The AMO Tecnis Lens Implant Shows Potential for Improvement of Night
Vision following Cataract Surgery
4/20/04
AMO / Pfizer Inc.
announced today that the U.S. Food and Drug Administration (FDA)
has approved new labeling claims for the Tecnis Lens Implant. This
is the first lens implant (intraocular lens/IOLs) to receive
such claims for reduction of postoperative spherical aberrations and improved
night driving simulator performance.
Approximately 60 percent of adults over 65 have some degree of cataract
development, and cataract surgery is the most common operation in the U.S. Due to the expected doubling in the number of people over age 65 from 35
million in 2000 to 71 million in 2030, and because drivers over age 65 are
more likely to be involved in car crashes than people in their 30's, 40's and
50's; providing elderly cataract patients with improved visual capability
and driving safety represents a growing healthcare imperative
The Tecnis lens was specifically designed to improve the functional vision
of cataract surgery patients. Functional vision is the ability to see objects
in varying light conditions. In a clinical study, Tecnis demonstrated
improved functional vision. Improving the functional vision of elderly
drivers with the Tecnis lens in less than ideal conditions, such as nighttime,
rain, snow, fog and twilight may increase the safety of all drivers and
pedestrians on the road.
"The ability of the Tecnis lens to improve functional vision sets a new
standard in the treatment of cataract patients," said Mark Packer, MD,
Clinical Assistant Professor, Casey Eye Institute, Department of
Ophthalmology, Oregon Health & Science University, and Principal Investigator
for the Tecnis clinical study. "Many Tecnis patients see very well in low
light conditions and tell me they feel comfortable driving at night for the
first time in years."
Clinical Study Results:
A controlled, multi-center, intra-individual clinical investigation of the
Tecnis lens and a traditional acrylic lens (with a spherical optic) was
conducted.
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The results of the postoperative ocular spherical
aberration measurements and the night driving simulation results are both statistically and clinically significant in favor of the
Tecnis lens.
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Spherical aberrations (undesirable scattering of light which negatively
affects vision) were significantly less with the Tecnis lens than with the
traditional lens with the spherical optic.
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The simulated night driving
results (functional vision) under several of the conditions tested and the
visual acuity (i.e., 20/20, 20/40, etc.) results were statistically
significantly better in eyes implanted with the Tecnis lens (Tecnis eyes).
"Over the past five years, research about the eye has shown that the
cornea and the young lens in the eye interact to produce a very high quality
vision," said Jack Holladay, MD, MSEE, FACS, and Clinical Professor of
Ophthalmology at Baylor College of Medicine. "The ability of the Tecnis IOL
to mimic this interaction in the young eye is the most important advance in
the design of intraocular lenses in over two decades."
A subset of patients was randomly selected
from all investigational sites to participate in testing in a
validated night driving simulator. Patients were tested in four
nighttime conditions: normal city, city with glare, normal rural
and rural with glare. In each setting, patients were asked to
detect and identify targets including white-on-green information
highway signs, black-on-yellow warning signs and pedestrian
hazards. They were asked to respond when the sign or the hazard
was first detected, and the detection distances were recorded.
Patients were then asked to respond when the sign or hazard
could first be identified, i.e., what did the sign say, what
direction was the pedestrian walking, and the identification
distances were recorded. The Tecnis eyes performed functionally
better than the control eyes in 21 of the 24 conditions tested.
This means the Tecnis lens improves both detection and
identification distances across the driving scenes (city and
rural) and visibility conditions (with and without glare)
compared to the control lens. Tecnis eyes performed
statistically significantly better than the control eyes in nine
of the test conditions.
The Tecnis Lens Implant is being used by
Dr. D. Alan Chandler, MD
and Dr. Bryan Brooks of Richmond Eye Associates.
The Cataract / Implant Page
offers more information about cataracts and cataract surgery.
