Bausch & Lomb PureVision Toric Contact Lenses - Manual

Efficacy Outcomes
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% and 86% of the measurements for the PureVision Contact
Lens and Control lens, respectively. Similarly, visual acuity of 20/25 or better was reported 98%
and 97% of the times for the PureVision Contact Lens and Control lens.
Wearing Time
In this U.S. clinical study subjects were required to maintain a minimum wearing time in order
to continue in the study. For the subjects that completed the study, the average continuous wear
time for the PureVision Contact Lens was at least 28.0 days per month, from the 2-Month visit
through the 12-Month visit. At these visits 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.
During the course of the study, 15 subjects were discontinued from the study because they
were not able to wear the PureVision Contact Lens for 30 days. Twenty-one (21) subjects were
discontinued from the study because they were not able to wear the Control lens for 7 days.
Overnight Corneal Swelling
A study was conducted to assess the corneal swelling response induced by overnight contact
lens wear. Twenty-four (24) subjects each wore either a -3.00 –0.75 x 180º PureVision Toric
Contact Lens (Test Lens) or a -3.00D PureVision Contact Lens (Control lens) on the contralateral
eye overnight under closed eye conditions for approximately eight hours. The corneal swelling,
measured as the percent increase in the center thickness of the cornea, of the eyes wearing a
PureVision Toric Lens (4.1%) was compared to the swelling response to the Control lens (3.6 %).
The responses were not statistically different (p-value > 0.20).
SELECTION OF PATIENTS
The eye care professional should not fit patients who cannot or will not adhere to a
recommended care or replacement regimen, or are unable to place and remove the lenses
should not be provided with them. Failure to follow handling and cleaning instructions could lead
to serious eye infections which might result in corneal ulcers.
Patient communication is vital because it relates not only to patient selection but also to ensure
compliance. It is also necessary to discuss the information contained in the Patient Information
Booklet with the patient at the time of the initial examination.
Patients selected to wear Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lenses
should be chosen for their motivation to wear contact lenses, general health and cooperation.
The eye care professional must take care in selecting, examining and instructing contact lens
patients. Patient hygiene and willingness to follow practitioner instructions are essential to
their success.
A detailed history is crucial to determining patient needs and expectations. Your patient should
be questioned regarding vocation, desired lens wearing time (full or part time), and desired lens
usage (reading, recreation or hobbies).
Initial evaluation of the trial lens should be preceded by a complete eye examination, including
visual acuity with and without correction at both distance and near, keratometry and slit lamp
examination.
It is normal for the patient to experience mild symptoms such as lens awareness, variable vision,
occasional tearing (watery eyes) and slight redness during the adaptation period. Although the
adaptation period varies for each individual, generally within one week these symptoms will
disappear. If these symptoms persist, the patient should be instructed to contact his or her eye
care professional.
FITTING PROCEDURE
1. Pre-Fitting Examination
A pre-fitting patient history and examination are necessary to:
• Determine whether a patient is a suitable candidate for daily wear contact lenses
(consider patient hygiene and mental and physical state),
• Make ocular measurements for initial contact lens parameter selection,
and
• Collect and record baseline clinical information to which post-fitting examination results
can be compared.
A prefitting examination should include spherocylinder refraction and VA, keratometry, and
biomicroscopic examination.
2. Initial Lens Power Selection Selection
a. Select the initial trial lens from the Toric Diagnostic Lens Set with a power most similar
to the patients refractive needs, or order a diagnostic lens to the prescription which most
closely matches that of the patient.
b. Place the lens on the eye and allow the lens to remain on the eye long enough (10
to 20 minutes) to achieve a state of equilibrium. Small variations in the tonicity, pH of
the lens solutions, and individual tear composition may cause slight changes in fitting
characteristics.
c. Allow any increase in tear flow to subside before evaluating the lens. The time required
will vary with the individual.
3. Initial Lens Evaluation
a. To determine proper lens parameters, observe the lens relationship to the eye using
a slit lamp. The toric diagnostic lens is used to optimize lens fitting characteristics and
determine axis orientation. Lens power is determined by the spectacle refraction.
