Multi-Focal
Multi-Focal
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.
IMPORTANT:
This package insert and fitting guide has been developed to provide practitioners with information covering characteristics of the BAUSCH & LOMB®
PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lens and to illustrate fitting procedures. It is effective as of October 2005 and supersedes all
prior fitting guides for the product described. Please read carefully and keep
this information for future use.
This package insert and fitting guide is intended for the eye care professional,
but should be made available to patients upon request. The eye care professional should provide the patient with the patient instructions that pertain to
the patient's prescribed lens and the recommended wearing schedule.
DESCRIPTION:
The BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A) Visibility Tinted
Contact Lens is a soft hydrophilic contact lensthat is a front surface asphere
consisting of multiple aspheric zones with a spherical base curve. The most
plus power is in the center of the lens, progressing to more minus in the
periphery. The lens material, balafilcon A, is a copolymer of a silicone vinyl
carbamate, N-vinyl-pyrrolidone, a siloxane crosslinker and a vinyl alanine wetting monomer, and is 36% water by weight when immersed in a sterile borate
buffered saline solution. This lens is tinted blue with up to 300 ppm of
Reactive Blue Dye 246.
The physical / optical properties of the lens are:
Specific Gravity: 1.064
Refractive Index: 1.426
Light Transmittance: C.I.E. value - at least 95%
Water Content: 36%
-11
Oxygen Permeability: 91 x 10
The PureVision Multi-Focal Contact Lenses, with the AerGel™ lens material, are
manufactured by a cast molding process and are surface treated by the
Performa™ surface treatment process which transforms hydrophobic silicone to
hydrophilic silicate.
[cm3O2(STP) x cm]/(sec x cm2x
mmHg) @ 35° C Polarographic Method
(Boundary and Edge Corrected)
-11
[cm3O2(STP) x cm]/(sec x cm2x
101 x 10
mmHg) @ 35°C Polarographic Method
(Boundary Corrected, Non-Edge Corrected)
123
LENS PARAMETERS AVAILABLE:
The BAUSCH & LOMB PureVision® Multi-Focal (balafilcon A) Visibility Tinted
Contact Lens is a hemispherical shell of the following dimensions:
Diameter: 14.0mm
Center Thickness: 0.05mm to 0.50mm
Base Curve: 8.6mm
Sphere Powers: +6.00D to -10.00D (0.25D increments)
ADD Powers: Low (+0.75D to +1.50D) and High (+1.75D to +2.50D)
HOW THE LENS WORKS (ACTIONS):
In its hydrated state, the BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A)
Visibility Tinted Contact Lens when placed on the cornea, acts as a refracting
medium to focus light rays on the retina.
INDICATIONS:
The BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A) Visibility Tinted
Contact Lens is indicated for daily wear or extended wear from 1 to 30 days
between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting
astigmatism of up to 2.00 diopters or less, that does not interfere with visual
acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or
Disposable Wear in spherical powers ranging from +6.00D to -18.00D when prescribed for up to 30 days of extended wear and from +20.00D to –20.00D for
daily wear or extended wear up to 7 days with add powers ranging from
+0.75D to +5.00D.
te: See the WARNINGS reference to the relationship between lens wearing
No
schedule and corneal complications.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the PureVision
Multi-Focal Contact Lens is to be cleaned, rinsed and disinfected each time it is
removed from the patient’s eye and discarded after the recommended wearing
period prescribed by the eye care professional. The lens may be disinfected
using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the PureVision Multi-Focal Contact Lens
is to be discarded after each removal.
