PACKAGE INSERT / FITTING GUIDE
Multi-Focal
For Presbyopia
CAUTION: Federal law restricts this device to
sale by or on the order of a licensed practitioner.
© Bausch & Lomb Incorporated. All rights reserved worldwide.
®/TM are trademarks of Bausch & Lomb Incorporated.
Other product/brand names are trademarks of their respective owners.
Name and Address of Manufacturer:
Bausch & Lomb Incorporated
1400 North Goodman Street
Rochester, New York, USA 14609
Printed in the U.S.A.
SL-7343
8128800
SYMBOL REFERENCE GUIDE
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Caution: Federal law restricts this device to sale by or on
the order of a licensed practitioner
Diopter (Lens Power)
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Low or High Add Power
Storage Temperature
TABLE OF CONTENTS
Important 3
Description 3
Lens Parameters Available 4
How the Lens Works (Actions) 4
Indications 4
Contraindications 5
Warnings 6
Precautions 8
Adverse Reactions 11
Clinical Study 13
Selection of Patients 18
Fitting Procedure 19
Pre-fitting Examination 19
Initial Lens Power Selection 19
Initial Lens Evaluation 20
Criteria of a Well-fitted Lens 20
Characteristics of a Tight (Steep) Lens 20
Characteristics of a Loose (Flat) Lens 21
Follow-up Care 21
Practitioner Fitting Sets 22
Wearing Schedule 22
Multi-Focal Fitting Guidelines 23
Patient Selection 23
Lens Selection 23
Lens Fitting 23
Symptom Resolution 23
Patient Education 24
Monovision Fitting Guidelines 24
Patient Selection 24
Eye Selection 25
Special Fitting Considerations 25
Near Add Determination 26
Trial Lens Fitting 26
Adaptation 27
Other Suggestions 27
Handling of Lens 28
Patient Lens Care Directions 28
Frequent Replacement and Disposable Wear 28
Care for a Sticking (Nonmoving) Lens 28
Care for a Dried Out (Dehydrated) Lens 29
Emergencies 29
Reporting of Adverse Reactions 30
How Supplied 30
2
IMPORTANT
This package insert and fitting guide has been developed to provide professionals with
information covering characteristics of the Bausch + Lomb PureVision
(balafilcon A) Visibility Tinted Contact Lens and to illustrate fitting procedures. It
is effective as of June 2013 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® 2 Multi-Focal (balafilcon A) Visibility Tinted Contact
Lens is a soft hydrophilic contact lens that 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.
®
2 Multi-Focal
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%
Oxygen Permeability: 91 x 10
The Bausch + Lomb PureVision
Lens, with AerGel™ technology lens material, are manufactured by a cast molding
process and are treated by the Performa™ surface treatment process which transforms
hydrophobic silicone to hydrophilic silicate. The Bausch + Lomb PureVision2 MultiFocal (balafilcon A) Visibility Tinted Contact Lens may be prescribed for Frequent/
Planned Replacement or Disposable Wear.
–11
[cm3O2(STP) x cm]/(sec x cm2 x mmHg) @
35° C Polarographic Method
(Boundary and Edge Corrected)
–11
101 x 10
[cm3O2(STP) x cm]/(sec x cm2 x mmHg)
@ 35°C Polarographic Method
(Boundary Corrected, Non-Edge Corrected)
®
2 Multi-Focal (balafilcon A) Visibility Tinted Contact
3
LENS PARAMETERS AVAILABLE
The Bausch + Lomb PureVision®2 Multi-Focal (balafilcon A) Visibility Tinted Contact
Lens is a hemispherical shell of the following dimensions:
Diameter: 14.0mm
Center Thickness: Varies with power
(0.07mm at -3.00D)
Base Curve: 8.6mm
Powers (Spherical): +6.00D to -10.00D in (0.25D increments)
Add Powers: Low and High
*Additional powers may be introduced over time, check for product availability.
HOW THE LENS WORKS (ACTIONS)
In its hydrated state, the Bausch + Lomb PureVision®2 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®2 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, 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.
Note: See the WARNINGS reference to the relationship between lens wearing
schedule and corneal complications.
FREQUENT / PLANNED REPLACEMENT WEAR
When prescribed for Frequent / Planned Replacement Wear, the Bausch + Lomb
®
PureVision
2 Multi-Focal (balafilcon A) Visibility Tinted 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 Bausch + Lomb PureVision®2 Multi-Focal
(balafilcon A) Visibility Tinted Contact Lens is to be discarded after each removal.