• Rotation evaluation: The center guide mark should locate at the inferior limbus. The
additional guide marks at 30° on either side can be used as reference points, and to
help the professional assess axis orientation and stability. Once oriented, rotational
rocking should be limited to less than 5°.
• Movement: The lens should provide discernible movement with:
– Primary gaze blink
– Upgaze blink
– Upgaze lag
• Centration: The lens should provide full corneal coverage.
b. Determine contact lens power. When the toric diagnostic lens does not have a power
equivalent to their spectacle Rx, sphero-cylinder over-refractions will often be inaccurate
and confusing. Therefore it is usually preferable to use the spectacle Rx as the only basis
for the contact lens power. The sphere and cylinder power of the spectacle Rx becomes
the sphere and cylinder power of the contact lens. There are two exceptions:
1. If spectacle cylinder power falls between available contact lens cylinder powers,
prescribe the lesser contact lens cylinder power. The sphere power can be increased
-0.25D to compensate if desired. Of course, this can vary depending on your
interpretation of the patient’s subjective responses.
Example:
Spectacle Rx -2.00 -1.00 X 180
Contact Lens Power Ordered -2.25 -0.75 X 180
2. When the spectacle lens power in any principle meridian is greater than 4.00D, the
spectacle refraction should be vertexed to the corneal plane. This can affect both the
sphere and cylinder powers ordered.
Example:
Spectacle Rx -5.00 -2.75 X 180
Contact Lens Power Ordered -4.75 -2.25 X 180
c. Determine contact lens axis. Note the orientation of the guide marks relative to the
vertical meridian. Regardless of which eye the lens is on , if the rotation is clockwise but
stable, note the amount of rotation, add it to the refractive cylinder axis and order the
resulting axis. If the rotation has stabilized counter-clockwise, again note the rotation,
subtract it from the refractive axis and order the resulting axis. The guide marks can be
used to help you calculate the axis of the desired Rx lens.
For Example:
Spectacle Rx -2.50 -1.25 X 80
Rotation 20° clockwise
Final Lens Prescription: -2.50 -1.25 X 100
d. Select patient’s lenses.
e. Evaluate orientation of final Rx lenses. The orientation of the prescription should be
the same as that observed for the Fitting Set Lenses. For example, if the lens rotated
clockwise 15° then the final prescription lens should also rotate clockwise 15°.
4. Criteria of a Well-Fitted Lens
If the initial lens selection fully covers the cornea, provides discernible movement after a
blink, is comfortable for the patient and provides satisfactory visual performance, it is a well
fitted lens and can be dispensed.
5. Characteristics of a Tight (Steep) Lens
A lens which is much too steep may subjectively and objectively cause distortion which
will vary after a blink. However, if a lens is only marginally steep, the initial subjective and
objective vision and comfort findings may be quite good. A marginally steep lens may be
differentiated from a properly fitted lens by having the patient gaze upward. A properly
fitted lens will tend to slide downward approximately 0.5mm while a steep lens will remain
relatively stable in relationship to the cornea, particularly with the blink.
With your finger, gently rotate the lens approximately 45° to the temporal side. It should
reorient within 5 to 10 blinks back to the same stabilized position.
6. Characteristics of a Loose (Flat) Lens
If the lens is too flat, it will:
– Decenter, especially on post-blink.
– Have a tendency to edge lift inferiorly and sit on the lower lid, rather than positioning
between the sclera and palpebral conjunctiva.
– Have a tendency to be uncomfortable and irritating with fluctuating vision.
– Have a tendency to drop or lag greater than 2.0mm on upgaze post-blink.
7. Follow-up Care
a. Follow-up examinations are necessary to ensure continued successful contact lens wear.
From the day of dispensing, the following schedule is a suggested guideline for follow up.
