Bausch & Lomb Boston Multivision GP Contact Lenses User Manual
P RO F E S S I O N A L
FITTING AND
I N F O R M AT I O N
G U I D E
BOSTON® MultiVision
(enflufocon A) Contact Lens
Contact Lenses for Daily Wear
TABLE OF CONTENTS
Introduction
Product Description
Lens Parameters Available
Indications
Contraindications, Warnings, Precautions,
and Adverse Reactions
Selection of Patients
Pre-Fitting Examination
Fitting Guide
In-Office Care of Trial Lenses
Recommended Initial Wearing Schedule
Clinical Assessment
Criteria of a Well-fitted Lens
Optimizing Fitting Characteristics
Problem Solving
Modified Monovision Fitting Guidelines
Patient Lens Care Directions
Laboratory Lens Cleaner
Care for a Sticking (Non-Moving) Lens
Reporting of Adverse Reactions
How Supplied
LENS PARAMETERS AVAILABLE
Power Range -20.00D to +20.00D
Diameter 9.6 mm
Base Curve Range 7.30 mm to 8.30 mm
Add Powers Nominal Add Power
INTRODUCTION
Boston® MultiVision (enflufocon A) Contact Lenses are made from the Boston ES® (enflufocon A)
fluoro silicon acrylate material with a water content of <1% by weight.
For a complete listing of available lens parameters, please refer to LENS PARAMETERSAVAILABLE.
PRODUCTDESCRIPTION
The Boston ES® (enflufocon A) is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer
including a color additive (D &C Green No.6) with an ultraviolet absorber (Uvinul D-49).
The lenses described above can have a center thickness of 0.10 to ~0.69 mm that will vary with lens design and
power.
The physical/optical properties of the lens are:
Specific Gravity 1.22
Refractive Index 1.443
Light Absorbance (640 nm) 10.2 (absorbance units/inch)
Surface Character Hydrophobic
Wetting Angle 52°
Water Content <1%
Oxygen Permeability 36* (18**)
-11
{x 10
(cm3O
• cm)/(cm2• sec • mmHg) @ 35° C}
2
*gas to gas method
**polarographic method (ISO/Fatt)
Rigid Gas Permeable
in 0.12D increments
in 0.1 mm increments
+1.50 D
B O S TON® ES - 0.07 mm thick BOSTON ES (Blue)
CORNEA - Human cornea from a 24-year-old person as described in Lerman, S., Radiant Energy and the Eye,
MacMillan, New Yo rk, 1980, p. 5 8 .
C RY S TALLINE LENS - Human crystalline lens from a 25-year-old person as described in Wa x l e r , M., Hitchins,
Optical Radiation and Visual Health, CRC P r e s s, Boca Raton, Florida, 1986, p.19, figure 5.
V.M.,
NOTE
The effectiveness of wearing UV-absorbing contact lenses in preventing or reducing the incidence of ocular disorders associated with exposure to UV light has not been established at this time.
WARNING
UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing
goggles or sunglasses. Persons should continue to use their protective UV-absorbing eyewear as directed.
INDICATIONS
The BOSTON® MultiVision (enflufocon A) Contact Lens is indicated for daily wear for the correction of refractive
ametropia (myopia, hyperopia, astigmatism and presbyopia) in not aphakic persons with non-diseased eyes, who
exhibit astigmatism of 4.00 diopters or less and can obtain satisfactory visual acuity. The lens provides a nominal functional add of +1.50 diopters. The lens may be disinfected using a chemical disinfecting system only.
CONTRAINDICATIONS (REASONSNOT TO USE)
DO NOT USE the BOSTON® MultiVision (enflufocon A) Contact Lens when any of the following conditions exist:
• Acute or 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 that may be induced or exaggerated by wearing contact lenses
or using contact lens solutions
• Allergy to any ingredient in a solution which is to be used to care for the BOSTON®MultiVision (enflufocon A)
Contact Lenses
• Any active corneal infection (bacterial, fungal, or viral)
• Red or irritated eyes
WARNINGS
Patients should be advised of the fo l l owing wa rnings pertaining to contact lens we a r:
• Problems with contact lenses and lens care products could result in serious injury to the eye. It is essential that
patients follow their eyecare practitioner’s directions 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.
