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Nidek laser receives FDA OK
GAMAGORI, Japan — Nidek Co. has received approval from the Food and Drug Administration (FDA) to begin marketing and sales of its EC-5000 excimer laser for photorefractive keratectomy (PRK).
In clinical trials, the laser was found to be safe and effective for correction of myopia from 0.75 D to 13 D. Aclinical study for correction of hyperopia is under way, and Nidek will file additional applications for correction of astigmatism up to 4 D.
The company’s patented EC-5000 system uses a rotating, rectangular beam of ultraviolet light to modify the cornea.
Nidek is the first company not based in the United States to receive FDAapproval for a laser system for refractive surgery.
Nidek is the fourth company to receive FDAapproval for a laser to perform PRK, joining Visx Inc., Summit Technology Inc. and and Auton omous Technologies Corp.
B&L files, drops suit against Alcon
ROCHESTER, N.Y. — Bausch & Lomb filed a lawsuit against Alcon Laboratories, charging its competitor with using deceptive sales practices. The charges stemmed from Alcon sales representatives affixing stickers for Alcon’s Opti-Free SupraClens Daily Protein Remover to packages of Bausch & Lomb’s ReNu MultiPlus care kits, recommending that SupraClens be used with ReNu MultiPlus. According to Bausch & Lomb, SupraClens is not indicated to be used with ReNu MultiPlus or any other non-Alcon solution.
The suit was withdrawn the following day after Alcon explained that the actions of the sales representatives were not authorized by the company. Alcon also ensured Bausch & Lomb that these actions would not continue and that consumers would not receive packages with improper labeling.
Johnson & Johnson plans to overhaul Innotech
ROANOKE, Va. — Johnson & Johnson announced plans to reorganize its Innotech division, based here, to enter the spectacle lens market. By March, Innotech, acquired by Johnson & Jonson in 1997 for $135 million, will stop producing a desktop eyeglass-lens surfacing machine that had been Innotech’s only product.
Innotech is seen as a vehicle for Johnson & Johnson to enter the global eyeglass market, according to W. Ben Deibler, who was recently named Innotech’s acting president.
Sunrise submits PMA for hyperopia treatment
FREMONT, Calif. — Sunrise Technologies International Inc. reported it has submitted its premarket approval application (PMA) to the Food and Drug Administration (FDA) for the Sunrise Laser Thermal Keratoplasty (LTK) System for the treatment of hyperopia of 0.75 D to 2.5 D.
Previously, Sunrise submitted a section of a modular PMA, allowing the FDA to begin review of the application prior to the submission of the final module containing clinical data.
The Sunrise LTK is an office-based instrument that applies two rings of laser energy to the midperiphery of the cornea. Each ring is applied in 1.4 seconds and gently heats collagen in the cornea to change the shape of the cornea. No corneal tissue is cut or removed. The application of energy is accomplished without physically contacting the cornea with the instrument or other apparatus. The patient sits upright opposite the surgeon. Total chair time is designed to be less then 5 minutes.
Three more states agree to accept COPE
BETHESDA, Md. — The Council on Optometric Practitioner Education (COPE), a service of the International Association of Boards of Examiners in Optometry, has announced that the boards of optometry of Minnesota, Ohio and New Hampshire have agreed to begin accepting COPE-approved courses.
The decision of these state boards, effective immediately, brings the total number of boards of optometry that have agreed to accept COPE-approved courses to 47, including 44 states, the District of Columbia, Guam and Puerto Rico. Once a course is approved by COPE, it is automatically accepted for credit toward relicensure by these 47 participating boards.
Study: blindness from glaucoma higher than speculated
ROCHESTER, Minn. — A study in the November 1998 issue of Ophthalmology concludes that the risk of blindness from open-angle glaucoma among Caucasians, despite treatment, may be significantly higher than previously considered.
Matthew G. Hattenhauer, MD, and colleagues at the Mayo Clinic conducted this retrospective, community-based descriptive study. Two-hundred ninety-five records of people diagnosed with and treated for open-angle glaucoma between 1965 and 1980 were examined.
The study authors estimate that at 20 years from diagnosis, the probability of blindness in at least one eye of those newly diagnosed and treated with medical or surgical therapy is 27%. The estimated incidence of blindness in both eyes is 9% at 20 years. These probability percentages also vary according to the class of glaucoma.
As an example, those with classic glaucoma have a 22% probability of blindness in both eyes and a 54% probability of blindness in at least one eye at 20 years. Those with treated ocular hypertension have an estimated probability of blindness in both eyes of 4% and in at least one eye of 14%.
This study shows that the risk of going blind from open-angle glaucoma, despite treatment, may be considerable in a Caucasian population in which severe or advanced cases would not be expected.