• 24 hours
• 10 days
• 1 month
• 3 months
• every six months thereafter
At the initial follow-up evaluations the eye care professional should again reassure the
patient that any of the previously described adaptive symptoms are normal, and that the
adaptation period should be relatively brief. Depending on the patients prior experience
with contact lenses and/or continuous wear, the eye care professional may consider
prescribing a one week period of daily wear adaption prior to beginning continuous wear.
b. Prior to a follow-up examination, the contact lenses should be worn for at least 4
continuous hours and the patient should be asked to identify any problems which
might be occurring related to contact lens wear. If the patient is wearing the lenses for
continuous wear, the follow-up examination should be conducted as early as possible the
morning after overnight wear.
c. With lenses in place on the eyes, evaluate fitting performance to assure that CRITERIA
OF A WELL FITTED LENS continue to be satisfied. Examine the lenses closely for surface
deposition and/or damage.
d. After the lens removal, instill sodium fluorescein [unless contraindicated] into the eyes
and conduct a thorough biomicroscopy examination.
1. The presence of vertical corneal striae in the posterior central cornea and/or corneal
neovascularization may be indicative of excessive corneal edema.
2. The presence of corneal staining and/or limbal-conjunctival hyperemia can be
indicative of an unclean lens, a reaction to solution preservatives, excessive lens
wear, and/or a poorly fitting lens.
3. Papillary conjunctival changes may be indicative of an unclean and/or damaged lens.
If any of the above observations are judged abnormal, various professional judgments are
necessary to alleviate the problem and restore the eye to optimal conditions. If the CRITERIA
OF A WELL FITTED LENS are not satisfied during any follow-up examination, the patient should
be re-fitted with a more appropriate lens.
PRACTITIONER FITTING SETS
Lenses must be discarded after each use and must not be used from patient to patient.
WEARING SCHEDULE
The wearing and replacement schedules should be determined by the eye care professional.
Regular checkups, as determined by the eye care professional, are extremely important.
Daily Wear
There may be a tendency for the daily wear patient to over wear the lenses initially. Therefore,
the importance of adhering to a proper, initial daily wearing schedule should be stressed to these
patients. The wearing schedule should be determined by the eye care professional. The wearing
schedule chosen by the eye care professional should be provided to the patient.
Continuous Wear (Greater than 24 hours or while asleep)
The wearing schedule should be determined by the prescribing eye care professional for each
individual patient, based upon a full examination and patient history as well as the practitioner’s
experience and professional judgment. Bausch & Lomb recommends beginning continuous
wear patients with the recommended initial daily wear schedule, followed by a period of daily
wear, and then gradual introduction of continuous wear one night at a time, unless individual
considerations indicate otherwise.
The practitioner should examine the patient in the early stages of continuous wear to determine
the corneal response. The lens must be removed, cleaned and disinfected or disposed of and
replaced with a new lens, as determined by the prescribing eye care professional. (See the
factors discussed in the Warnings section.) Once removed, a lens should remain out of the
eye for a period of rest overnight or longer, as determined by the prescribing eye care
professional.
MONOVISION FITTING GUIDELINES
1. Patient Selection
a. Monovision Needs Assessment
For a good prognosis the patient should have adequately corrected distance and
near visual acuity in each eye. The amblyopic patient or the patient with significant
astigmatism (greater than one [1] diopter) in one eye may not be a good candidate
for monovision with the Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted
Contact Lenses.
Occupational and environmental visual demands should be considered. If the patient
requires critical vision (visual acuity and stereopsis) it should be determined by trial
whether this patient can function adequately with monovision.
Monovision contact lens wear may not be optimal for such activities as:
(1) visually demanding situations such as operating potentially dangerous
machinery or performing other potentially hazardous activities;
and
(2) driving automobiles (e.g., driving at night). Patients who cannot pass their state
drivers license requirements with monovision correction should be advised to
not drive with this correction, OR may require that additional over-correction be
prescribed.
b. Patient Education
All patients do not function equally well with monovision correction. Patients may not
perform as well for certain tasks with this correction as they have with bifocal reading
glasses. Each patient should understand that monovision can create a vision compromise
that may reduce visual acuity and depth perception for distance and near tasks. During
the fitting process it is necessary for the patient to realize the disadvantages as well as
the advantages of clear near vision in straight ahead and upward gaze that monovision
contact lenses provide.