CONTRAINDICATIONS (REASONS NOT TO USE):
DO NOT USE the BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A)
Visibility Tinted Contact Lens when any of the following conditions exist:
• Acute and subacute inflammation or infection of the anterior chamber
of the eye
• Any eye disease, injury, or abnormality that affects the cornea,
conjunctiva, or eyelids
• Severe insufficiency of lacrimal secretion (dry eyes)
• Corneal hypoesthesia (reduced corneal sensitivity)
• Any systemic disease that may affect the eye or be exaggerated by
wearing contact lenses
• Allergic reactions of ocular surfaces or adnexa (surrounding tissue) that
may be induced or exaggerated by wearing contact lenses or use of
contact lens solutions
• Allergy to any ingredient, such as mercury or Thimerosal, in a solution
which is to be used to care for the PureVision Mulit-Focal Contact Lens
• Any active corneal infection (bacterial, fungal, or viral)
• If eyes become red or irritated
WARNINGS:
After a thorough eye examination, including appropriate medical background,
patients should be fully apprised by the prescribing eye care professional of all
the risks with contact lens wear. Patients should be advised of the following
warnings pertaining to contact lens wear:
• Problems with contact lenses and lens care products could
result in serious injury to the eye. It is essential that patients
follow their eye care professional's direction and all labeling
instructions for proper use of lenses and lens care products,
including the lens case. Eye problems, including corneal
ulcers, can develop rapidly and lead to loss of vision.
• When prescribed for Frequent/Planned Replacement Wear, the
need for strict compliance with the care regimen including
cleaning of the lens case, wearing restrictions, wearing
schedule, and follow-up visit schedule should be emphasized
to the patient.
• Studies have shown that contact lens wearers who are
smokers have a higher incidence of adverse reactions than
nonsmokers.
EXTENDED WEAR
• The risk of microbial keratitis has been shown to be greater among users of
extended wear contact lenses than among users of daily wear contact lenses. The risk among extended wear lens users increases with the number of
consecutive days that the lenses are worn between removals, beginning
with the first overnight use.
Some researchers believe that these complications are caused by one or
more of the following: a weakening of the cornea's resistance to infections,
particularly during a closed-eye condition, as a result of hypoxia; an eye
environment which is somewhat more conducive to the growth of bacteria
and other microorganisms, particularly when a regular periodic lens
removal and disinfecting or disposal schedule has not been adhered to by
the patient; improper lens disinfection or cleaning by the patient; contamination of lens care products; poor personal hygiene by the patient; patient
unsuitability to the particular lens or wearing schedule; accumulation of
lens deposits; damage to the lens; improper fitting; length of wearing time;
and the presence of ocular debris or environmental contaminants.
• While the great majority of patients successfully wear contact lenses,
extended wear of lenses also is reported to be associated with a higher
incidence and degree of epithelial microcycsts and infiltrates, and endothelial polymegathism, which require consideration of discontinuation or restriction of extended wear. The epithelial conditions are reversible upon
discontinuation of extended wear.
The long term risk of microbial keratitis has not been determined for this
lens. Post marketing studies are in progress.
The reversibility of endothelial effects of contact lens wear has not been
conclusively established. As a result, professionals views of extended wearing times vary from not prescribing extended wear at all to prescribing
flexible wearing times from occasional overnight wear to prescribing extended wearing periods from 1 to 30 days with specified intervals of no lens
wear for certain patients, with follow-up visits, and with proper care
regimen.
• If a patient experiences eye discomfort, excessive tearing, vision changes,
or redness of the eye, the patient should be instructed to immediately
remove lenses and promptly contact his or her eye care professional.
PRECAUTIONS:
Precautions for Eye Care Professionals:
• Due to the small number of patients enrolled in clinical investigation of
lenses, all refractive powers, design configurations, or lens parameters available in the lens material are not evaluated in significant numbers.
Consequently, when selecting an appropriate lens design and parameters,
the eye care professional should consider all characteristics of the lens that
can affect lens performance and ocular health, including oxygen permeability, wettability, central and peripheral thickness, and optic zone diameter.
The oxygen transmissibility is below the established threshold required to
prevent overnight corneal edema for portions of the power range, including
some plus powers and some low minus power lenses.
study of the PureVision (spherical) lens, the rate of infiltrative keratitis was
found to be higher with higher lens powers (see Clinical Study section of the
package insert).
