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To Our Valued Patients,

With the evolving situation of the Coronavirus (COVID-19) pandemic and under the guidelines of the Health Officer of the Alameda and Contra-Costa Counties, we will begin the process of re-opening our offices on Monday May 4th in order to provide needed eye and vision care. Moreover, cataract and all other non-cosmetic surgical procedures will soon resume.

Please keep in mind that in order to maintain social distancing protocols and to limit further transmission of the virus, we will be working with a reduced staff and seeing a fewer number of patients as compared to our “normal” schedule. Priority will be given to the most urgent medical cases. We will be implementing a number of measures (including altered check-in/check-out procedures, limiting the number of patients in the office and waiting room, face covering for all persons, temperature screening, etc) that will change your experience in the office. In addition, we will be ramping up our already strict disinfection policies and we will continue to monitor and abide by all local, state and, federal guidelines. Please bear with us through this new reality as these changes are designed to protect you and our staff.

We hope to see you soon and appreciate your trust in us to continue to meet your eye care needs. Stay safe and stay healthy!

The Turner Eye Institute Team

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HELP KERATOCONUS

NORTHERN CALIFORNIA & SAN FRANCISCO BAY AREA SPECIALISTS

HELP KERATOCONUS

NORTHERN CALIFORNIA & SAN FRANCISCO
BAY AREA SPECIALISTS

Home » What's New » Addition Technology Receives FDA Approval for Intacs for Keratoconus

Addition Technology Receives FDA Approval for Intacs for Keratoconus

Medical Device may restore visual function for patients with keratoconus and could defer the need for corneal transplant for moderate to severe keratoconus

DES PLAINES, Ill. Aug. 4, 2004 Addition Technology, Inc., the manufacturer of Intacs prescription inserts for surgical vision correction, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for a Humanitarian Device Exemption (HDE) to market Intacs inserts for the treatment of keratoconus. Keratoconus causes a progressive thinning of the cornea and affects up to 300,000 people in the United States.

The FDA approval is based on Intacs excellent safety record, the relatively low number of U.S. patients affected by keratoconus, and the fact that no other treatment options exist for patients with keratoconus other than an invasive corneal transplant procedure. The approval allows Intacs inserts to be marketed for the reduction or elimination of myopia and astigmatism in patients with keratoconus, where functional vision is no longer achievable with their contact lenses or eyeglasses. In addition, Intacs inserts may defer the need for a corneal transplant for some keratoconus patients.

The FDA approval will allow Addition Technology to educate keratoconus patients about the potential advantages of Intacs inserts and is expected to help facilitate expanded health insurance coverage for the procedure in the United States.

“Keratoconus sufferers now have a new option when it comes to restoring and improving their vision,” said William M. Flynn, president and chief executive officer of Addition Technology. “Intacs inserts fill a significant gap between rigid contact lenses and corneal transplantation for these patients.”

“For many of my patients, Intacs provide a solution to obtaining functional vision where contact lenses no longer suffice,” said Yaron Rabinowitz, M.D., of Cedars Sinai Medical Center in Los Angeles, Calif. “Before Intacs inserts, the only option was a corneal transplant, which I prefer to be a last resort for these patients.”

“In the past few years my condition caused my astigmatism to increase to the point where I couldn’t wear contact lenses comfortably and my best corrected spectacle correction was deteriorating each year. Even though the morbidity risk was low, I was reluctant to consider corneal transplantation, since the convalescent period was lengthy and as an ophthalmic surgeon, I needed good binocular vision to continue to operate,” said ophthalmologist Leslie A. Eisner, M.D. of Stamford, Conn. “Intacs in my right eye has improved and stabilized my vision, allowing me to resume my normal activities without undergoing a highly invasive transplant procedure. I can now wear soft toric contact lenses comfortably and with good vision. I’m so pleased with the results that I plan to have the left eye done this winter.”

Addition Technology, Inc., a privately held company, is the manufacturer of Intacs prescription inserts, the only corneal implant approved by the FDA. Intacs inserts are also approved for distribution in Europe, Asia, and Latin American countries that include Mexico. For more information on Intacs prescription inserts, visit www.helpkeratoconus.com or call 1.800.339.2733.