2. Eye Selection
a. Ocular Preference Determination Methods
Generally, the non-dominant eye is corrected for near vision. The following test for eye
dominance can be used.
Method 1—Determine which eye is the “sighting dominant eye.” Have the patient point
to an object at the far end of the room. Cover one eye. If the patient is still pointing
directly at the object, the eye being used is the dominant (sighting) eye.
Method 2—Determine which eye will accept the added power with the least reduction in
vision. Place a trial spectacle near add lens in front of one eye and then the other while
the distance refractive error correction is in place for both eyes. Determine whether the
patient functions best with the near add lens over the right or left eye.
b. Refractive Error Method
For anisometropic corrections, it is generally best to fit the more hyperopic (less myopic)
eye for distance and the more myopic (less hyperopic) eye for near.
c. Visual Demands Method
Consider the patient’s occupation during the eye selection process to determine the
critical vision requirements. If a patient’s gaze for near tasks is usually in one direction
correct the eye on that side for near.
Example:
A secretary who places copy to the left side of the desk will usually function best with
the near lens on the left eye.
3. Special Fitting Considerations
Unilateral Lens Correction
There are circumstances where only one contact lens is required. As an example, an
emmetropic patient would only require a near lens while a bilateral myope may require only
a distance lens.
Example:
A presbyopic emmetropic patient who requires a +1.75 diopter add would have a +1.75 lens
on the near eye and the other eye left without a lens.
A presbyopic patient requiring a +1.50 diopter add who is -2.50 diopters myopic in the right
eye and -1.50 diopters myopic in the left eye may have the right eye corrected for distance
and the left uncorrected for near.
4. Near Add Determination
Always prescribe the lens power for the near eye that provides optimal near acuity at the
midpoint of the patient’s habitual reading distance. However, when more than one power
provides optimal reading performance, prescribe the least plus (most minus) of the powers.
5. Trial Lens Fitting
A trial fitting is performed in the office to allow the patient to experience monovision
correction. Lenses are fit according to the directions in the general fitting guidelines.
Case history and standard clinical evaluation procedure should be used to determine the
prognosis. Determine which eye is to be corrected for distance and which eye is to be
corrected for near. Next determine the near add. With trial lenses of the proper power in
place observe the reaction to this mode of correction.
Immediately after the correct power lenses are in place, walk across the room and have the
patient look at you. Assess the patient’s reaction to distance vision under these circumstances.
Then have the patient look at familiar near objects such as a watch face or fingernails. Again
assess the reaction. As the patient continues to look around room at both near and distance
objects, observe the reactions. Only after these vision tasks are completed should the patient
be asked to read print. Evaluate the patient’s reaction to large print (e.g. typewritten copy) at
first and than graduate to news print and finally smaller type sizes.
After the patient’s performance under the above conditions are completed, tests of visual
acuity and reading ability under conditions of moderately dim illumination should be
attempted.
An initial unfavorable response in the office, while indicative of a guarded prognosis, should
not immediately rule out a more extensive trial under the usual conditions in which a patient
functions.
6. Adaptation
Visually demanding situations should be avoided during the initial wearing period. A patient
may at first experience some mild blurred vision, dizziness, headaches, and a feeling of slight
imbalance. You should explain the adaptational symptoms to the patient. These symptoms
may last for a brief minute or for several weeks. The longer these symptoms persist, the
poorer the prognosis for successful adaptation.
To help in the adaptation process the patient can be advised to first use the lenses in a
comfortable familiar environment such as in the home.
Some patients feel that automobile driving performance may not be optimal during the
adaptation process. This is particularly true when driving at night. Before driving a motor
vehicle, it may be recommended that the patient be a passenger first to make sure that
their vision is satisfactory for operating an automobile. During the first several weeks of
wear (when adaptation is occurring), it may be advisable for the patient to only drive during
optimal driving conditions. After adaptation and success with these activities, the patient
should be able to drive under other conditions with caution.