• The potential impact of these factors on the patient's ocular health should
be carefully weighed against the patient's need for refractive correction;
therefore, the continuing ocular health of the patient and lens performance
on eye should be carefully monitored by the prescribing eye care professional.
• Patients who wear aspheric contact lenses, such as the Bausch & Lomb
PureVision Multi-Focal, to correct presbyopia may not achieve the best corrected visual acuity for either far or near vision. Visual requirements vary
with the individual and should be considered when selecting the most
appropriate type of lens for each patient.
1
Holden BA, Mertz GW. Critical Oxygen Levels to Avoid Corneal Edema for
Daily and Extended Wear Contact Lenses. Invest Ophthalmol Vis Sci 25:1162, 1984.
1
In the U.S. clinical
456
• Eye care professionals should instruct the patient to REMOVE A LENS
IMMEDIATELY if an eye becomes red or irritated.
• Fluorescein, a yellow dye, should not be used while the lenses are on the
eyes. The lenses absorb this dye and become discolored. Whenever fluorescein is used in eyes, the eyes should be flushed with sterile saline solution
that is recommended for in-eye use.
• The patient should be instructed to always discard disposable lenses and
lenses worn on a frequent/planned replacement schedule after the recommended wearing schedule prescribed by the eye care professional.
• Some patients will not be able to tolerate continuous wear even if able to
tolerate the same or another lens on a daily wear basis. Some patients
who are able to tolerate continuous wear will not be able to wear their
lenses continuously for 30 days. Patients should be carefully evaluated
for continuous wear prior to prescription and dispensing, and eye care
professionals should conduct early and frequent follow-up examination
to determine ocular response to continuous wear.
• As with any contact lens, follow-up visits are necessary to assure the
continuing health of the patient's eyes. The patient should be instructed
as to a recommended follow-up schedule.
• Aphakic patients should not be fitted with PureVision Contact Lenses
until the determination is made that the eye has healed completely.
Eye care professionals should carefully instruct patients about the following
lens care and safety precautions. It is strongly recommended that patients
be provided with a copy of the PureVision Multi-Focal Patient Information
Booklet available from BAUSCH & LOMB and understand its contents prior
to dispensing the lenses.
Handling Precautions:
• Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions, soaps, creams, deodorants, or sprays in the eyes or on
the lenses. It is best to put on lenses before putting on makeup. Waterbase cosmetics are less likely to damage lenses than oil-base products.
• Be sure that before leaving the eye care professional's office, the patient
is able to remove lenses promptly or have someone else available to
remove them.
• Be certain that the fingers or hands are free of foreign materials before
touching lenses, as microscopic scratches of the lenses may occur,
causing distorted vision and/or injury to the eye.
• Always handle lenses carefully and avoid dropping them.
• Do not touch the lens with fingernails.
• Carefully follow the handling, insertion, removal, cleaning disinfecting,
storing and wearing instructions in the Patient Information Booklet for
the PureVision Contact Lenses and those prescribed by the eye care
professional.
• Never use tweezers or other tools to remove lenses from the lens container
unless specifically indicated for that use. Pour the lens into the hand.
Solution Precautions:
Do not use the Allergan Ultracare Disinfecting System or any of its components (Ultracare Disinfecting Solution, Ultracare Neutralizing Tablets, Lens
Plus Daily Cleaner, and Ultrazyme Enzymatic Cleaner) to clean and disinfect
the PureVision Multi-Focal Contact Lens because the lens dimensions will be
altered.
• Always use fresh unexpired lens care solutions.
• Always follow directions in the package inserts for the use of contact
lens solutions.
• Sterile unpreserved solutions, when used, should be discarded after the
time specified in the labeling directions.
• Always keep the lenses completely immersed in the recommended
storage solution when lenses are not being worn (stored). Prolonged
periods of drying will damage lenses. Follow the lens care directions for
Care for a Dried Out (Dehydrated) Lens in the patient information booklet
if lens surface does become dried out.
• Do not use saliva or anything other than the recommended solution for
lubricating or wetting lenses.
