What You Need To Know
About Cataracts And
Cataract Surgery
A cataract is a cloudy area in the
normally clear lens of your eye, causing
blurry vision. Most cataracts are related
to aging and, over time, can lead to
vision loss. When a cataract interferes
with your usual activities, such as
reading and driving, your physician will
likely recommend cataract surgery.
During cataract surgery, your lens is
removed and replaced with a clear
artificial lens. This lens is called an
intraocular lens (IOL). Cataract surgery
is the most common procedure in the
world and is one of the safest and most
successful procedures performed today.
Cataract surgery can also offer the
opportunity to correct other vision
problems you may be experiencing
such as myopia (nearsightedness),
hyperopia (farsightedness),
astigmatism (irregularly shaped lens),
or presbyopia (diminishing ability to
focus with age).
The First And Only IOL
Adjustable After
Cataract Surgery—The
Light Adjustable Lens™
Despite numerous advances in modern
cataract surgery technologies, many
patients continue to be disappointed
with their vision outcomes. That is
why RxSight developed the first IOL
that allows your physician to optimize
your vision after your cataract surgery
rather than trying to predict how the
IOL will perform in your eye before
your surgery.
RxSight offers two lenses in the
Light Adjustable Lens platform: the
Light Adjustable Lens (LAL®) and the
Light Adjustable Lens+™ (LAL+™).
Your doctor will determine the lens
that is best suited to your eyes. Both
the LAL and LAL+ provide the same
opportunity to customize your vision
with your doctor after surgery. With the Light Adjustable Lens, you will
have the unique opportunity to adjust
and preview your vision based on your
personal desires and lifestyle requirements.
This optimization is done by your eye
doctor after lens implantation through a
series of light treatment procedures that
take only a few minutes each.
The Light Adjustable Lens delivers
superior vision outcomes that nonadjustable
IOLs cannot match.
In a study of 600 subjects, those
who received the LAL followed by
adjustments were twice as likely to
achieve 20/20 vision at 6 months
without glasses as those who received
a standard (fixed) monofocal IOL.1
Achieving Customized
Vision With The Light
Adjustable Lens
The Light Adjustable Lens is made of
a special photosensitive material that
changes the shape and power of your
implanted lens in response to ultraviolet
(UV) light. Light treatments are
delivered in your doctor’s office with
the Light Delivery Device (LDD) after
your eye has healed.
You will preview possible vision
outcomes with your doctor and choose
a prescription for your adjustable lens
based on your preferences and lifestyle
requirements. After surgery, you can test
drive your vision and customize it further
through a series of light treatments that
precisely reshape your implanted lens to
the correction that is needed.
Light Treatments
With your doctor’s input, the LDD
noninvasively delivers UV light to your
Light Adjustable Lens to adjust your
vision to the desired target. The system
gives your doctor the flexibility to make
adjustments and refinements to meet
your specific criteria.
Between 3 and 5 total light treatments,
each lasting approximately 90 seconds,
are required. The total number of light
treatments is based on achievement
of the desired visual outcome that
you and your doctor selected. Once
you have achieved your final optimal
vision, the lens power is permanently
locked with two final light treatments
to prevent any further changes. When
you experience the results of your
adjustments, you will better understand
the value of adjusting and customizing
your vision after your surgery.
What To Expect
After Surgery
In the weeks following your surgery,
you and your doctor will work together
to optimize your vision using UV light
treatments. During this period, you
will need to wear UV-blocking glasses
provided to you by your doctor. These
glasses will protect your eyes from
exposure to all other sources of indoor
and outdoor UV light, which can cause
uncontrolled changes to the Light
Adjustable Lens.
The UV protective glasses should be
worn from the time of lens implantation
until 24 hours after your last light
treatment is completed. At that point,
no further changes can be made to
the implanted Light Adjustable Lens,
and you can remove the UV protective
glasses and enjoy your custom vision!
Who Can Benefit
From The Light
Adjustable Lens?
The U.S. Food and Drug Administration
has approved the Light Adjustable Lens
and Light Delivery Device for patients
with preexisting astigmatism of 0.75
diopters or more who are undergoing
cataract surgery.
IMPORTANT SAFETY INFORMATION
Approved use: The Light Adjustable Lens™ (LAL®), Light Adjustable
Lens+™ (LAL+™), and Light Delivery Device™ (LDD™) system
is approved for patients who have a cataract and need surgery for
it, have corneal astigmatism (at least 0.75 diopters) before surgery,
and do not have preexisting macular disease.
Who should not receive this treatment? The LAL/LAL+ and LDD
system should not be used if you are taking medications that may
increase your sensitivity to ultraviolet (UV) light; if you are taking
a medication that is considered harmful to your retina; if you have
a history of herpes eye infection or uncontrollable eye movements
(nystagmus); or if you are unable to comply with your doctor’s
schedule of LDD light treatments and instructions for wearing
special UV-protective glasses for several weeks following cataract
surgery.
What warnings should I be aware of? Preexisting macular disease
and certain eye conditions may increase the risk of complications.
Your doctor will determine if you are a good candidate for the
LAL/LAL+. If you have any complications during your cataract
surgery before the LAL/LAL+ is implanted, you may need to have
another intraocular lens (IOL) implanted instead of the LAL/LAL+.
What precautions should I be aware of? The safety and effectiveness
of the LAL and LDD have not been established in patients
with certain preexisting eye conditions or in patients who experience
certain complications during cataract surgery. The safety and
effectiveness of the LAL+ has not been substantiated in clinical
trials. The effect of the LAL+ optical design on quality of vision,
contrast sensitivity, and subjective visual disturbances have not
been evaluated clinically. You should discuss these issues with your
doctor.
