Alcon ReSTOR Lens

Frequently Asked Questions

Here are answers to some commonly asked questions about ReSTOR lens implant.

Who is a candidate for this procedure?

Although ReSTOR lenses are a breakthrough technology initially approved for cataract patients, with or without presbyopia (inability to read close up after age 45), it is not necessary to need cataract surgery to utilize the ReSTOR lens, just the desire to restore eyesight at a range of distances without corrective eyewear.  In the absence of a cataract, the procedure would be a Refractive Lens Exchange, and this would represent an off-label use of the ReSTOR lens, which is currently only FDA approved for use in cataract surgery.  A careful examination and discussion with Dr. Seibel will determine if you are a candidate for this lens implant.

Based on the FDA clinical trials, Alcon has indicated the following types of patients should not have the AcrySof ReSTOR lens:

• Patients that are hypercritical with unrealistic expectations
• Patients with excessive complaints about their prescription
• Patients who drive at night for a living or whose occupation or hobbies depend on good night vision
• Patients who are amateur or commercial airline pilots
• Patients who have lifelong complaints about glare and halos or are bothered by glare at night
• Patients who are satisfied with wearing glasses
• Patients who want guarantees on surgical outcomes

How do I find out if I qualify as a candidate for the ReSTOR lens implant?

Please call our office to schedule an exam. The best candidates will be those that have a strong desire to see well without glasses and have realistic expectations. Patients with ocular disease may not be good candidates for this implant. To find out if you are a candidate for this breakthrough in vision care and cataract surgery or simply for more information, please call us at Seibel Vision Surgery, (310) 444-1134.

What can I expect after my procedure?

Similar to other lens implant procedures, you can expect your vision to often be improved the day following surgery and vision typically further improves gradually over the next few weeks.

How soon after the procedure will I be able to see at varying distances?

For most patients, near vision is good the next day, and both near and distance vision improves over the following weeks. Studies have shown that results are best when both eyes have ReSTOR lenses implanted. We usually wait 2-4 weeks between implants.

How many patients are 100% glasses free after having this procedure?

The results are very good. After having ReSTOR lenses implanted, 80% of patients say they never wear glasses. Nearly 94% were so satisfied that they would have the procedure again.

When did ReSTOR receive FDA approval?

March 23, 2005. It has been approved for use in Europe since April 4, 2003.

How many people in the US have had the ReSTOR lens procedure?

During clinical trials, 566 people received the ReSTOR lens. However, ReSTOR is the same type of lens implant (acrylic lens) that has been in used in cataract surgery for many years, in hundreds of thousands of patients.

What are the risks/contraindications of this procedure?

While very rare, the dominant risk in any surgery is infection. Patients receive both preoperative antibiotics and postoperative antibiotics to minimize this risk. Lens implant surgery is one of the most successful and commonly performed surgeries in the US.

Is this a reversible procedure?

Once the natural lens is removed, it cannot be replaced. However, if one is over 40 and dependent on reading glasses or bifocals, the natural lens has already lost significant accommodative ability. If the patient desires, the ReSTOR lens implant can be removed and replaced. During the FDA Clinical Trials for the ReSTOR lens, only two out of the 450 implants needed to be explanted due to patient dissatisfaction - because the benefit of a full range of vision outweighed any complaint of visual disturbance. The only medical indication for lens replacement would be if the lens power needed to be changed, which is uncommon due to advanced eye measurements and calculations that Dr. Seibel performs prior to surgery.

About the FDA clinical trials and results:

In clinical trials for ReSTOR, Alcon reported that 80 percent of patients reported 'never' wearing reading glasses or bifocals following bilateral cataract surgery. Clinical results showed 84 percent of patients receiving the ReSTOR lens in both eyes achieved distance visual acuity of 20/25 or better, and near visual acuity of 20/32 or better without glasses. That compared with only 23 percent of the control group.

Multi-center clinical studies were conducted in the United States and Europe to establish the safety and effectiveness of the AcrySof ReSTOR IOL. In the clinical study, 566 patients received the AcrySof ReSTOR IOL and 194 received the AcrySof monofocal IOL as a control. The mean age for the total population was 69 years. In the study, 88 percent of patients who received the AcrySof ReSTOR IOL achieved distance visual acuity of 20/25 or better without correction by contacts or glasses compared to 92 percent for the monofocal control group, reflecting that the two lenses were statistically equivalent at this level of distance visual acuity.

As for near vision, following bilateral implantation (implantation in both eyes), 74 percent of patients receiving the AcrySof ReSTOR achieved near visual acuity of 20/25 (J1) or better without correction by contacts or glasses, while only 14 percent of the monofocal control group achieved this level. In addition, 85 percent of the AcrySof ReSTOR IOL patients achieved functional binocular uncorrected intermediate vision (20/40 or better (J3) measured at standard 60 cm computer screen working distance) compared to 67 percent of monofocal control patients. J1 means patients can read the very small stock quotes in the newspaper, while J3 means patients can read the normal newspaper type size.

This exceptional visual performance was independent of pupil size and was accomplished by the optics of the lens without physical movement of the lens inside the eye, making visual outcomes highly predictable. As a result, 80 percent of AcrySof ReSTOR patients reported never using glasses for either near or distance vision, compared to only 8 percent of the monofocal control patients. This is the first time this level of spectacle independence has been achieved.

Contrast Sensitivity

Contrast sensitivity data presented presented by Alcon shows that at lower spatial frequencies there was no clinically or functionally significant difference between AcrySof ReSTOR and monofocal control subjects. Other studies indicate that these lower spatial frequencies are most important in terms of vision related to everyday life skills, such as walking, driving, and reading.

How Does the ReSTOR compare to the CrystaLens?

Both lenses are designed to reduce a patient's need for reading glasses while retaining good distance vision without glasses. In general terms, the ReSTOR lens tends to offer better sustained reading ability at a closer range, around 10" away, which some patients can find a little closer than they are used to. By comparison, the CrystaLens statistically does not give quite as strong a sustained reading ability for these closer distances, and patients desiring to read for more prolonged periods may wish to supplement with a weak pair of reading glasses, such as +1.25 diopters (as compared to the much stronger +2.50 diopters usually required by patients with a standard monofocal IOL).

When comparing lens implants for intermediate distance around 24 inches (e.g. computer monitor), the ReSTOR tends to not be quite as sharp as it is at the closer reading distance of 10 inches. By comparison, the CrystaLens tends to be sharper at intermediate distances.

With regard to glare, the ReSTOR lens is more likely than a standard IOL to produce such phenomena as rings or haloes around street lights or headlights. In the FDA study, 74% of ReSTOR patients rated glare as mild to none, while 21% thought it was moderate, and 5% thought it was severe. The high satisfaction rate with the ReSTOR lens would seem to indicate that patients felt that glare symptoms were more than compensated for by their reduced dependence on glasses. The ReSTOR glare rates compared to standard monofocal lens implant patients who rated glare as 91% mild to none, 7% moderate, and 2% severe. The CrystaLens data generally showed no more increased risk of glare than with a standard monofocal lens implant.

Your individual exam may indicate that one lens may be better suited to you than another, and perhaps neither one may be as appropriate as a standard monofocal lens implant. Dr. Seibel will of course discuss this with you after a thorough consultation.

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As always, Seibel Vision Surgery is first and foremost concerned about what is best for each individual patient. Call us today for your personalized consultation!