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The AcrySof® ReSTOR® lens delivers the
potential for freedom from reading glasses or bifocals for cataract
patients to improve vision for everyday life.
How does the performance of the AcrySof®
ReSTOR® lens compare with conventional monofocal lenses?
During the clinical study, four out of five
AcrySof® ReSTOR® patients found that they no longer needed their
glasses after having the lens implanted in both eyes, compared to
only 8% of patients with monofocal lenses.
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Other advantages include:
• Full range of vision. With this increase in
vision quality, AcrySof® ReSTOR® patients would be able to pass the
visual acuity portion of the driver's license exam in most states.
• The ability to read small type quickly and
easily. While only one of 13 patients with the other IOL could read
small type, four of five AcrySof® ReSTOR® patients were still able
to read small type.
• Better vision in all lighting situations.
Whether in brightly or dimly lit conditions the apodized diffractive
optics of the AcrySof® ReSTOR® lens minimizes the occurrence and
severity of visual disturbances compared to other multifocal
technology
As with any surgical procedure,
there are associated risks and benefits. While there may be a
decrease in the need for glasses some patients may notice rings
around lights at night. These side effects may make it more
difficult to drive at night or perform tasks in low light
conditions. While virtually everyone experiences an improvement in
vision after cataract surgery, some people will have better
uncorrected vision than others. Therefore, it is important to
discuss the potential risks and benefits with your doctor who will
let you know if the AcrySof® ReSTOR® lens is right for you.
The ReStor Lens
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The ReStor lens has an
overall design very similar to other single-focus lenses. The
optical surface has concentric rings of differing focus as shown
in the higher-magnification image at right, below. Sharp
distance vision is afforded by the more peripheral portion of
the lens (like the upper part of a bifocal lens in a pair of
glasses), while sharp near vision is provided by focal
properties of the more central portion of the lens (like the
reading portion of a bifocal lens). The multiple concentric
rings of different focus in this lens effect a much broader
range of focus than a single-focus lens implant, through both
refractive and diffractive optics. This lens received FDA
approval in April '05, after review of 3-year safety and
efficacy data in clinical studies
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A multifocal lens implant
like ReStor, should be distinguished from other lens implant
designs that enable focus at multiple distance ranges. Other
methods of adjusting focus include:
1. Change of focus by
effecting a position change within the eye with focusing effort,
as with the CrystaLens, and
2. Change in focus through
shape change of the lens itself, as with the eye's natural lens.
One challenge with
multifocal lenses, as anyone who has worn bifocals will
acknowledge, is that the "near" portion of the lens can cause
blur when viewing objects at distance, and vice versa. Another
concern with older diffractive implant lenses is that the ridges
on the lens can cause some 'edge effects' including glare, halo,
and reduced contrast sensitivity under certain viewing
conditions. The precise engineering and fabrication of the
ReStor lens (referred to as an "apodized diffractive optic") has
overcome many of these concerns.
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ReStor Clinical
Data
Data from clinical trials
presented to the US FDA is reviewed below. These studies represent
data from patients followed for 3 years after implantation of the
ReStor lens. In addition to the data presented below, there were no
cases of lens-related complications, and no cases of lens removal
for undesirable optical consequences or effects.
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Glasses Use After Surgery: ReStor vs. Control |
Percentage of patients
wearing eyeglasses after lens implantation. In the ReStor
group (orange) 80% never wore glasses after implantation of
this lens in both eyes, compared to 5% of patients that had
monofocal (traditional or standard) lens implantation.
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Near Vision After ReStor Implantation |
Breakdown of near vision
results in the ReStor group (both eyes having Restor lens
implantation) compared to a control group (both eyes having
monofocal lens implantation). Near vision acuity scores were
significantly better in the ReStor group (orange), compared to
the control group (yellow).
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Distance Vision After ReStor Implantation |
Comparison of distance
vision in the ReStor group (ReStor lenses in both eyes)
compared to control group (monofocal lenses in both eyes).
Distance vision scores were comparable in both groups,
suggesting that the multifocal lens design of ReStor does not
contribute to any decrease in distance vision.
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