Following surgery, you must wear the special UV-protective
glasses during all waking hours for about 4 to 5 weeks and comply
with your doctor’s schedule of LDD light treatments. Failure to
wear the UV-protective glasses can result in an unpredicted vision
change or loss of vision quality after exposure to UV light, such as
from sunlight. This may require a second surgery to remove the
LAL/LAL+ from your eye and replace it with another IOL.
What are the potential risks? As with any surgical procedure,
there are risks associated with cataract surgery and IOL implantation.
Please discuss these risks with your doctor. Potential risks associated
with LDD light treatments include mild alterations to color
perceptions; temporary scratchiness, irritation, or dryness to the
front part of your eye; and activation of a previously undiagnosed
herpes eye infection. Longer lasting and serious adverse events
related to the UV light exposure are possible, but rare. There is a
small chance that your vision could be made worse or that you
may require additional surgery as a result of a complication.
Caution: Federal law restricts this device to sale by or on the order
of a physician.
How does the Light Adjustable Lens™ work?
The Light Adjustable Lens (LAL®) is made of a special photosensitive material that changes the shape and power of the implanted lens in response to ultraviolet (UV) light. The light treatments are delivered by the RxSight Light Delivery Device (LDD), which are done in your doctor's office. What makes the Light Adjustable Lens so unique is that these changes are made to the lens after it has been implanted in your eye and you have healed from surgery.
What should I expect in the period after cataract surgery?
Please follow all instructions provided to you by your eye doctor and staff, including use of the UV-blocking glasses that will be provided to you. As with any cataract surgery, your vision may not be perfect after surgery. While your eye doctor selected the lens they anticipated would give you the best possible vision, it was only an estimate. Fortunately, you have selected the Light Adjustable Lens! In the following weeks, you and your eye doctor will work together to optimize your vision. Please make sure to pay close attention to your vision and be prepared to discuss preferences with your eye doctor.
Why do I have to wear UV-blocking glasses?
The UV-blocking glasses you are provided with protect the Light Adjustable Lens from UV light sources other than the LDD that your doctor will use to optimize your vision. Exposing the Light Adjustable Lens to other UV light sources can potentially change the lens correction in an uncontrolled manner. If you do not wear the provided UV-blocking eyewear, your vision may not improve or it could get worse. If this happens, please contact your physician.
How long do I have to wear the UV-blocking glasses?
The UV-blocking glasses should be worn at all times until your eye doctor tells you that you no longer need to wear them (usually 24 hours after your final light treatment). Total wear is typically about 4-5 weeks in duration, however, this may vary depending on the number of light treatments delivered.
Can I wear my regular sunglasses that have UV protection?
No. You should wear the UV-blocking glasses provided to you. These glasses have a special protective coating that no other glasses have.
What happens if I lose or break my UV-blocking glasses?
Please notify your eye doctor/clinic as soon as possible if one of your two pairs of UV-blocking glasses are lost, damaged or unwearable, and then continue to wear the other pair. If both pairs are lost or damaged, wear the darkest sunglasses you have and contact your eye doctor/clinic.
What can or can I not do after surgery?
Showering - If there is a window or possible direct sunlight in your shower, please wear the UV-blocking glasses in the shower or consider showering after the sun has gone down or before it comes up. If there is no direct sunlight, you do not need to wear your UV-blocking glasses when you shower. However, please put them on immediately afterwards.
Sports - Your eye doctor will advise you when you can return to sports. Your return to more impactful activities may need to be delayed until all light treatments are complete to guarantee a stable Light Adjustable Lens for light treatments.
Tanning Studio - A tanning studio bed is a very strong source of UV light, and should be avoided until all light treatments are complete and you have been advised that you can remove your UV-blocking glasses.
Makeup - Your eye doctor will advise you when you can return to wearing eye makeup. Be careful when removing eye make-up and do not place excessive pressure on the eye. Permanent make-up should be delayed until the eye is considered fully healed by your eye doctor.
Travel - Travel is not impacted. Be sure to remember to bring all of your UV-blocking glasses with you. Be particularly diligent in protecting the eyes from UV sources in unfamiliar environment.
Work - Work is not impacted, unless your profession puts you at a higher risk of UV exposure. Please remember to wear your UV-blocking glasses at work until you are told by your eye doctor that it is no longer necessary.
Laser Hair Removal - It is recommended that you wait until all light treatments are complete and you have been advised that you can remove your UV-blocking glasses before proceeding with hair removal (IPL) treatments (different IPL devices use different wavelengths). This should include other facial beauty treatments that use light sources.
What should I do if I forgot to wear my UV-blocking glasses?
It is very important that you do not forget to wear your UV-blocking glasses. However, if you do forget, please put them on as soon as you remember.
How many total light treatments will I need?
Between 1 and 3 light treatments, each lasting approximately 90 seconds and separated by approximately 3 days, are required. The total number of light treatments is based on the achievement of the desired visual outcome that you and your doctor selected. Once you have achieved your final optimal vision, the lens power is permanently locked with two final light treatments to prevent any further changes.
Are the light treatments painful?
Numbing drops will be applied to your eye. There may be some mild pressure or discomfort, and some patients have perceived the treatment to be bright, however the light treatments should not be painful.
What should I expect after each light treatment?
Your vision may be blurry immediately after each treatment due to a gel used during application of the light treatment, but this should resolve quickly. Additionally, your eye may be dilated for the treatment, which may require wearing the tinted UV-blocking glasses for a few hours. It may take approximately 24 hours after each light treatment to notice an improvement in your vision. The light from the LDD may also cause a temporary or long-lasting pink or red afterimage, which is common with a light source directed to the eye. This tinge to your vision is especially noticeable on things that normally look white, but should resolve before your next light treatment. Speak with your doctor if the pink or red after image remains.