers Secure and Private Communications.

John Jarstad, M.D., an ophthalmologist in Federal Way, Wash., has been using e-mail in his refractive surgery practice to respond to inquiries, answer basic questions, and arrange screening appointments for potential patients. Recently, he's been looking into using e-mail to schedule appointments for his nonrefractive patients.

One such partnership that shows promise was launched earlier this year. It's called HealthyEmail and brings together ZixCorp of Dallas, Texas, a leader in providing secure e-mail technology, and a nine-member advisory board representing physicians, healthcare consultants and healthcare insurers.

Physicians who join HealthyEmail also receive educational guidelines and policies on the appropriate use of e-mail, consent forms that can be signed by patients who agree to communicate via e-mail, and free technical support.

Richard Whitten, M.D., a general internist at the University of Washington Physicians Network, is a member of the HealthyEMail advisory board. Prior to the advent of HealthyEmail, he had to provide each patient he e-mailed with a different six- or eight-digit code number so that the patient could open and respond to the encrypted e-mails.

"We live in the middle of Microsoft country and have many patients who like to communicate through e-mail." says Dr. Whitten. "I can only speak for myself on this issue, but the simplified encryption process offered through HealthyEmail should encourage more doctors to use e-mail regularly as a patient communications tool."

Physicians interested in learning more about HealthyEmail can call (866) 251-4949 (toll-free), send an e-mail to info@healthyemail.org, or access the HealthyEmail Web site at www.healthyemail.org.

IN THE NEWS

Another Retisert delay. Bausch & Lomb said it faces up to a 3-year delay in filing its drug delivery implant Retisert as a treatment for diabetic macular edema (DME). Though Retisert did demonstrate effectiveness against DME, the FDA wants to see 12 months of additional safety data from a second study after 58.5% of patients in the initial Phase III trial experienced adverse side effects, including elevated IOP, cataracts and vitreous hemorrhage.

This is the second major delay for Retisert. Earlier this year, B&L said it would delay by 1 year its filing of a New Drug Application for Retisert as a treatment for posterior uveitis.

New Jersey bill withdrawn. The sponsor of proposed legislation that would have allowed New Jersey optometrists to perform laser surgery, including LASIK, has withdrawn the bill. The bill was dropped from the New Jersey State Assembly's agenda after meeting strong resistance from ophthalmologists, the media and the public.

Santen anti-infective. Santen Inc. has filed a New Drug Application for levofloxacin 1.5% ophthalmic solution, a broad-spectrum ocular antibiotic. The company says levofloxacin's higher solubility, at neutral pH, allows the active drug to be formulated at a higher concentration than other fluoroquinolones.

Santen said its levofloxacin ophthalmic solution 0.5% (Quixin) continues to gain share among ophthalmologists in the topical fluoroquinolone anti-infective market.

Therapeutic use. CIBA Vision's Focus Night & Day contact lenses have been approved by the FDA for therapeutic use. The lenses can now be used as a bandage to protect the cornea and relieve corneal pain in the treatment of acute or chronic ocular pathologies, and following eye surgery.

CIBA Vision says the lenses are ideal for therapeutic applications because they supply high levels of oxygen to the eye and can be worn continuously for up to 30 days and nights, thus requiring minimal handling.

Test Promises Early Detection of AMD
Perimetry-Based Device to be Launched.

Carl Zeiss Meditec will soon launch a novel new perimetry device for the early detection and management of AMD. The company says the device, developed by Notal Vision Ltd. of Tel Aviv, Israel, represents a major improvement in the early diagnosis of the disease.

The current standards for detecting changes in the retina resulting from AMD are periodic examinations, self-monitoring using the Amsler grid, and reports of symptoms.

In a recent demonstration, the device was called the Preferential Hyperacuity Perimeter (PHP), but it may be given a new name.

The technology for the PHP is based on the hyperacuity phenomenon, which is essentially the ability of an individual to perceive minute differences in the relative location of two or more visual stimuli. This ability isn't affected by age.

The interactive quantitative threshold visual field test, given by a technician, takes about 5 minutes for each eye. The patient and technician sit at an instrument that resembles a computer screen while the patient focuses on a white dot in the center of the screen. As the patient focuses on the dot, lines with wavy areas of different magnitudes flash briefly at different places on the screen to cover the entire macular visual field. When a line disappears, the patient uses a stylus to touch the spot on the screen where she thinks the wavy area was. The instrument then determines whether the responses are consistent with the progression of AMD.

"The instrument has high sensitivity for detecting choroidal neovascularization while the patient's visual acuity is still preserved," says a Carl Zeiss Meditec spokesperson. "It's highly sensitive for detecting even the smallest lesions."

Test results can either be stored in the instrument, printed on a color printer, or printed from the thermal printer that's part of the instrument. The screen displays a map of the macular visual field, which shows hyperacuity disturbance patterns. The instrument also provides a "results confidence" level, from low to high.

