User Manual

Summary of Slit Lamp Findings
Slit lamp examinations were conducted at every study visit. Each graded slit lamp
parameter was scored on a qualitative grade scale ranging from 0 to 4, with Grade 0
representing the absence of findings, and Grades 1 through 4 representing successively
worse findings. For each study eye, a determination was made for each parameter
as to whether, or not a positive finding was presented at any visit. The following table
describes slit lamp findings ≥
Grade 2 and ungraded slit lamp findings.
PureVision Control
Graded Slit Lamp Findings ( ≥ Grade2 )
Any Finding
1,2
17.5% 17.6%
Corneal Staining 8.2% 8.4%
Limbal Injection 3.7% 4.3%
Bulbar Injection 5.2% 4.7%
Tarsal Conjunctival Abnormalities 3.9% 3.9%
Corneal Infiltrates
1
2.9% 1.3%
Epithelial Edema 1.3% 1.4%
Epithelial Microcysts 1.0% 1.0%
Corneal Neovascularization 1.0% 1.7%
Ungraded Slit Lamp Findings
Other Anterior Segment Abnormalities
3
13.2% 13.8%
External Adnexa Abnormalities 2.7% 2.7%
Conjunctivitis 2.4% 2.0%
Corneal Striae 0.0% 0.3%
1
Slit Lamp Finding and Corneal Infiltrates ≥ Grade 2 were the safety endpoints for this study.
2
The total of all Graded slit lamp findings does not equal the category of Any Finding.
3
The more common findings identified as Other Anterior Segment Abnormalities included
conjunctival staining; dimple veils; mucin balls; lipid deposits; and ghost vessels.
It should be noted that the PureVision
®
Contact Lens and the Control lens were each fit
on only the right or left eye for each subject. Rates per subject are expected to be higher
when lenses are fit on both eyes.
Corneal Infiltrates
The following table describes the rate of corneal infiltrates according to the lens power
used.
PureVision
Lens Power
Corneal Infiltrates
(≥ Grade 2)
Plano to – 3.00 1.7 %
– 3.25 to – 6.00 3.2 %
> – 6.00 6.4 %
Total 2.9 %
Control
Lens Power
Corneal Infiltrates
(≥ Grade 2)
Plano to – 3.00 0.9 %
– 3.25 to – 6.00 1.5 %
> – 6.00 1.3 %
Total 1.3 %
Other Lens-Related Adverse Events
In addition to the outcomes described above, the following lens related adverse
events were noted. This table does not include conjunctivitis or tarsal conjunctival
abnormalities, e.g., giant papillary conjunctivitis.
Other Important Lens-Related Adverse Events
PureVision Control
Corneal Scar 14 (1.8 %) 5 (0.6 %)
Other Ocular Inflammation* 10 (1.3 %) 2 (0.3 %)
Anterior Chamber Reaction 2 (0.3 %) 1 (0.1 %)
Permanent Loss of Vision 0 (0.0 %) 0 (0.0 %)
*
Other Ocular Inflammation includes episcleritis, scleritis, iritis/uveitis. This condition was reported
in association with other conditions such as keratitis, corneal infiltrates, blepharitis, corneal abrasion,
and contact lens over wear.
It should be noted that the PureVision
®
Contact Lens and Control lenses were each fit
on only the right or left eye for each subject. Rates per subject are expected to be higher
when lenses are fit on both eyes.
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
Two separate studies with the PureVision
®
Lens (spherical) assessed the corneal
swelling response induced by overnight contact lens wear. In the first study, 30 subjects
each wore either a +3.00D, -3.00D, or -9.00D PureVision Contact Lens and an
equivalent power lens made from a conventional hydrogel material (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, with the Control lens (9.1%) was significantly greater than that measured in
conjunction with the PureVision Contact Lenses (4.1%). In the second study, the corneal
swelling response was measured under similar conditions. In this study, the response to a
-3.00D PureVision Contact Lens (3.0%) was compared to the swelling response to no
lens wear (1.9%). The responses were not statistically different (p-value > 0.05).
SELECTION OF PATIENTS
The eye care professional should not fit, or provide lenses to, patients who cannot, or will
not, adhere to a recommended care or replacement regimen, or are unable to place
and remove the lenses. 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
®
2 Multi-Focal (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 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 pre-fitting examination should include spherocylinder refraction and VA, keratometry,
and biomicroscopic examination.
2. Initial Lens Power Selection
a. Perform a preliminary evaluation to determine distance refraction and near add
requirements.
b. Determine patient’s spherical equivalent refractive error corrected to the corneal
plane.
c. For each eye, select a lens of the power closest to the patient’s spherical equivalent
distance Rx.
d. Select the appropriate ADD.
• Bausch + Lomb
PureVision
®
2 Multi-Focal Low Add.
• Bausch + Lomb
PureVision
®
2 Multi-Focal High Add.
e. Measure binocular near and distance VA.
f. Make adjustments in power as necessary. The use of hand held trial lenses will
simplify fitting and minimize lens changes. To improve near vision, add plus in +0.25D
increments to both eyes. If distance vision becomes unacceptable with this change, add
plus to the non-dominant eye only. Measure near, then distance VA binocularly then
monocularly. To improve distance vision, add minus in –0.25 increments in both eyes.