7. Other Suggestions
The success of the monovision technique may be further improved by having your patient
follow the suggestions below.
– Having a third contact lens (distance power) to use when critical distance viewing is
needed.
– Having a third contact lens (near power) to use when critical near viewing is needed.
– Having supplemental spectacles to wear over the monovision contact lenses for specific
visual tasks may improve the success of monovision correction. This is particularly
applicable for those patients who cannot meet state licensing requirements with a
monovision correction.
– Make use of proper illumination when carrying out visual tasks.
Success in fitting monovision can be improved by the following suggestions.
– Reverse the distance and near eyes if a patient is having trouble adapting.
– Refine the lens powers if there is trouble with adaptation. Accurate lens power is critical
for presbyopic patients.
– Emphasize the benefits of the clear near vision in straight ahead and upward gaze with
monovision.
* The decision to fit a patient with a monovision correction is most appropriately left to
the eye care professional in conjunction with the patient after carefully considering the
patient’s needs.
* All patients should be supplied with a copy of the Bausch & Lomb PureVision Toric
(balafilcon A) Visibility Tinted Contact Lens Patient Information Booklet.
HANDLING OF LENSES
Patient Lens Care Directions
When lenses are dispensed, the patient should be provided with appropriate and adequate
instructions and warnings for lens care handling. The eye care professional should recommend
appropriate and adequate procedures and products for each individual patient in accordance with
the particular lens wearing schedule and care system selected by the practitioner, the specific
instructions for such products and the particular characteristics of the patient.
Frequent/Planned Replacement
For complete information concerning the care, cleaning and disinfection of contact lenses
refer to the Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens Patient
Information Booklet.
Disposable Wear
For complete information concerning emergency lens care, refer to the Bausch & Lomb
PureVision Toric (balafilcon A) Visibility Tinted Contact Lens Patient Information Booklet.
CARE FOR A STICKING (NONMOVING) LENS
If the lens sticks (stops moving), the patient should be instructed to use a lubricating or
rewetting solution in their eye. The patient should be instructed to not use plain water, or
anything other than the recommended solutions. The patient should be instructed to contact the
eye care professional if the lens does not begin to move upon blinking after several applications
of the solution, and to not attempt to remove the lens except on the advice of the eye care
professional.
REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in patients wearing Bausch &
Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lenses or experienced with the
lenses should be reported to:
Bausch & Lomb Incorporated
Rochester, New York 14609
Toll Free Telephone Number
In the Continental U.S., Alaska, Hawaii
1-800-828-9030
In New York State
1-800-462-1720
In Canada
1-800-459-5000
HOW SUPPLIED
Each sterile lens is supplied in a plastic package containing borate buffered saline solution. The
container is marked with the manufacturing lot number of the lens, the base curve, sphere
power, cylinder power, axis, diameter and expiration date. Store lenses at room temperature
(60°F to 80°F / 15°C to 25°C).
Bausch & Lomb Incorporated
Rochester, NY 14609
© Bausch & Lomb Incorporated. All rights reserved worldwide.
Bausch & Lomb, Performa, AerGel, Lo-Torque and PureVision are trademarks of Bausch & Lomb
Incorporated. Other brand names/product names are trademarks of their respective owners.
Printed in U.S.A.
8040002
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Visibility Tinted
Contact Lenses
PACKAGE INSERT/
FITTING GUIDE
CAUTION: Federal (U.S.A.) law restricts this device to sale by
or on the order of a licensed practitioner.
SYMBOL REFERENCE GUIDE
For label and cartons:
Quality System Certification Symbol
Fee Paid for Waste Management
Sterile Using Steam or Dry Heat
See Instruction Leaflet
Diameter
Use by Date (Expiration Date)
Batch Code
Authorized Representative in European Community
Caution: Federal (U.S.A.) law restricts this device to
sale by or on the order of a licensed practitioner
Base Curve
Sphere Power (Diopters)
Cylinder Axis (Degrees)
Cylinder Power (Dipoters)
Storage Temperature