• Daily wear lenses are not indicated for overnight wear, and patients should be instructed not to wear lenses
while sleeping.Clinical studies have shown that the risk of serious adverse reactions is increased when daily
wear lenses are worn overnight.
• Studies have shown that contact lens wearers who are smokers have a higher incidence of adverse reactions
than nonsmokers.
Practitioner Note: BOSTON® MultiVision
( e n f l u focon A) Contact Lenses are not sterile when shippedfrom the Authorized BOSTONManufacturer.Prior to
dispensing, clean and disinfect the lens(es) according to the appropriate lens 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 eyecare practitioner.
PRECAUTIONS
•Special Precautions for Eyecare Practitioners:
• 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 eyecare practitioner should consider all characteristics of the lens that can affect lens performance and ocular health, including oxygen permeability, wettability, central and peripheral thickness.
• 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 the eye should be carefully monitored by the prescribing eyecare practitioner.
• Before leaving the eyecare practitioner’s office, the patient should be able to properly remo ve lenses or should
have someone else available who can remove the lenses for him or her.
• Eyecare practitioners should instruct the patient to remove the lenses immediately if the eye becomes red or
irritated.
• The presence of the ultraviolet (UV) light absorber in the BOSTON® MultiVision (enflufocon A)l contact lens
material may require equipment enhancement to visualize fluorescein patterns adequately.(Refer to the FITTING PROCEDURE for detailed instructions.)
Eyecare practitioners should carefully instruct patients about the following care regimen and safety precautions:
• Different solutions often cannot be used together, and not all solutions are safe for use with all lenses. Use only
recommended solutions.
if not aphakic
orescein pooling, is normal as long as there is not a excessive amount of edge lift, i.e., creating bubble formation
at the edge or causing the lens to be unstable.
The presence of the UV-absorber in the BOSTON® MultiVision (enflufocon A) contact lens may require equipment enhancement to visualize fluorescein patterns adequately. A simple, inexpensive approach is the use of an
auxiliary yellow Kodak Wratten #12 filter in conjunction with the cobalt blue filter of the biomicroscope.
Slit Lamp Application:
1. All customary light intensities and filter settings (Cobalt Blue) are left in place.
2. The Kodak Wratten Filter #12* (yellow) is secured on the patient side of the slit lamp microscope with a small
piece of adhesive tape.
– Do not heat the conditioning/storage solution and lenses.Keep them away from extreme heat.
– Always use fresh unexpired lens care solutions.
– Always follow directions in the package inserts for the use of contact lens solutions.
– Use only a chemical (not heat) lens care system.Use of a heat (thermal) care system can warp the
BOSTON® MultiVision (enflufocon A) Contact Lenses.
– Sterile unpreserved solutions, when used, should be discarded after the time specified in the labeling direc-
tions.
– Do not use saliva or anything other than the recommended solutions for lubricating or wetting lenses.
– A l ways keep the lenses completely immersed in the recommended storage solution when the lenses are not
being wo rn (stored).If dry storage is desired to store the lenses for a longer period of time, they must first be
cleaned, rinsed with water and carefully dried by blotting with a soft lint-free tissue prior to being placed in a
clean, dry lens storage case.I d e a l l y , these lenses should be cleaned and disinfected prior to insert i o n .
• If the lens sticks (stops moving) on the e ye, follow the recommended directions on Care for a Sticking Lens.
The lens should move freely on the eye for the continued health of the e ye.If nonmovement of the lens continues, the patient should be instructed to immediately consult his or her eyecare practitioner.
• A l ways wash and rinse hands before handling lenses.Do not get cosmetics, lotions, soaps, creams, deodora n t s, or
s p rays in the eyes or on the lenses.It is best to put on lenses before putting on make u p.Water-based cosmetics are
less likely to damage lenses than oil-based products.
