INTACS

INTACS are very thin plastic prescription inserts for the correction of mild
nearsightedness (myopia), a condition that affects over 20 million adult
Americans. In contrast to other surgical procedures for reshaping the cornea
of the eye, Intacs reshape the curvature of the cornea by the placing within
the rim of the cornea two clear prescription inserts made of a plastic, called
polymethylmethacrylate or PMMA. PMMA is very well tolerated by the body
(biocompatible) and has been used in contact lenses and cataract surgery
for over 50 years. They can be removed or replaced if vision needs to be
changed.

Anatomy and Physiology

There are two eyes. The eyes lie in bony casings within the skull called
orbits. Each eye is globular in shape and about one inch in diameter. Light
entering the front of the eye passes through the cornea, anterior (front)
chamber, iris, lens and vitreous and finally is focused on the retina, the film
of the eye. (Figures 1 and 2)

Figure 1 - Cross-sectional anatomy of the eye. See text for descriptions.

Figure 2 - Normal eye. An object is focused on the retina.

The cornea is a curved, highly transparent tissue that separates air

from clear fluid in the anterior chamber of the eye, which lies
between the cornea and lens. The cornea is approximately 0.5 mm.
thick. It is comparable in size to a contact lens
The lens is a firm gel-like transparent tissue that is almost eight
millimeters (one-third inch) in diameter and biconvex in shape, that
is, thicker in the center than at the edge. A thin transparent capsule
surrounds the lens
The iris is in front of the lens and consists of a circular pigmented
muscle that gives the eye its color. The iris acts like the diaphragm
of a camera and adjusts the amount of light that enters the eye
through the hole in its center called the pupil. Light then passes
through the vitreous, a clear gel-like material that fills the center of
the eye, onto the retina
The retina is the film of the eye. It is a true extension of the brain
and is composed of special nerve cells sensitive to light
The optic nerve is formed from these nerve cells and carries the
light image entering the eye to the brain

In the normal eye with perfect vision, the light rays enter the eye and are
focused precisely on the retina. In this situation, a clear image is sent to the
brain. The cornea provides about 75 percent of the eye's focusing or
refractive power. The natural lens inside the eye provides the remaining
focusing power. The shape, or curvature, of the cornea determines how well
you see and how "in focus" an image is when it reaches the retina. Nearly
all of the light that reaches the retina must pass through the central area of
the cornea or the "optical zone".

Pathology
While some people with mild nearsightedness can function without their

glasses or contact lenses in certain situations, most rely on corrective

lenses everyday. In the United States, INTACS inserts are indicated for the
correction of mild nearsightedness.

Nearsightedness occurs when the cornea has a steeper curve than

normal or the length of the eyeball from front to back is too long. In
either situation distant light entering the eye focuses in front of the
retina. (Figure 3)

Figure 3 - Nearsighted eye. A distant object is focused in front of

the retina causing a blurred image.

People with nearsightedness see nearby objects clearly, but distant

objects appear blurry
The degree of nearsightedness is measured in negative (-) diopters.
INTACS are available for the correction of -1.00 to -3.00 diopters of
nearsightedness in persons who have no more than 1 diopter of
astigmatism. (Astigmatism is a condition in which the curvature of
the eye is irregular. This irregularity causes the light rays entering
the eye to come to different points of focus. The result is blurred
vision.)

History and Examination

A general eye exam is necessary. The ophthalmologist (eye

specialist) will also need information about your overall health and
medical history. The following tests are typically conducted to
determine if a patient is a good candidate for any refractive surgery,
including INTACS inserts:
General history. This allows the physician to determine if refractive
surgery is an option. Questions include general medical history,
ophthalmic history and current medications
Dilated exam (Ophthalmoscopy). The patient's eyes are dilated with
drops placed in the eye (cycloplegic) and the ophthalmologist
examines the vitreous and retina. The patient is asked to look at a

point in the room, and the doctor shines a bright light in the eye
Manifest and Cycloplegic Refraction. This measures the patient's
prescription for eyeglasses. The manifest refraction is completed
first and the cycloplegic refraction is completed after the use of eye
drops to dilate the pupil
Slit Lamp Exam. A slit lamp is a special type of microscope. The
ophthalmologist is able to examine the cornea and also determine if
the tear film is adequate. Additionally, the doctor exams the eyelids
to assure they are free of any infections that may compromise the
surgical outcome
Keratometry. The curvature (shape) of the cornea is measured
Tonometry. The intraocular (inside the eye) pressure of the eye is
measured. This is particularly important in patients with glaucoma in
which the intraocular pressure is above normal
Topography. This "maps" the cornea to give more precise
information about its curvature and surface
Visual Acuity Testing. Uncorrected and best-corrected (with lenses)
vision is tested using standard eye charts

Important: If you wear contact lenses, it is very important to stop wearing

them 2-3 weeks before your preoperative examination per your doctor's
instructions. Failure to do this may produce poor results.

