Toric (alphafilcon A)
For Astigmatism
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.
TABLE OF CONTENTS |
Page |
Introduction |
2 |
Description |
2 |
Lens Parameters Available |
3 |
How the Lens Works (Actions) |
4 |
Indications |
4 |
Contraindications (Reasons Not To Use) |
4 |
Warnings |
5 |
Precautions |
6 |
Adverse Reactions |
8 |
Important Treatment Information for Adverse Reactions |
8 |
Selection of Patients |
9 |
Fitting Procedure |
9 |
Pre-fitting Examination |
9 |
Initial Lens Power Selection |
9 |
Initial Lens Evaluation |
10 |
Criteria of a Well-Fitted Lens |
11 |
Characteristics of a Tight (Steep) Lens |
11 |
Characteristics of a Loose (Flat) Lens |
11 |
Follow-up Care |
11 |
Professional Fitting Sets |
12 |
Wearing Schedule |
12 |
Monovision Fitting Guidelines |
12 |
Patient Selection |
12 |
Eye Selection |
13 |
Special Fitting Considerations |
13 |
Near Add Determination |
14 |
Trial Lens Fitting |
14 |
Adaptation |
14 |
Other Suggestions |
15 |
Handling of Lens |
15 |
Patient Lens Care Directions |
15 |
Frequent Replacement and Disposable Wear |
15 |
Care for a Sticking (Nonmoving) Lens |
15 |
Reporting of Adverse Reactions |
16 |
How Supplied |
16 |
Symbol Reference Guide |
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Introduction
This package insert and fitting guide has been developed to provide eye care professionals with information covering characteristics of the BAUSCH & LOMB SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lens with the Lo-Torque® design and to illustrate fitting procedures. It is effective as of January 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 SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lens with the Lo-Torque® design is a flexible shell with toric surfaces. The lens is made from a copolymer of 2-hydroxyethyl methacrylate, N-vinyl pyrrolidone and 4-tertiary butyl-2-hydroxycyclohexyl methacrylate, and is 66% water by weight when immersed in a sterile solution of sodium chloride and a borate buffer. This lens is tinted blue with up to 100 ppm of Reactive Blue Dye 246.
The physical/optical properties of the lens are:
Specific Gravity: |
1.075 |
Refractive Index: |
1.390 |
Light Transmittance |
|
Tinted: |
C.I.E. value—approximately 99% |
Water Content: |
66% |
Oxygen Permeability: |
32 x 10–11[cm3O2(STP) x cm]/(sec x cm2 x mmHg) @ 35° C |
|
(Polarographic Method) |
The SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses are tinted blue using Reactive Blue 246 (1,4-bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone) to make the lens more visible for handling purposes. The apparent color of the SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses may decrease slightly following repeated disinfection. This will not affect the safety or performance of the lens.
The BAUSCH & LOMB SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lens is manufactured using the FormCast™ manufacturing process. The anterior surface of the lens contains the spherical power, prism ballast and comfort chamfer feature of the SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lens. The posterior surface is manufactured with a spherocylindrical curve to accommodate the required astigmatic power.
Prism ballasting stabilizing geometry—increased thickness from apex to base of lens offers excellent axis stabilization
Refined aspheric optic zone—anterior and posterior optic zone diameters are adjusted to minimize
variations in thickness providing optimal stability
360° comfort chamfer—reduces lens mass for
rotational stability
Balanced vertical thickness profile—uniform
mid-peripheral thickness at apex, center, and base of optic zone enhances rotational stability
Unique bicurve posterior design for optimum centration and visual acuity
Rounded edges—provide comfort plus optimal movement over conjunctival tissue
Guide Mark System
Each BAUSCH & LOMB SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lens is marked with 3 Guide Marks in the lens perimeter, 30 degrees apart at 5, 6, and 7 o’clock. These Guide Marks give an instant reference for estimating lens rotation and orientation. They are, in effect, a protractor guide on the lens surface. All guide markings make proper axis orientation and fitting faster and easier. The center guide mark need not position at 6 o’clock on the cornea.
Diameter |
Guide Markings |
14.5mm |
|
30˚ |
30˚ |
|
(6 o’clock) Center Guide |
LENS PARAMETERS AVAILABLE
The BAUSCH & LOMB SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
Diameter: |
14.5mm |
Center Thickness: |
0.190mm @ -3.00D (varies with power) |
Base Curve: |
8.5mm |
Sphere Powers: |
+6.00 to -6.00D in 0.25D steps |
|
-6.50D to -9.00D in 0.50D steps |
Cylinder Powers: |
-0.75D, -1.25D, -1.75D, -2.25D and –2.75D |
Axis: |
0° to 180° in 10° Increments |
Lens Prism: |
Prism is located at the base of the lens to stabilize lens positioning when the |
|
lens is on eye. |
Comfort Chamfer: |
A wedge-shaped tapered section on the anterior surface of the lens from the |
|
3 to 9 o’clock areas. This reduces lens thickness. |
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HOW THE LENS WORKS (ACTIONS)
In its hydrated state, the BAUSCH & LOMB SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lens has a unique Lo-Torque® design that results in excellent stability and when placed on the cornea acts as a refracting medium to focus light rays on the retina.
INDICATIONS
The BAUSCH & LOMB SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lens is indicated for daily wear or extended wear from 1 to 7 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) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 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 -9.00D when prescribed for up to 7 days of extended wear and from +20.00D to –20.00D for daily wear.
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 SofLens® Toric (alphafilcon 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 SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lens is to be discarded after each removal.
CONTRAINDICATIONS (REASONS NOT TO USE)
DO NOT USE the BAUSCH & LOMB SofLens® Toric (alphafilcon 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 SofLens® Toric (alphafilcon A) Visibility Tinted 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 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.
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 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.
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 value for the commonly prescribed spherical powers of the toric lenses is lower than the high minus spherical powers. As the cylinder power increases the oxygen transmissibility decreases. Overall, the toric lens has oxygen transmissibility values that are from 10% to 50% lower than the value of the spherical lenses in the alphafilcon A material.
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.
•Eye care professionals should instruct the patient to REMOVE A LENS IMMEDIATELY if an eye becomes red or irritated.
•Fluorescein should not be used while the patient is wearing the lenses, because the lenses will become discolored. Whenever fluorescein is used, flush the eyes with sterile saline solution. Wait at least 5 minutes before reinserting the lenses. If it is not possible to flush the eyes, wait a minimum of 1 hour before reinserting the lenses. If replaced too soon, the lenses may absorb residual fluorescein.
•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 extended wear even if able to tolerate the same or another lens on a daily wear basis. Some patients who are able to tolerate extended wear will not be able to wear their lenses continuously for 7 days. Patients should be carefully evaluated for extended wear prior to prescription and dispensing, and eye care professionals should conduct early and frequent follow-up examination to determine ocular response to extended 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.
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.
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