Bausch & Lomb SofLens Multi-Focal Contact Lenses - Manual (Page 3)

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.
• 3 or 4 days post-dispensing
• 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.
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.
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.
professIonal 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.
MUltI-focal fIttInG GUIDelInes
1. Patient Selection
a. Corneal astigmatism: Up to –0.75 x 180, up to -0.75 x 90
b. Habitual distance Rx (greater than + 0.75D)
c. Good motivation
d. Realistic expectations
2. Lens Selection
a. Choose 8.5 base curve for 43.75D and steeper and 8.8 base curve for 43.50D
and flatter.
b. Select the patient’s distance spectacle sphere (must be in minus cylinder form,
ignore the cylinder) and vertex, if necessary.
c. Select the appropriate ADD.
• Bausch + Lomb SofLens ® Multi-Focal Low ADD: +0.75 to +1.50D.
• Bausch + Lomb SofLens ® Multi-Focal High ADD: +1.75 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. Excessive Movement—to achieve stability and proper centration, steepen
base curve to 8.5mm.
b. Decentration—steepen base curve to 8.5mm.
c. Acuity—0.25D makes a significant difference in acuity, re-check near and
distance acuities with over-refraction in place.
d. 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.
e. 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 bifocal
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 SofLens ® Multi-
Focal (polymacon) Visibility Tinted Contact Lenses.
Occupational and environmental visual demands should be considered.
If the patient requires critical vision (visual acuity and stereopsis) it should
be determined by trial whether this patient can function adequately with
monovision. Monovision contact lens wear may not be optimal for such
activities as:
(1) visually demanding situations such as operating potentially dangerous
machinery or performing other potentially hazardous activities; and
(2) driving automobiles (e.g., driving at night). Patients who cannot pass their
state drivers license requirements with monovision correction should be
advised to not drive with this correction, OR may require that additional
over-correction be prescribed.
b. Patient Education
All patients do not function equally well with monovision correction.
Patients may not perform as well for certain tasks with this correction as
they have with bifocal 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
Generally, the non-dominant eye is corrected for near vision. The following test for eye
dominance can be used.
a. Ocular Preference Determination Methods
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 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 then graduate to
newsprint and finally smaller type sizes.
After the patient’s performance under the above conditions are completed, tests of
visual acuity and reading ability under conditions of moderately dim illumination should
be attempted.
An initial unfavorable response in the office, while indicative of a guarded prognosis,
should not immediately rule out a more extensive trial under the usual conditions in
which a patient functions.
6. Adaptation
Visually demanding situations should be avoided during the initial wearing period.
A patient may at first experience some mild blurred vision, dizziness, headaches,
and a feeling of slight imbalance. You should explain the adaptational symptoms
to the patient. These symptoms may last for a brief minute or for several weeks.
The longer these symptoms persist, the poorer the prognosis for successful
adaptation.
To help in the adaptation process the patient can be advised to first use the lenses
in a comfortable familiar environment such as in the home.
Some patients feel that automobile driving performance may not be optimal
during the adaptation process. This is particularly true when driving at night.
Before driving a motor vehicle, it may be recommended that the patient be
a passenger first to make sure that their vision is satisfactory for operating an
automobile. During the first several weeks of wear (when adaptation is occurring),
it may be advisable for the patient to only drive during optimal driving conditions.
After adaptation and success with these activities, the patient should be able to
drive under other conditions with caution.
7. Other Suggestions
The success of the monovision technique may be further improved by having your
patient follow the suggestions below.
• Having a third contact lens (distance power) to use when critical distance
viewing is needed.
• Having a third contact lens (near power) to use when critical near viewing is
needed.
• Having supplemental spectacles to wear over the monovision contact lenses
for specific visual tasks may improve the success of monovision correction.
This is particularly applicable for those patients who cannot meet state
licensing requirements with a monovision correction.
• Make use of proper illumination when carrying out visual tasks.
Success in fitting monovision can be improved by the following suggestions:
• Reverse the distance and near eyes if a patient is having trouble adapting.
• Refine the lens powers if there is trouble with adaptation. Accurate lens power
is critical for presbyopic patients.
• Emphasize the benefits of the clear near vision in straight ahead and upward
gaze with monovision.
* The decision to fit a patient with a monovision correction is most
appropriately left to the eye care professional in conjunction with the
patient after carefully considering the patient’s needs.
* All patients should be supplied with a copy of the
SofLens ® Multi-Focal 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 and Disposable Wear
For complete information concerning the care, cleaning and disinfection of contact
lenses refer to the SofLens ® Multi-Focal (polymacon) Visibility Tinted Contact Lens
Patient Information Booklet.
Disposable Wear
For complete information concerning emergency lens care, refer to the SofLens
®
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.
care for a DrIeD oUt
(DeHyDrateD) lens
If a soft, hydrophilic contact lens is exposed to air while off the eye, it may become dry
and brittle and need to be rehydrated. If the lens is adhering to a surface, apply the
recommended rinsing solution before handling.
To rehydrate the lens:
• Handle the lens carefully.
• Place the lens in its storage case and soak the lens in a recommended rinsing and
storing solution for at least 1 hour until it returns to a soft state.
• Clean lens first, then disinfect the rehydrated lens using a recommended lens care
system.
• If after soaking, the lens does not become soft, if the surface remains dry, DO
NOT USE THE LENS UNTIL IT HAS BEEN EXAMINED BY YOUR EYE
CARE PROFESSIONAL.
eMerGencIes
If chemicals of any kind (household products, gardening solutions, laboratory
chemicals, etc.) are splashed into your eyes, you should: FLUSH EYES
IMMEDIATELY WITH TAP WATER AND THEN REMOVE LENSES PROMPTLY.
CONTACT YOUR EYE CARE PROFESSIONAL OR VISIT A HOSPITAL
EMERGENCY ROOM WITHOUT DELAY.
reportInG of aDVerse reactIons
All serious adverse experiences and adverse reactions observed in patients
wearing Bausch + Lomb SofLens ® Multi-Focal (polymacon) 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 a phosphate
buffered saline solution with 0.1% polyvinyl alcohol. The container is marked with
the manufacturing lot number of the lens, the base curve, sphere power, add
power, diameter and expiration date.
18 17 16 15
22
26
21
25
20
24
19
23