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Important Safety Information
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Hydrogen Peroxide Lens Care Hits Two-Year Share High in U.S.
According to data from CIBA Vision, in the third quarter of 2007 the hydrogen peroxide lens care product category accounted for 14 percent of the total disinfectant category retail sales, the highest share it has achieved in the United States since the fourth quarter of 2005. These results may reflect a change in eye care professional recommendations of lens care products.
Global Keratoconus Congress 2007
Register now for the second Global Keratoconus Congress to be held January 25-27, 2008 in Las Vegas. This meeting will be hosted at Bally's on the Las Vegas Strip. Please visit http://www.GKCongress.com. There you will find the most up-to-date educational program agenda and information on hotel accommodations, as well as the ability to register for the event.
Companies interested in exhibiting should contact Heather Seasholtz at 215-643-8073.
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Abstract: Optical and Surgical Correction of Keratoconus
Researchers in the United Kingdom set out to investigate and correlate optical correction, and progression to penetrating keratoplasty (PKP), with the corneal, refractive, topographic and familial characteristics of subjects with keratoconus within the Tayside region of Scotland. This was a prospective, observational, longitudinal study design. Two hundred subjects with keratoconus were enrolled into the Dundee University Scottish Keratoconus Study (DUSKS) and were assessed during a 4-year period using standardized clinical assessment, computerized corneal topography and questionnaires.
Keratoconic subjects in this study wore rigid contact lenses (90.6%) for longer than 12 hours per day (81%), 7 days a week (91%) and achieved a very good level of Snellen visual acuity (97%, >/=6/9). Corneal staining was observed in the majority of corneas (71%), although only a small percentage of subjects reported major problems of: discomfort (18%), hyperaemia (16%), or the lens falling out (4%). Poor visual acuity was the main reason (79%) for undergoing PKP usually in the latter part of the third decade of life, approximately a decade after diagnosis. During the study period 4% of eyes progressed to PKP. Only a small percentage of eyes (9.5%) required no visual correction postoperatively.
Per the authors’ conclusions, the main mode of visual rehabilitation for keratoconus was rigid contact lenses, which were mostly worn successfully with good visual acuity. During the study period a small minority of keratoconics progressed to corneal graft surgery. It is advisable to emphasize that postoperative refractive correction will be required in the majority of these cases.
Weed KH, Macewen CJ, McGhee CN. The Dundee University Scottish Keratoconus Study II: a prospective study of optical and surgical correction. Ophthalmic Physiol Opt. 2007 Nov;27(6):561-7
Editor's Commentary: Off-Label Use
Recent FDA approvals of Iquix for stand-alone therapy of corneal ulcers and Acuvue Oasys for therapeutic bandage lens use, coupled with a patient I recently examined who was wearing an O2Optix Custom lens for aphakia on an extended wear basis, had me thinking about "off-label use" of both therapeutics and medical devices. When I say "off-label use" I mean that the medication or contact lens is not FDA approved for how you are prescribing it. In the example of the O2Optix Custom patient, this lens does not have extended wear approval so the treatment is an off-label use of this device. However, for this patient who is reliant on his wife (who was also visually disabled) for application, removal and care of the contact lens, some overnight wear was the best option. This patient and his wife both received extensive verbal discussion that there are other alternative options (no lens, daily wear of this lens, GP or EW GP options) and risks with using this lens for its intended purpose and the off-label use as extended wear. This discussion was then carefully documented in the medical record. When prescribing any medication or contact lens "off-label", always inform the patient why you feel this is the best therapy, what the expected outcomes with and without this treatment are, what the risks are and what the other alternatives to this treatment are. All of your verbal discussions and recommendations must be documented in detail in the medical record.
Carla Mack, O.D., F.A.A.O.
This month at http://www.siliconehydrogels.org explore the significance of the recent “no-rub” solution recalls, learn about atypical upper lid margin staining in dry-eyed silicone hydrogel wearers and review the latest in silicone hydrogel research.
Report adverse contact lens reactions here: http://www.accessdata.fda.gov/scripts/medwatch/ or call (800) FDA-1088.
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