LIGHT ADJUSTABLE LENS™

The First and Only Lens That Can Be Customized AFTER Cataract Surgery

 

What Is a Cataract?

A cataract is a cloudy area in the normally clear lens of your eye, causing things to look blurry, hazy, or less colorful. Cataracts are a natural part of the aging process and, over time, can lead to vision loss and blindness. When a cataract interferes with your usual activities, such as reading and driving, your physician will likely recommend cataract surgery.

How Are Cataracts Treated?

The only treatment for cataracts is to remove the cloudy natural lens and replace it with a clear artificial lens. This lens is called an intraocular lens (IOL). Cataract removal 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 visual problems you may experience such as myopia (nearsightedness), hyperopia (farsightedness), astigmatism (irregularly shaped lens), or presbyopia (diminishing ability to focus with age).

Selecting the Right IOL

Your eye doctor uses pre-surgery eye measurements to estimate the power and type of IOL he or she thinks will provide you with the best vision after surgery.

Despite the number of measurements used to select the IOL and predict the visual outcome, only about 50% of patients achieve their targeted distance vision without glasses,1 and an even smaller percentage achieve excellent vision at all distances.

If the visual target is not achieved, this can only be corrected by glasses, contacts, additional surgery, or by lens removal and replacement.

1. 2016 IOL Report, A Global Market Analysis for 2015 to 2021. Market Scope LLC; 2016.

Light Adjustable Lens From RxSight®

With the Light Adjustable Lens, you can now customize your vision after your cataract surgery. You will have the unique ability to adjust and preview your vision until it meets your personal desires and lifestyle requirements.

The Light Adjustable Lens delivers superior visual outcomes that non-adjustable IOLs cannot match. In a study of 600 subjects, those who received the Light Adjustable Lens followed by adjustments were twice as likely to achieve 20/20 distance vision at 6 months without glasses as those who received a standard monofocal IOL.1

1. US FDA. Summary of Safety and Effectiveness (SSED) of Light Adjustable Lens and Light Delivery Device system.

How Does the Light Adjustable Lens Work?

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 to optimize your vision. These light treatments are delivered in your doctor’s office with the Light Delivery Device (LDD) after your eye has healed.

How Does the Light Adjustable Lens Work?

Macromers/Polymers are not visible in the lens, and graphic is used only as an illustration.

Surgical Implantation

If you select the Light Adjustable Lens, the first step is to have your cataract safely removed and the adjustable IOL implanted. The cataract removal and IOL implantation procedure is the same as if you selected a non-adjustable IOL.

After Cataract Surgery

After your Light Adjustable Lens has been implanted in your eye, it is adjusted to deliver the customized vision you desire. This means that there are 2 major differences following your surgery as compared to a non-adjustable IOL:

UV Protective Glasses

Exposure to indoor and outdoor sources of UV light can cause uncontrolled changes to the Light Adjustable Lens. To prevent this, you will be provided with UV protective glasses to wear immediately following surgery during all waking hours (from time of lens implantation until after the last light treatment is completed).

Your protective glasses may be removed when sleeping, and may be temporarily removed when showering, washing your face, or applying eye drops as long as you are not exposed to direct sunlight.

Twenty-four hours after your final light treatment, 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!

How Are the Light Treatments Performed?

Once your eye has healed, you will return to your eye doctor to have your vision tested. During this visit you will be able to preview and compare possible vision outcomes based on your unique preferences and lifestyle requirements before selecting a prescription for your adjustable lens.

To receive the light treatment, you will be placed in front of the Light Delivery Device (LDD). The LDD non-invasively delivers the UV light to precisely reshape your Light Adjustable Lens based on the visual correction that is needed to target your custom prescription.

Light Treatment Schedule

A minimum of 2 light treatments—each lasting approximately 90 seconds and separated by approximately 3 days—are required. The total number of light treatments is based on achievement of the desired vision outcome that you and your doctor selected.

Once you have achieved your final optimal vision, the lens power is permanently locked in with a final light treatment to prevent any further changes.

Who Can Benefit?

The U.S. Food and Drug Administration has approved the Light Adjustable Lens and Light Delivery Device for patients with pre-existing astigmatism of 0.75 diopters or more who are undergoing cataract surgery.

Other commercially available IOLs may be available for the treatment of your cataracts and your doctor will help you determine which lens is right for you.

Ask your doctor to explain the possible risks and benefits of cataract surgery. For risks and benefits specifically related to the RxSight Light Adjustable Lens, please see the next slide.

Important Safety Information

Approved use: The Light Adjustable Lens 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 Light Adjustable Lens 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 Light Adjustable Lens. If you have any complications during your cataract surgery before the Light Adjustable Lens is implanted, you may need to have another intraocular lens (IOL) implanted instead of the Light Adjustable Lens.

What precautions should I be aware of? The safety and effectiveness of the Light Adjustable Lens and LDD have not been established in patients with certain preexisting eye conditions or in patients who experience certain complications during cataract surgery. 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 Light Adjustable Lens 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.

®2021 RxSight. All Rights Reserved. COM 0019 Rev. B