Cataract Extraction Clinical Trial
Official title:
Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal IOL.
Cataract is prevalent throughout the world and IOLs are routinely implanted after the
extraction of the cataractous lens. It is the most frequently performed surgery in the
United States with an estimated 2-3 million procedures performed annually. With the aging
population on the rise, as well as the increasing popularity of refractive intraocular
lenses, the number of intraocular surgeries continues to rise. Over the years, the surgical
technique has evolved from intracapsular extraction to modern phacoemulsification. This
development has helped with the evolution of IOLs as well. The IOLs have advanced
extensively: different materials and designs are available, permitting implantation through
smaller, sutureless incisions. Traditional IOLs are of monofocal design providing vision at
one distance, typically far. Patients implanted with traditional monofocal IOLs usually
require glasses for near distance tasks such as reading. The new multifocal IOLs offer the
possibility of seeing well at more than one distance, without glasses or contacts.
The AcrySof ReSTOR (Alcon Laboratories) uses apodized diffractive technology — a design that
responds to how wide or small the eye's pupil might be — to provi de near, intermediate, and
distance vision. Clinical studies used to support the March 2005 FDA approval showed that
80% of people who received the lens did not use glasses for any activities after their
cataract surgery; 84% who received the lens in both eyes had distance vision of 20/25 or
better, with near vision of 20/32 or better. Wavefront analysis is a technique currently
used to measure the aberrations of the entire optical system. The term aberration derives
from the Latin ab-erratio, which means going offtrack or deviating. Therefore, and
aberration is the difference that exists between the ideal image of that we would expect to
see when the luminous rays are refracted in the perfect optical system (Snell's law) and
what is actually achieved. This technology is widely used in refractive surgery with
successful outcomes. With the introduction of wavefront analysis, a new tool is available to
re-design and study the performance of IOLs. Regarding IOL design, it has been used to
modify the IOL to partially compensate for the average spherical aberration. The goal is to
improve the ocular optical quality of pseudophakic patients. Clinical results using the
aspheric monofocal IOLs confirm that this modification leads to a significant improvement,
particularly in contrast sensitivity, mesopic visual quality and reduction of high order
aberrations mainly spherical aberration when compare to spherical IOLs. The new aspheric
ReSTOR IOL is the first single piece acrylic multifocal IOL to be available in the United
States and a comparison to a regular (spherical) multifocal IOL is necessary to determine if
the aspheric ReSTOR lens shows the same improvement.
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after
bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare
it to a historical control group of patients implanted bilaterally with the spherical ReSTOR
multifocal IOL.
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Observational Model: Case Control, Time Perspective: Retrospective
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