Alcon
AcrySof ReSTOR Lens Implants:
Harvard Eye Associates — 30 Years
of Lens Implant Experience!
The AcrySof ReSTOR lens.
Sight changing, life changing.
Frequently Asked Questions
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
Do I qualify for the ReSTOR lens
implant?
Please call Harvard Eye to schedule your qualifying 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.
What can I expect after my procedure?
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. 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.
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.
Our Promise
As always, Harvard Eye is first and foremost concerned about
what is best for each individual patient. Call us today for
your personalized consultation!
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