• Tap water, distilled water or homemade saline should not be used as a
substitute for any component in the lens care regimen since they have
been associated with an Acanthamoeba keratitis infection.
• Never use conventional hard contact lens solutions that are not also
recommended for use with prescribed lenses.
• Do not mix or alternate lens care systems or solutions unless indicated in
the lens care system labeling.
• Do not heat the chemical disinfection solution or lenses.
Lens Wearing Precautions:
• Never wear lenses beyond the period recommended by the eye care
professional.
• If the lens sticks (stops moving) on the eye, follow the recommended
directions on Care for a Sticking Lens. The lens should move freely on
the eye for the continued health of the eye. If nonmovement of the lens
continues, the patient should be instructed to immediately consult his or
her eye care professional.
• Avoid, if possible, all harmful or irritating vapors and fumes while
wearing lenses.
• If aerosol products are used while wearing lenses, exercise caution and
keep eyes closed until the spray has settled.
Lens Case Precautions:
• Contact lens cases can be a source of bacterial growth. To prevent
contamination and to help avoid serious eye injury, always empty and
rinse the lens case with fresh, sterile rinsing solution and allow to air dry.
• Lens cases should be replaced at regular intervals as recommended by
the lens case manufacturer or eye care professional.
Topics to Discuss with the Patient:
• As with any contact lens, follow-up visits are necessary to assure the
continuing health of the eyes. The patient should be instructed as to a
recommended follow-up schedule.
• Patients should be advised about wearing lenses during sporting and water
related activities. Exposure to water while wearing contact lenses in activities
such as swimming, water skiing and hot tubs may increase the risk of ocular
infection including but not limited to Acanthamoeba keratitis.
• Always contact the eye care professional before using any medicine in
the eyes.
Who Should Know That the Patient is Wearing Contact Lenses:
• Patients should inform their doctor (health care professional) about being
a contact lens wearer.
• Patients should always inform their employer of being a contact lens
wearer. Some jobs may require the use of eye protection equipment or
may require that you do not wear lenses.
ADVERSE REACTIONS:
The patient should be informed that the following problems may occur:
• Eyes stinging, burning, itching (irritation), or other eye pain
• Comfort is less than when lens was first placed on eye
• Abnormal feeling of something in the eye (foreign body, scratched area)
• Excessive watering (tearing) of the eyes
• Unusual eye secretions
• Redness of the eyes
• Reduced sharpness of vision (poor visual acuity)
• Blurred vision, rainbows, or halos around objects
• Sensitivity to light (photophobia)
• Dry eyes
If the patient notices any of the above, he or she should be instructed to:
• Immediately remove the lenses.
• If the discomfort or problem stops, then look closely at the lens. If the
lens is in any way damaged, do not put the lens back on the eye. Place
the lens in the storage case and contact the eye care professional. If the
lens has dirt, an eyelash, or other foreign body on it, or the problem
stops and the lens appears undamaged, the patient should thoroughly
clean, rinse, and disinfect the lenses; then reinsert them. After
reinsertion, if the problem continues, the patient should immediately
remove the lenses and consult his or her eye care professional.
If the above symptoms continue after removal of the lens, or upon
reinsertion of a lens, or upon insertion of a new lens, the patient should
immediately remove the lenses and contact his or her eye care
professional or physician, who must determine the need for examination,
treatment or referral without delay. (See Important Treatment Information
for Adverse Reactions.) A serious condition such as infection, corneal
ulcer, corneal vascularization, or iritis may be present, and may progress
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rapidly. Less serious reactions such as abrasions, epithelial staining or
bacterial conjunctivitis must be managed and treated carefully to avoid
more serious complications.
Important Treatment Information for Adverse Reactions
Sight-threatening ocular complications associated with contact lens wear can
develop rapidly, and therefore early recognition and treatment of problems are
critical. Infectious corneal ulceration is one of the most serious potential complications, and may be ambiguous in its early stage. Signs and symptoms of
infectious corneal ulceration include discomfort, pain, inflammation, purulent
discharge, sensitivity to light, cells and flare and corneal infiltrates.