If near vision becomes unacceptable with this change, add minus to the dominant eye
only. Measure distance, then near VA, binocularly then monocularly.
g. Make final lens changes and confirm acuity. Attempt to minimize any resultant
binocular imbalance.
Demonstrate vision:
a. under normal conditions
b. at near in any position of gaze
c. in decreased illumination
d. at intermediate distances
3. Initial Lens Evaluation
a. To determine proper lens parameters observe the lens relationship to the eye using a
slit lamp.
• Movement: The lens should provide discernible movement with:
– Primary gaze blink
– Upgaze blink
– Upgaze lag
• Centration: The lens should provide full corneal coverage.
b. Lens evaluation allows the contact lens fitter to evaluate the lens/cornea relationship
in the same manner as would be done with any soft lens. If after the lens has settled
on the eye, the patient reports lens sensation, or if the lens is moving or decentering
excessively, the lens should not be dispensed. Alternatively, if the patient reports
variable vision, or if the lens shows insufficient movement, the lens should not be
dispensed.
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.
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 patient’s prior
experience with contact lenses and/or continuous wear, the eye care professional may
consider prescribing a one week period of daily wear adaptation 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 a single 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.
MULTI-FOCAL FITTING GUIDELINES
1. Patient Selection
a. Good motivation
b. Realistic expectations
2. Lens Selection
a. Select the patient’s distance spectacle sphere (must be in mins cylinder form, ignore the
cylinder) and vertex, if necessary.
b. Select the appropriate ADD.
• Bausch + Lomb
PureVision
®
2 Multi-Focal Low Add.
• Bausch + Lomb
PureVision
®
2 Multi-Focal High Add.
3. Lens Fitting
a. Equilibrate for 10 minutes.
b. Lens should center well with 0.5 – 1.0mm movement in primary gaze, 1.0 – 1.5mm
upward gaze.
c. Check distance acuity monocularly in normal room illumination.
d. Over-refract if necessary in 0.25D steps to 20/25.
e. Check distance acuity binocularly. Over-refract if necessary in 0.25D steps to 20/20.
f. Check near acuity binocularly, with distance over-refraction still in place.
4. Symptom Resolution
a. Acuity – 0.25D makes a significant difference in acuity, re-check near and distance
acuities with over-refraction in place.
b. Distance visual acuity not acceptable –
If patient is wearing two Low ADD lenses:
1. Add –0.25D to the dominant eye.
If patient is wearing two High ADD lenses:
1. Add –0.25D to the dominant eye.
2. Use a Low ADD in the dominant eye and a High ADD in the non-dominant eye.
c. Near visual acuity not acceptable –
If patient is wearing two Low ADD lenses:
1. Add +0.25D to the non-dominant eye
2. Use a Low ADD in dominant eye and High ADD in non-dominant eye
3. If near vision is still not acceptable, use High ADD in both eyes
If patient is wearing two High ADD lenses:
1. Add +0.25D to non-dominant eye.
5. Patient Education
All patients do not function equally well with multifocal correction. Patients may not
perform as well for certain tasks with this correction as they have with multifocal
reading glasses. Each patient should understand that multifocal correction 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 multifocal contact lenses provide.
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
®
2 Multi-Focal (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 multifocal
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 the
room at both near and distant 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 then graduate to newsprint 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
®
2
Multi-Focal (balafilcon A) Visibility Tinted Contact Lens Patient Information
Booklet.
HANDLING OF LENS
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 professional, the specific instructions for such products and the
particular characteristics of the patient.
Frequent / Planned Replacement Wear: For complete information concerning
the care, cleaning and disinfection of contact lenses refer to the Bausch + Lomb
PureVision
®
2 Multi-Focal (balafilcon A) Visibility Tinted Contact Lens Patient
Information Booklet.
Disposable Wear: For complete information concerning emergency lens care, refer
to the Bausch + Lomb PureVision
®
2 Multi-Focal (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.
CARE FOR A DRIED OUT
(DEHYDRATED) LENS
If a soft, hydrophilic contact lens is exposed to air while off the eye, it may become dry
and brittle and need to be rehydrated. If the lens is adhering to a surface, apply the
recommended rinsing solution before handling.
To rehydrate the lens:
- Handle the lens carefully.
- Place the lens in its storage case and soak the lens in a recommended rinsing and
storing solution for at least 1 hour until it returns to a soft state.
- Clean lens first, then disinfect the rehydrated lens using a recommended lens care
system.
- If after soaking, the lens does not become soft, if the surface remains dry, DO NOT
USE THE LENS UNTIL IT HAS BEEN EXAMINED BY YOUR EYE CARE
PROFESSIONAL.
EMERGENCIES
If chemicals of any kind (household products, gardening solutions, laboratory chemicals,
etc.) are splashed into your eyes, you should: FLUSH EYES IMMEDIATELY WITH
TAP WATER AND THEN REMOVE LENSES PROMPTLY. CONTACT YOUR
EYE CARE PROFESSIONAL OR VISIT A HOSPITAL EMERGENCY ROOM
WITHOUT DELAY.
REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in patients wearing
Bausch + Lomb PureVision
®
2 Multi-Focal (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
1-800-553-5340
In Canada
1-888-459-5000 (Option 1 - English, Option 2 - French)
HOW SUPPLIED
Each sterile lens is supplied in a plastic blister package containing borate buffered saline
solution. The container is marked with the manufacturing lot number of the lens, the
base curve, sphere power, add power, diameter and expiration date.
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