• Do not touch contact lenses with the fingers or hands if the hands are not free of foreign materials, as microscopic scratches on the lenses may occur, causing distorted vision and/or injury to the eye.
• Carefully follow the handling, insertion, removal, cleaning, disinfecting, storing and wearing instructions in the
Patient Instructions for the BOSTON® MultiVision (enflufocon A) Contact Lens and those prescribed by the
eyecare practitioner.
• Never wear lenses beyond the period recommended by the eyecare practitioner.
• If aerosol products such as hair spray are used while wearing lenses, exercise caution and keep eyes closed
until the spray has settled.
• Always handle lenses gently and avoid dropping them on hard surfaces.
• Avoid all harmful or irritating vapors and fumes while wearing lenses.
• Ask the eyecare practitioner about wearing lenses during water activities and other sports.
• Inform the patient to alert their health care practitioner (doctor) that they wear contact lenses.
• Never use tweezers or other tools to remove lenses from the lens case unless specifically indicated for that
use. Pour the lens into the hand.
• Do not touch the lens with fingernails .
• Always contact the eyecare practitioner before using any medicine in the eyes.
• Always inform your employer that you wear contact lenses. Some jobs may require use of e ye protection equipment or may require that the patient not wear contact lenses.
• 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.
ADVERSE EFFECTS
The patient should be informed that the following problems may occur :
• Comfort is less than when lens was first placed on the eye
• Feeling of something in the eye such as a foreign body, scratched area
• Excessive watering (tearing) of the eyes
If the patient notices any of the above symptoms, he or she should be instructed to:
Immediately remove lenses
If the discomfort or problem stops, then closely inspect 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 eyecare practitioner.
If the lens has dirt, an eyelash, or other foreign body on it, or the problem stops and the lens appears undam-
aged, 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 the e ye care practitioner.
The patient should be informed that the following problems may also occur:
• Eyes stinging, burning, itching (irritation), or other eye pain
• 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 symptons, he or she should be instructed to:
Immediately remove lenses
When any of the above problems occur, a serious condition such as infection, corneal ulcer, neovascularization,
or iritis may be present. The patient should be instructed to keep the lens off the eye and seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage.
SELECTION OF PATIENTS
BOSTON® MultiVision (enflufocon A) Contact Lens is a rigid gas permeable lens for the daily wear patient who
may require the correction of visual acuity for myopia, hyperopia, astigmatism or presbyopia.BOSTON®
MultiVision (enflufocon A) Contact Lenses are suitable for patients who have never worn contact lenses, for current PMMA wearers, for patients wanting to upgrade their current rigid gas permeable lenses, as well as for
some patients who have been unsuccessful with soft contact lenses.
PRE-FITTING EXAMINATION
A pre-fitting patient history and examination are necessary to:
• determine whether a patient is a suitable candidate for daily wear presbyopic contact lenses (consider
patient hygiene and mental and physical state),
• make ocular measurements for initial contact lens parameter selection,
• collect and record baseline clinical information to which post-fitting examination results can be compared,
A pre-fitting examination should include distance refraction, keratometry and slit lamp evaluation to rule out
a ny contraindications to contact lens we a r.Careful assessment of the cornea, lids, conj u n c t i va and precorn e a l
tear film establishes a baseline against which the practitioner can compare any changes resulting from contact
lens we a r.
FITTING GUIDE FOR THE BOSTON® MultiVision (enflufocon A) CONTACT LENS
CAUTION: Federal Law Prohibits Dispensing Without a Prescription
Background Information
The BOSTON MultiVision (enflufocon A) Contact Lens consists of a back surface aspheric design intended to
provide distance and intermediate correction with a reading addition of +1.50D. The base curves range from 7.3
mm to 8.3 mm, in 0.1 mm steps, with an overall lens diameter of 9.6 mm. The lens parameters and lens design
were chosen to maximize the ease of fit.