4
CONTRAINDICATIONS
(REASONS NOT TO USE)
DO NOT USE the Bausch + Lomb PureVision®2 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 Bausch + Lomb PureVision
Tinted Contact Lens
• Any active corneal infection (bacterial, fungal, or viral)
• If eyes become red or irritated
®
2 Multi-Focal (balafilcon A) Visibility
5
WARNINGS
After a thorough eye examination, including appropriate medical background, patients
should be fully apprised by the prescribing 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.
• 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.
6
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
microcysts 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 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.
7
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 plus powers and
some low minus power lenses.
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 prescribing
eye care professional should carefully monitor the continuing ocular health of the
patient and lens performance on eye.
• Patients who wear aspheric contact lenses, such as the Bausch + Lomb PureVision2
Multi-Focal (balafilcon A) Visibility Tinted Contact Lens, 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.
• 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.
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 study of the PureVision (spherical)
8
• 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 Bausch + Lomb PureVision
(balafilcon A) Visibility Tinted 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 Bausch + Lomb PureVision
Tinted Contact Lens 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. Water-base 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.
®
2 Multi-Focal (balafilcon A) Visibility
®
2 Multi-Focal
• 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 Bausch + Lomb
®
2 Multi-Focal (balafilcon A) Visibility Tinted Contact Lens and those
PureVision
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 Bausch + Lomb PureVision
Contact Lens because the lens dimensions will be altered.
®
2 Multi-Focal (balafilcon A) Visibility Tinted
9
Eye injury due to irritation or infection may result from lens contamination. To reduce
the risk of contamination, review the appropriate manufacturer’s labeled lens care
instructions with the patient.
• 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.
10
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 monthly or as frequently 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
11
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, the patient should look closely at the lens. If the
lens is in any way damaged, do not put the lens back on the eye. The patient should
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 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.
12
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 Bausch + Lomb
®
PureVision
(balafilcon A) Visibility Tinted Contact Lens which has the same lens
material, but different lens design. 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
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.
13
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:
PureVision Control
Endpoint n % n %
Slit Lamp
Findings ≥
138 17.5% 139 17. 6% 1.0 -0.1% 2.6% 10.0%
Grade 2
Corneal
Infiltrates ≥
23 2.9% 10 1.3% 2.3 1.6% 2.9% 5.0%
Grade 2
Visual
Acuity Worse
0 0.0% 2 0.3% 0.0 -0.3% 0.1% 5.0%
than 20/40
Relative
Risk/
PureVision
Control
Difference
in %
Upper
95%
Confidence
Level
Clinically
Significant
Difference
14
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 ≥
Tarsal Conjunctival Abnormalities 3.9% 3.9%
Corneal Infiltrates
Epithelial Microcysts 1.0% 1.0%
Corneal Neovascularization 1.0% 1.7%
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.
Grade 2 and ungraded slit lamp findings.
PureVision Control
Graded Slit Lamp Findings ( ≥ Grade2 )
1,2
Any Finding
Corneal Staining 8.2% 8.4%
Limbal Injection 3.7% 4.3%
Bulbar Injection 5.2% 4.7%
1
Epithelial Edema 1.3% 1.4%
Ungraded Slit Lamp Findings
Conjunctivitis 2.4% 2.0%
Corneal Striae 0.0% 0.3%
3
17.5% 1 7.6 %
2.9% 1.3%
13.2% 13.8%
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.
Lens Power
PureVision
Control
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.
Plano to – 3.00 1.7 %
– 3.25 to – 6.00 3.2 %
> – 6.00 6.4 %
Total 2.9 %
Lens Power
Plano to – 3.00 0.9 %
– 3.25 to – 6.00 1.5 %
> – 6.00 1.3 %
Total 1.3 %
Corneal Infiltrates
(≥ Grade 2)
Corneal Infiltrates
(≥ Grade 2)
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 followup 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
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.
®
2 Multi-Focal (balafilcon A)
18171615
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
• Bausch + Lomb
PureVision
PureVision
®
2 Multi-Focal Low Add.
®
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
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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.
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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.
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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.
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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
• Bausch + Lomb
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:
PureVision
PureVision
®
2 Multi-Focal Low Add.
®
2 Multi-Focal High Add.
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
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.
®
2 Multi-Focal (balafilcon A) Visibility
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.
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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.
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• 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
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
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.
®
2 Multi-Focal (balafilcon A) Visibility Tinted Contact
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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
®
2
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.
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REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in patients wearing
Bausch + Lomb PureVision
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.
®
2 Multi-Focal (balafilcon A) Visibility Tinted Contact
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