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«PROFESSIONAL FITTING GUIDE FOR THE CLARITY H2O® (hioxifilcon D) Soft Contact Lens for Daily Wear CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ...»

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Hydrogel Vision Corporation Quality Systems & Quality Assurance Manual

Document Title: Fitting Guide – Clarity H2O

Revision Level: 1 Document ID: QCFQ-032

Revision Date: 1/2010 Page 1

PROFESSIONAL FITTING GUIDE

FOR THE

CLARITY H2O®

(hioxifilcon D) Soft Contact Lens for Daily Wear

CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER

OF

A LICENSED PRACTITIONER

Please read this guide carefully and follow the instruction so that you receive full satisfaction from your lenses.

DESCRIPTION OF LENS

Clarity H2O® (hioxifilcon D) soft contact lenses are hemispherical shells and are available as spherical lenses of the following dimensions:

Clarity H2O Flat Clarity H2O Median Clarity H2O Steep Parameters Values Parameters Values Parameters Values Diameter: 14.0mm Diameter: 14.0mm Diameter: 14.0mm Center Thickness: 0.085mm @ -3.00 Center Thickness: 0.085mm @ -3.00 Center Thickness: 0.085 @ -3.00 varies with power varies with power varies with power Base Curve: Flat (equiv. to 8.7) Base Curve: Med (equiv. to 8.4) Base Curve: Steep (equiv. to 8.1) Power Range: -0.25 to -6.00 Power Range: +6.00 to -6.00 Sphere Power: -0.25 to -6.00 by 0.25 diopters by 0.25 diopters by 0.25 diopters

-6.50 to -10.00 -6.50 to -10.00 by 0.50 diopters by 0.50 diopters The Clarity H2O® (hioxifilcon D) soft contact lens is fabricated from hioxifilcon D, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilcon D and 54% water by weight when immersed in normal saline solution buffered with either sodium bicarbonate or sodium perforate. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper).

–  –  –

ACTIONS In its hydrated state, the Clarity H2O® (hioxifilcon D) soft contact lens, when placed on the cornea, acts as a refracting medium to focus light rays on the retina. The toric lens provides a more even surface over the highly uneven astigmatic cornea and thus helps to focus light rays on the retina.

CAUTION 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 were not evaluated in significant numbers. Consequently, when selecting an appropriate lens design and parameters, the eye care practitioner 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 potential impact of these factors on the patient's ocular health must 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 eye care practitioner.

INDICATIONS

The ClarityH2O® (hioxifilcon D) spherical soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or notaphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement.

When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

CONTRAINDICATIONS:

DO NOT USE the Clarity H2O® (hioxifilcon D) soft contact lenses when any of the following conditions are present:

 Acute or subacute inflammation or infection of the anterior chamber of the eye.

 Any eye disease, injury, or abnormality that affects the cornea, conjunctive, or eyelids.

 Severe insufficiency of lacrimal secretion (dry eyes).

 Corneal hypoesthesia (reduced corneal sensitivity), if not-aphakic.

 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 use of contact lens solutions.

 Allergy to any ingredient, such as mercury or thimerosal, in solution which must be used to care for Clarity H2O® soft contact lenses.

 Any active corneal infection (bacterial, fungi, or viral).

 If eyes become red or irritated.

 Patients unable to follow lens care regimen or unable to obtain assistance to do so.

WARNINGS

Patients should be advised of the following warnings pertaining to contact lens wear:

PROBLEMS WITH CONTACT LENSES AND CONTACT LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It

is essential that you follow your eye care practitioner's directions and all labeling instructions for proper use of your lenses and lens care products, including the lens case. EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP RAPIDLY AND LEAD TO LOSS OF





VISION; THEREFORE, IF YOU EXPERIENCE ANY DISCOMFORT, EXCESSIVE TEARING, VISION CHANGES, REDNESS OF THE EYE,

IMMEDIATELY REMOVE YOUR LENSES AND PROMPTLY CONTACT YOUR EYE CARE PRACTITIONER.

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 these lenses are worn overnight.

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 lens and promptly contact his or her eye care practitioner.

ALL CONTACT LENS WEARERS MUST RETURN FOR PERIODIC CHECK-UP VISITS AS RECOMMENDED BY THEIR EYE CARE

PRACTITIONER.

FITTING PROCEDURE (SPHERICAL)

Patient Selection The practitioner should first assess the patient’s needs and characteristics necessary to fit with Clarity H2O® lenses. A through pre-fitting examination should be conducted to ensure the patient is a suitable candidate for soft contact lens wear.

Pre-fitting Examination

A pre-fitting examination is necessary to:

 Determine if the patient is a suitable candidate in terms of motivation, physical state, and willingness to comply with instructions concerning wear time and hygiene;

 Carefully evaluate the lids, lashes, conjunctival areas as well as the anterior segment of the eye for suitability for contact lens wear;

 Take 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 a case history, a spherocylindrical refraction, keratometric readings, tear assessment, and biomicroscopy of the anterior segment.

–  –  –

The initial power selection should be as close as possible to the patient’s prescription after taking into account spherical equivalent and vertex calculations, if necessary. Remember to compensate for vertex distance if the refraction is greater than ± 4.00D.