Fitting Principles
Although these lenses may be empirically fit, the best success has been found when they have been fit using
diagnostic (trial) lenses. There are no conversion requirements or special techniques required for fitting this multifocal design. The following guidelines have been provided to maximize the fitting success of the lens.
Initial Base Curve Selection:
If the patient’s corneal cylinder is less than or equal to 1.50D, then the initial base curve selected should corre-
spond to the patient’s flat K reading. If the patient’s corneal cylinder is greater than 1.50D, the initial base curve
selected should correspond to 0.1 to 0.2 mm steeper than the patient’s flat K reading. In general, the goal of the
fit of this multifocal design is to achieve good centration of the lens over the pupil, although superior central position may also be acceptable. The lens must translate well with the blink (1-2 mm) ensuring that the reading portion of the lens moves over the pupillary area upon down gaze. The patient should be instructed to keep their
head erect while moving their gaze to an inferior position (much like progressive addition multifocal spectacle
lenses) to maximally utilize the reading portion.
Example:
Step one:
B.
Measure central corneal curvature and identify the Flat K (lowest dioptric power)
B.In this example – K = 42.75/44.75 @ 90;Flat K = 42.75D (7.90mm)
The “Flat K”is used as a reference point from which the Base Curve Radius is Chosen.
Step two:
B.
Calculate the corneal astigmatism (difference between the flat and steep K).
B.In this example – K=42.75/44.75 @ 90;Corneal Astigmatism = 2.00D
Step three:
B.
Calculate the Base Curve Radius.
B.In this example – K = 42.75/44.75 @ 90;
Flat K = 7.90D
Corneal Astigmatism = 2.00D
Lens Diameter = 9.6 mm
Initial Base Curve:
Flat K 42.75D 7.90mm
+ Corneal Astigmatism Fa c t o r 0 . 5 0 D steeper than Flat K
= Initial Base Curve 43.25D
Base Curve Radius 43.25D 7.80 mm
You may use the above method to select your initial base curve or you may refer to the chart below:
Note: Corneal astigmatism greater than 1.50D should be evaluated with a 0.1 mm steeper lens. Greater than
2.50D of corneal astigmatism may require a 0.2 mm steeper lens.
Determine Flat K Select Base Curve
Range (diopters) Corneal Corneal
40.00 - 40.25 – 8.3
40.50 - 40.75 8.3 8.2
41.00 - 41.25 8.2 8.1
41.50 - 41.75 8.1 8.0
42.00 - 42.25 8.0 7.9
42.50 - 42.75 7.9 7.8
43.00 - 43.50 7.8 7.7
43.75 - 44.00 7.7 7.6
44.25 - 44.50 7.6 7.5
44.75 - 45.25 7.5 7.4
45.50 - 45.75 7.4 7.3
46.00 - 46.50 7.3 –
Recommendation (mm)
Astigmatism Astigmatism
<
1.50D > 1.50D
With this initial base curve selection evaluate the following:
A. Lens Movement:
The lens MUST move freely with the blink. Poor translation will not place the reading portion of the lens in front
of the pupillary zone upon down gaze. If the lens does not translate well, try a flatter base curve. The greatest
effect of the add is achieved when the lens interacts with the lo wer lid in down gaze which will facilitate upwa r d
t ra n s l a t i o n .
B. Lens Centration:
The lens should center over the pupil in primary gaze and translate upward in down gaze.The greatest effect of
the add is achieved when the lens interacts with the lower lid in down gaze which will facilitate upward translation.If the lens is not well centered over the pupil in primary gaze (straight ahead) try a steeper base curve.
C. Fluorescein Pattern:
In evaluating the fluorescein pattern, divide the pattern into three zones: central, intermediate and peripheral.
The ideal fluorescein pattern is one that demonstrates an aligned to slightly bearing central zone, an aligned
intermediate zone and a peripheral zone that demonstrates a slightly high edge. This slightly high edge lift or flu
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