Bausch & Lomb NEW Bausch + Lomb ULTRA contact lenses User Manual

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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 prefitting examination should include spherocylinder refraction and VA,

keratometry, and biomicroscopic examination.
2. Initial Lens Power Selection
• Lens power is determined from the patient’s spherical equivalent prescription

corrected to the corneal plane. Select the appropriate lens and place on the

eye.

• Allow the lens to remain on the eye long enough (10 to 20 minutes) to achieve a

state of equilibrium. Small variations in the tonicity, pH of the lens solutions, and

individual tear composition may cause slight changes in fitting characteristics.

• Allow any increase in tear flow to subside before evaluating the lens. The time

required will vary with the individual.

3. Initial Lens Evaluation
a. To determine proper lens parameters, observe the lens relationship to the eye

using a slit lamp.

• Movement: The lens should provide discernible movement with:

— Primary gaze blink
— Upgaze blink
— Upgaze lag

• Centration: The lens should provide full corneal coverage.

b. Lens evaluation allows the contact lens fitter to evaluate the lens/cornea

relationship in the same manner as would be done with any soft lens. If after

the lens has settled on the eye, the patient reports lens sensation, or if the

lens is moving or decentering excessively, the lens should not be dispensed.

Alternatively, if the patient reports variable vision, or if the lens shows insufficient

movement, the lens should not be dispensed.

4. Criteria of a Well-Fitted Lens
If the initial lens selection fully covers the cornea, provides discernible movement

after a blink, is comfortable for the patient and provides satisfactory visual

performance, it is a well fitted lens and can be dispensed.

5. Characteristics of a Tight (Steep) Lens
A lens which is much too steep may subjectively and objectively cause distortion

which will vary after a blink. However, if a lens is only marginally steep, the initial

subjective and objective vision and comfort findings may be quite good. A

marginally steep lens may be differentiated from a properly fitted lens by having

the patient gaze upward. A properly fitted lens will tend to slide downward

approximately 0.5mm while a steep lens will remain relatively stable in relationship

to the cornea, particularly with the blink.
6. Characteristics of a Loose (Flat) Lens
If the lens is too flat, it will:
• Decenter, especially on post-blink.
• Have a tendency to edge lift inferiorly and sit on the lower lid, rather than

positioning between the sclera and palpebral conjunctiva.

• Have a tendency to be uncomfortable and irritating with fluctuating vision.
• Have a tendency to drop or lag greater than 2.0mm on upgaze post-blink.

7. Follow-up Care
a. Follow-up examinations are necessary to ensure continued successful contact

lens wear. From the day of dispensing, the following schedule is a suggested

guideline for follow up.

• 24 hours
• 10 days
• 1 month
• 3 months
• 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.

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.
Disposable Lens Wear
No lens care is needed. The lenses are discarded every time they are removed from

the eye. Lenses should only be cleaned, rinsed and disinfected on an emergency

basis when replacement lenses are not available.
Frequent/Planned Replacement
When removed between replacement periods, lenses must be cleaned and

disinfected before reinsertion, or be discarded and replaced with a new lens.

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 Ultra (samfilcon A)

Visibility Tinted Soft (hydrophilic) 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 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 is 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 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 Bausch + Lomb Ultra

(samfilcon A) Visibility Tinted Soft (hydrophilic) 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 Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens

Frequent/Planned Replacement Wear Patient Instruction Booklet.
disposable Wear: For complete information concerning emergency lens

care, refer to the Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft

(hydrophilic) Contact Lens Patient Information Booklet.

CARe fOR A sTICKING

(NONMOVING) leNs

If the lens sticks (stops moving), the patient should be instructed to use a lubricating

or rewetting solution in their eye. The patient should be instructed to not use plain

water, or anything other than the recommended solutions. The patient should be

instructed to contact the eye care professional if the lens does not begin to move

upon blinking after several applications of the solution, and to not attempt to remove

the lens except on the advice of the eye care professional.

RePORTING Of AdVeRse ReACTIONs

All serious adverse experiences and adverse reactions observed in patients wearing

Bausch + Lomb

Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact

Lenses or experienced with the lenses should be reported to:
Bausch & Lomb Incorporated

1400 North Goodman Street

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 with poloxamine solution. The container is marked with the manufacturing lot

number of the lens, the base curve, sphere, diameter and expiration date.