Evaluation of the Aspheric ReSTOR Intraocular Lens (IOL) After Routine Cataract Extraction
Condition: Cataract Extraction; Refractive Surgery
MeSH terms: Cataract
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): aspheric ReSTOR multifocal intraocular lens (IOL)
Intervention type(s): Device
Intervention description(s): Multifocal intraocular lens
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        aspheric ReSTOR multifocal intraocular lens (IOL)
      
Keywords: Visual Outcomes; Patient Satisfaction; Cataract Extraction