Initial symptoms of a minor abrasion and an early infected ulcer are sometimes
similar. Accordingly, such epithelial defect, if not treated properly, may develop
into an infected ulcer. In order to prevent serious progression of these conditions, a patient presenting symptoms of abrasions or early ulcers should be evaluated as a potential medical emergency, treated accordingly, and be referred to a
corneal specialist when appropriate. Standard therapy for corneal abrasions such
as eye patching or the use of steroids or steroid/antibiotic combinations may
exacerbate the condition. If the patient is wearing a contact lens on the affected
eye when examined, the lens should be removed immediately and the lens and
lens care products retained for analysis and culturing.
CLINICAL STUDY:
The following clinical results are provided for informational purposes. It is
important to note that the results below are from a study conducted with the
PureVision Contact Lens which has the same lens material, but different lens
design (spherical). The study was conducted with subjects not requiring presbyopic correction
STUDY DESCRIPTION
Study Design
The objective of this 12-month study was to evaluate the safety and efficacy of
the BAUSCH & LOMB® PureVision® (balafilcon A) Visibility Tinted Contact
Lenses worn on a 30-day continuous wear basis, compared to a conventional
Control lens worn on a 7-day continuous wear basis. A total of 1640 eyes (820
subjects) were enrolled into this study. Subjects were fitted with a PureVision
Contact Lens on one eye while the contralateral eye was fitted with a Control
lens. Subjects were instructed to replace the PureVision Contact Lens with a
new lens every 30 days, and to wear the Control lens overnight for up to six
consecutive nights per week. Eyes had one night without lens wear after the
scheduled removal. The Control lens was to be replaced with a new lens
every 14 days.
Six hundred ten (610) subjects completed the one-year study. Ten subjects
discontinued in the daily wear adaptation period, 182 subjects discontinued
during the extended wear phase and 18 subjects were not dispensed lenses.
Patient Assessments
Subjects were evaluated at follow-up visits scheduled after 24 hours,
10 days, 1 month, 3 months, 6 months, 9 months, and 12 months of
lens wear.
Demographics
Subject recruitment was open to adapted and unadapted contact lens wearers.
There were no restrictions as to the subject’s gender or occupation, but subjects were required to be of legal age (typically 18 or 21) and have the legal
capacity to volunteer. The ages of the subjects ranged from 18 to 74 years of
age, with a mean age of 33.6, and included 574 females and 228 males, with
a ratio of 2.52 females to every male. For the PureVision Contact Lens the
power range used was –0.50D to –9.00D. For the Control lens the power range
was –0.50D to –8.50D.
The previous lens wearing experience of the subjects that participated in the
study was 5% no lens wear, 43% daily wear, and 51% continuous wear. The
refractive errors of the subjects ranged from –0.25D to –11.75D, and included
up to –2.00D of astigmatism.
SUMMARY OF DATA ANALYSES
Summary of Data Analyses
The key endpoints for this study were:
1. grade 2 and higher slit lamp findings (safety endpoint),
2. grade 2 and higher corneal infiltrates (safety endpoint), and
3. contact lens corrected visual acuity worse than 20/40 (efficacy endpoint).
For each key endpoint, the rates (incidents of endpoint/number of eyes) experienced by eyes in the PureVision Contact Lens and Control lenses were calculated. The difference in rates between the two lens types was determined and
a 95% confidence interval for the difference was calculated. For each key
endpoint a “clinically significant difference” in the rates was established
before the study started. These “clinically significant differences” were as follows: 10% for total slit lamp findings ≥ Grade 2, 5% for corneal infiltrates ≥
Grade 2, and 5% for the acuity endpoint. For example, if the true rates of
endpoint infiltrates in the subject population were 9.99% in the PureVision
Contact Lens and 5% in the Control lens, these rates would be considered substantially equivalent (difference <5%).