In clinical tests, the PHP was significantly superior to the Amsler grid in differentiating intermediate dry AMD from wet AMD. The PHP is expected to be a useful tool for general ophthalmologists.

VISX System OK'd for Custom Ablation
CustomVue Is Approved for Myopia, Astigmatism.

VISX has received FDA approval for its CustomVue laser correction procedure for myopia up to 6D and astigmatism to 3D. The approval is the second for wavefront-guided custom ablation in the United States, following the FDA's OK of Alcon's LADARVision system late last year. The LADARVision system received clearance for the treatment of myopia from 0.75D to 7D and less than .5D of astigmatism.

The CustomVue procedure employs the VISX WaveScan aberrometer, a diagnostic system that captures a "fingerprint" of the eye, which VISX says is 25 times more precise than what was previously measurable by standard methods.

"The results from CustomVue procedures are very impressive, with potential for sharper vision and improved night vision over contacts and glasses," says Robert Maloney, M.D., director of the Maloney Vision Institute and associate clinical professor of ophthalmology at the UCLA School of Medicine. "This technology is a significant step forward in the advancement of laser vision correction."

Clinical data presented at the American Society of Cataract and Refractive Surgery (ASCRS) 2003 meeting showed that at 1 year following the procedure, 98% of the clinical study participants could see 20/20 or better without glasses or contacts. A 6-month evaluation of study participants showed that four times as many individuals were "very satisfied" with their night vision after their CustomVue procedure, compared with their previous night vision with glasses or contacts.

"We are now moving ahead with an FDA-approved human clinical study for CustomVue procedures for the treatment of hyperopia," said Liz Davila, chairman and CEO of VISX.

See page 58 of this issue for results from the CustomVue hyperopia study presented this year at ASCRS.

IN THE NEWS

Deceased. Robert Maxwell, CEO of Fashion Optical Displays, located in Paradise, Calif., died suddenly on April 16. He was 52. Mr. Maxwell took over leadership of the company in 1985. He and his wife, Katherine, purchased the firm 3 years ago. Fashion Optical Displays will continue under the leadership of Katherine Maxwell and Ed Muehlberger.

Helen Keller Prize. Novartis Ophthalmics and QLT Inc. have received the 2003 Helen Keller Prize for Innovation in Eye Care for their development of Visudyne therapy for the treatment of wet AMD.

TTT coverage. Iridex Corporation said Medicare will now cover transpupillary thermotherapy (TTT) and feeder vessel (FV) laser protocols to treat AMD in the state of California. Iridex, which makes the OcuLight SLx used in TTT and FV treatments, said Medicare carriers now reimburse for TTT in 15 states.

Image library offered. The American Society of Cataract and Refractive Surgery (ASCRS) and the American Society of Ophthalmic Administrators (ASOA) have launched a new member service that will enable ophthalmologists to share ophthalmic photos and electronic images online. To gain access to these images, members must log on to www.ascrs.org or www.asoa.org and click on the link to the Image Library.

Stratus OCT database cleared. The FDA has cleared the retinal nerve fiber layer (RNFL) normative database for the Stratus OCT diagnostic device made by Carl Zeiss Meditec. A company spokesperson said the approval is highly significant because it "provides clinicians with a guidepost to determine how a patient's RNFL compares to a normal range."

Low-vision grant. Lighthouse International has received a $5,000 grant from the Pearle Vision Foundation to help fund a Lighthouse study that's researching new ways to help people with vision impairment retain the ability to read.

REFRACTIVE SURGERY UPDATE

Refractive groups merge. The American Academy of Ophthalmology's Refractive Surgery Interest Group and the International Society of Refractive Surgery have joined forces to form the world's largest eyecare organization solely dedicated to the advancement of refractive surgery. The combined organization will be known as the International Society of Refractive Surgery of the American Academy of Ophthalmology and will have more than 2,500 members representing about 80 countries.

STAAR ICL. STAAR Surgical has submitted the final module of its Pre-Market Approval application for its Implantable Contact Lens (ICL) to the FDA. The submission includes clinical data that fulfills the FDA's requirement for 3-year follow up. STAAR President and CEO David Bailey said the ICL phakic IOL represents the company's most significant growth opportunity.

Partnership. Lumenis has signed an extended agreement with WaveLight Laser Technologie AG of Erlangen, Germany, to serve as the exclusive representative for the Allegretto Wave excimer laser system in the United States once the product receives FDA approval. The Allegretto has already been approved for sale in a number of countries, including a recent approval in Canada.

Selected. Katana Technologies has selected the Complete Ophthalmic Analysis System (COAS) high-resolution wavefront aberrometer developed by Wavefront Sciences Inc. to provide the input to Katana's refractive surgery system.

Katana is currently developing the LaserSoft diode-pumped solid-state laser as the foundation of a system that will be capable of performing wavefront-guided refractive procedures. The companies anticipate that testing of the combined products will begin later this year.

Schwind has also selected the COAS wavefront aberrometer for use with its Esiris scanning spot excimer laser system.