Indications and Contraindications

Candidates for the inserts must

1. Be at least 21 years of age
2. Have healthy eyes that are free from disease or corneal
abnormality (for example: scarring or infection)
3. Have nearsightedness between -1.00 to -3.00 diopters with
no more than 1.00 diopter of astigmatism
4. Have documented evidence of stable vision for at least one
year (minor fluctuations may not disqualify candidate)
You should NOT have the inserts placed if
1. You have autoimmune or immunodeficiency diseases (for
example: lupus, rheumatoid arthritis, AIDS)
2. You are pregnant or nursing
3. You have known conditions of the eye that may increase the
likelihood of future problems
4. You are taking prescription medications, such as isotretinoin
(Accutane ); amiodarone (Cordarone ); sumatriptan
(Imitrex ) that may affect corneal healing or your vision. You
should discuss all medications you take, even over-thecounter medications, with your eye doctor
Discuss with your doctor if
1. You have insulin-dependent diabetes or other medical
conditions that affect wound healing
2. You have had a Herpes infection in your eyes
3. Intacs do NOT eliminate the need for reading glasses. The
need for reading glasses is caused by a natural condition of
aging called presbyopia. Between ages 40 and 50, the lens
of the eye loses its ability to focus on objects at close range.
This is when many people begin to rely on reading glasses.
No refractive surgery currently available can prevent the

changes that cause presbyopia or correct this condition.

However, because Intacs can be removed or replaced, they
may provide other options as vision changes occur with
age.

Surgical Procedure

INTACS are inserted in a brief outpatient procedure by an

ophthalmologist. They cannot be felt, are no more visible than a
contact lens and require no maintenance. Because the optical zone
is crucial for clear vision, the inserts are designed to be placed at
the outer edge of the cornea and away from the optical zone. The
inserts are placed in the periphery of the cornea and reshape the
cornea by flattening it just enough to allow light rays entering the
eye to focus on the retina
The procedure usually takes only 15 minutes per eye but plan on at
least an hour for the visit. Typically, a mild oral sedative will be given
before the procedure. You will be positioned comfortably, facing up,
on a surgical table or reclining chair. Your face will be covered with a
surgical drape exposing only the surgery eye. Anesthetic drops are
used to numb the eye, which is held open throughout the procedure
to prevent blinking
1. A single, small opening is made in the cornea (Figure 4)
2. To stabilize the eye, a centering guide is placed on the
surface of the cornea for one to two minutes. Patients may
experience some discomfort (typically a pressure sensation)
during this part of the procedure (Figure 5)
3. The cornea has several layers to it, like a pad of paper.
These layers are called the stroma. Making a place for the
Intacs within the stroma is like separating two pages just
enough to create a space. While the eye is stabilized, two
semicircular tunnels are made in the cornea. The INTACS
inserts are placed in these tunnels. The inserts are placed
within the layers of the cornea at approximately a two-thirds
depth (Figure 6)
4. After the second INTACS segment is placed, the small
opening in the cornea is closed

Figure 4 - A small incision is made in the outer

layer of the cornea. Courtesy KeraVision, Inc

Figure 5 - The eye is stabilized with centering

guide. Courtesy KeraVision, Inc

Figure 6 - Two INTACS segments are placed within

the intrastromal tunnels. Courtesy Keravision, Inc

Complications

Infection- this occurred in 0.2% of patients

Shallow placement of the INTACS inserts has occurred in 0.2% of
patients
Temporary loss of 2 lines of best corrected vision occurs in 0.2% of
patients
Anterior chamber perforation during placement of the INTACS has
occurred in 0.4% of patients
Overcorrection of nearsightedness
Undercorrection
Reduction in sensation of the central portion of the cornea
Difficulty with night vision

Irregularity of the cornea causing astigmatism

Blurred vision
Double vision
Corneal blood vessels
Halos of light
Glare
Fluctuating distance vision

If the results of the procedure are not satisfactory, Intacs can be removed or
replaced. In the small number of cases where Intacs were removed,
patients' vision returned to levels seen before surgery by 3 months following
removal, in most cases. All patients were able to be corrected with glasses
to 20/20 or better following the removal of the inserts.

Care after Surgery

Antibiotic eye drops may be prescribed. Your doctor may prescribe

steroid drops for the first week or two following the procedure to
decrease any irritation and redness. All medicines should be taken
as directed
To prevent accidental rubbing of the eyes during sleep, the patient
may be instructed to wear a clear shield at night in the first few
weeks after surgery
Eyes are examined the day following the procedure. If there are no
complications, a typical follow-up schedule is one week, one month,
three months, six months and one year
Most patients see an improvement in vision the day after surgery,
though vision may fluctuate during the initial healing process
In clinical studies, 97% of patients saw 20/40 or better with INTACS;
74% saw 20/20 or better-the standard for good vision, and 53% saw
20/16 or better-a level that exceeds the standard for good
vision(Figure 7)

Figure 7 - Nearsighted vision as corrected with inserted INTACS

segments. Courtesy KeraVision, Inc
INTACS is a registered trademarks of KeraVision,Inc Accutane is a registered trademark of Roche
Pharmaceuticals. Cordarone is a registered trademark of Wyeth-Ayerst Laboratories. Imitrex is a
registered trademark of Glaxo-Wellcome, Inc.
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