6
Lens for 30 days. For the subjects that completed
the study, the average continuous wear time for
the PureVision
®
Contact Lens was 28.0 days per
month. The same subjects reported they were able
to wear the PureVision Contact Lens at least 22 days
continuously 94% of the times they were asked.
The contact lens visual acuity was measured at
each scheduled and unscheduled follow-up visit
throughout the one-year study. For the 610 subjects
that completed the study, visual acuity of 20/20 or
better was reported for 87% of the measurements for
the PureVision Contact Lens. Similarly, visual acuity of
20/25 or better was reported 98% of the time.
Post-aPProVal eXtended Wear study
The purpose of the post-approval study was to
investigate the occurrence of serious adverse events
with PureVision Contact Lenses when worn on a
30-day continuous wear basis. Serious adverse events
were any case of microbial keratitis (infected corneal
ulcer) or a loss of more than two lines of best corrected
visual acuity, that is the loss of the ability to read two
sizes of letters on the eye chart when corrected with
glasses, if needed.
The study analyzed the results of 6,412 patients that
accounted for 5,054 patient-years of compliant lens
wear. The incidence of microbial keratitis associated
with 30 days of continuous wear of PureVision
Contact Lenses was 13.9 cases per 10,000 patient-
years of lens wear. A statistical analysis of the data
based on 95% confidence determined this rate could
range between 3 and 25 cases per 10,000 patient-
years of lens wear. None of the subjects presenting
with microbial keratitis experienced a permanent
decrease of visual acuity of more than two lines.
Personal Cleanliness
and lens Handling
1. PreParing tHe lens for Wearing
It is essential that you learn and use good hygienic
methods in the care and handling of your new lenses.
Cleanliness is the first and most important aspect of
proper contact lens care. In particular, your hands
should be clean and free of any foreign substances
when you handle your lenses. The procedures are:
• Always wash your hands thoroughly with a mild
soap, rinse completely, and dry with a lint-free towel
before touching your lenses.
• Avoid the use of soaps containing cold cream,
lotion, or oily cosmetics before handling your
lenses, since these substances may come into
contact with the lenses and interfere with successful
wearing.
• Handle your lenses with your fingertips, and be
careful to avoid contact with fingernails. It is helpful
to keep your fingernails short and smooth.
Start off correctly by getting into the habit of always
using proper hygienic procedures so that they
become automatic.
2. Handling tHe lenses
•
Develop the habit of always working with the same
lens first to avoid mixups.
• Remove the lens from its storage case and examine
it to be sure that it is moist, clean, clear, and free of
any nicks or tears.
• Should you accidentally place an inside-out lens on
your eye, one of the following signs should signal
you to remove and replace it correctly.
a. Less than usual comfort
b. The lens may fold on the eye
c. Excessive lens movement on blink
d. Blurred vision
• If the lens folds and sticks together: Place the lens in
the palm of your hand and wet thoroughly with the
recommended rinsing or storing solution. (Refer
to the Lens Care Product Chart for the solutions
available from Lomb.) Then GENTLY rub
the lens between your index finger and palm in a
gentle back and forth motion.
• If this gentle rubbing does not work, soak the lens
in the recommended solution in your lens case until
the lens has resumed its normal shape. If the lens
flattens or drapes across your finger, the lens or
your finger may be too wet. To correct this, dry your
finger by transferring the lens several times from
one index finger to the other, drying the opposite
finger each time.
• Keep the lens wet in the solution recommended by
your eye care professional.
• Never place a lens on the eye unless it has been
fully hydrated (wet) with the recommended rinsing
or storing solution. (Refer to the Lens Care Product
Chart for the solutions available from
Lomb.)
3. PlaCing tHe lens on tHe eye
There are several methods of lens placement. If the
following methods are difficult for you, your eye care
professional will provide you with an alternate method.
Note: If after placement of the lens, your vision is blurred, check for the
following:
•
The lens is not centered on the eye (see “Centering
the Lens,” next in this booklet).
• If the lens is centered, remove the lens (see
“Removing the Lens” section) and check for the
following:
a. Cosmetics or oils on the lens. Clean, rinse,
disinfect, and place on the eye again.
b. The lens is on the wrong eye.
c. The lens is inside-out (it would also not be as
comfortable as normal).
If you find that your vision is still blurred after checking
the above possibilities, remove both lenses and consult
your eye care professional.