Base Curve Selection A well-fitted lens provides good movement, centration, and comfort. This can be achieved for the majority of patients with the 8.4 mm base curve.

However, corneal curvature measurements should be performed to establish the patient’s baseline ocular status.

Place a lens on each of the patient’s eyes and allow a 15 minute period of adjustment and equilibration.

Characteristics of a Well-Fitted Lens: A properly fitted lens will center and completely cover the cornea in all fields of gaze, allow sufficient lens movement to provide tear exchange under the lens during a blink in primary or upgaze, move freely when manipulated with the index finger on the lower lid nudging upward, and return to its properly centered position when released.

Characteristics of a Tight (Steep) Lens: A tight or steep fit may provide insufficient or no lens movement during a blink in primary or upgaze, resist movement if nudged upward with the index finger and/or cause fluctuating vision between blinks. If the contact lens is deemed to be steep fitting, do not dispense to the patient. A flatter lens (larger base curve) should be evaluated if available.

Characteristics of a Loose (Flat) Lens: A loose or flat fit may exhibit reduced comfort, decentration, excessive movement during the blink or in primary upgaze, and/or edge standoff. If the contact lens is deemed to be flat fitting, do not dispense to the patient. A steeper lens (smaller base curve) should be evaluated if available.

Final Lens Power Determination After the lens fit is successful, a spherical over-refraction should be performed to determine the proper lens power to be dispensed.

Example: Diagnostic lens: -3.00D Over-refraction: -0.25D Final lens power: -3.25D

FOLLOW-UP EXAMINATIONS

 Within one week of lens dispensing  After three weeks of lens wear  After seven weeks of lens wear  After each six-month period of lens wear.

At the follow-up examinations, the patient should report good subjective quality of vision. Adaptation to vision with Clarity H2O® (hioxifilcon

D) soft contact lenses should occur almost immediately and should definitely be reported within the first (1 week) follow-up visit. At these

follow-up visits the practitioner should:

 Check distances and near acuity with lenses in place.

 Over-refract to verify lens prescription.

 Observe the position of the lens on the cornea. The lens should be centered and move on upward gaze and with a blink.

 Evert the lids to examine the tarsal conjunctiva and check for incidence of giant papillary conjunctivitis.

 Remove the lens. Check corneal curvature. There should be no substantial changes in either meridian.

 Perform a slit-lamp examination with and without Fluorescein. Check for corneal edema, corneal abrasion, vascularization, corneal infiltrates, and perilimbal injection. Reinsert the lens only after all residual Fluorescein has dissipated from the eye.

 Clean the lens with a surfactant cleaner, and examine for deposits, foreign bodies or physical imperfections of the lens surface.

LENS HANDLING

Wash and rinse hands thoroughly, making certain all soap residues have been rinsed away before drying with a lint-free towel. It is suggested to wet the lens while in the eye using lubricating and rewetting drops before removal of the lens. Care should be used not to pinch the lens when removing it from the eye. Pinching the lens can reduce the life of the lens.

Always start with the right lens first in order to avoid mixing the lenses. In removing the lenses, try to avoid touching the inside (concave) surface of the lens. It is possible, though not likely, that the lens might be inside out; therefore, check the lens by placing it on the index finger and examine its profile. If the edges of the lens tend to point outward, the lens is inside out. After removing the lens from its container assure that it is clean, clear and wet.

CLEANING & RINSING Based on practitioner recommendation, a surfactant cleaner can be used with Clarity H2O hioxifilcon D soft contact lenses to ensure a clean lens surface. Follow the recommendations of the manufacturer of the cleaning solution. Thoroughly rinse both surfaces of the lens with a steady stream of rinsing solution.

CHEMICAL (NOT-HEAT) LENS CARE SYSTEM

A sterile rinsing, storing, and disinfecting solution should be used to rinse and chemically disinfect Clarity H2O® (hioxifilcon D) soft contact lenses.

After cleaning the lens, rinse with a liberal amount of fresh rinsing solution to remove loosened debris and traces of cleaner. The lens should then be placed in an appropriate lens storage case and filled with enough fresh disinfecting solution to completely submerge the lens. To ensure disinfecting, the lens must remain in the disinfecting solution for the period of time recommended in the disinfecting solution instructions for use. Before reinsertion, lenses should be rinsed with fresh sterile rinsing solution.

LENS CARE DIRECTIONS

Refer to Package Insert.

–  –  –

The Clarity H2O® (hioxifilcon D) soft contact lenses must be stored in the recommended solutions. If exposed to the air, the lenses will dehydrate. If a lens dehydrates, it should be soaked ONLY in a soft contact lens storage solution until it returns to a soft, supple state. It should not be put on an eye until it has been put through a complete disinfecting cycle and a thorough inspection.

LENS CARE PRODUCTS

The eye care practitioner should recommend a care system that is appropriate for hydrophilic soft contact lenses. Each lens care product contains specific directions for use and important safety information, which should be read and carefully followed.

RECOMMENDED WEARING SCHEDULE



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