In order to be successful for a given endpoint, the upper 95% confidence limit
for the difference in the study rates had to be less than the pre-established
“clinically significant difference.” This means that we are 95% confident that
the true difference is within tolerance. The safety and efficacy goals were met
for all three key endpoints. Results are as follows:
Relative
PureVision Control PureVision/ Difference Confidence Significant
Endpoint n % n % Control in % Level Difference
Slit Lamp
Findings
≥
Grade 2 138 17.5% 139 17.6% 1.0 -0.1% 2.6% 10.0%
Corneal
≥
Infiltrates
Grade 2 23 2.9% 10 1.3% 2.3 1.6% 2.9% 5.0%
Visual Acuity
Worse than
20/40 0 0.0% 2 0.3% 0.0 -0.3% 0.1% 5.0%
Risk Upper 95% Clinically
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.
Graded Slit Lamp Findings ( ≥ Grade 2)
Tarsal Conjunctival Abnormalities 3.9% 3.9%
Corneal Neovascularization 1.0% 1.7%
Ungraded Slit Lamp Findings
Other Anterior Segment Abnormalities
External Adnexa Abnormalities 2.7% 2.7%
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.
Any Finding
Corneal Staining 8.2% 8.4%
Limbal Injection 3.7% 4.3%
Bulbar Injection 5.2% 4.7%
Corneal Infiltrates
Epithelial Edema 1.3% 1.4%
Epithelial Microcysts 1.0% 1.0%
Conjunctivitis 2.4% 2.0%
Corneal Striae 0.0% 0.3%
PureVision Control
1,2
17.5% 17.6%
1
2.9% 1.3%
3
13.2% 13.8%
10 11
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 Plano to –3.00 1.7%
Lens Power ( ≥ Grade 2)
Corneal Infiltrates
-3.25 to –6.00 3.2%
>-6.00 6.4%
Total 2.9%
Control 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 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 PureVision Multi-Focal Contact Lenses should be
chosen for their motivation to wear contact lenses, general health and coop-
12
eration. 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
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® Multi-Focal Low Add: +0.75D to +1.50D.
• Bausch & Lomb PureVision® Multi-Focal High Add: +1.75D to +2.50D
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 c. in decreased illumination
b. at near in any position of gaze 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, then every 6 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 hyper-
emia 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 pro-
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fessional 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 minus cylinder form, ignore the cylinder) and vertex, if necessary.
B. Select the appropriate ADD.
• Bausch & Lomb PureVision® Multi-Focal Low Add: +0.75D to +1.50D.
• Bausch & Lomb PureVision® Multi-Focal High Add: +1.75D to +2.50D.
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 PureVision
Multi-Focal 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 danger-
ous 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 diopter 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
16 17 18
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 PureVision
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 Wear: For complete information concerning
the care, cleaning and disinfection of contact lenses refer to the PureVision
Multi-Focal (balafilcon A) Visibility Tinted Contact Lens Patient Information
Booklet.
Disposable Wear: For complete information concerning emergency lens care,
refer to the PureVision Multi-Focal 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® 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
1-800-828-9030
In New York State: 1-800-462-1720
In Canada: 1-888-459-5000
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. Store lenses at room temperature (60°F - 80°F, 15°C - 25°C)
Bausch & Lomb Incorporated
Rochester, NY 14609
© Bausch & Lomb Incorporated. All rights reserved worldwide.
Bausch & Lomb, Path Design, Performa, AerGel and PureVision are trademarks
of Bausch & Lomb Incorporated.
Other brand names/product names are trademarks of their respective owners
Covered by and/or licensed under one or more of the following US patents:
5610252, 4997897, 5815239, 5760100; 5789461; 5849811; 5766999; 5965631
and other patents. Printed in U.S.A.
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
Storage Temperature
Diameter
Use By Date (expiration date)
Batch Code
Diopter (lens power)
Authorized representative in European Community
Caution: Federal law restricts this device to sale by or on
the order of a licensed practitioner.
BC Base Curve
ADD Low or High Add power
8044101
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