Satisfaction & Spectacle Independence With ReSTOR 2.5 & ReSTOR 3.0 IOLs
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      Patients implanted with the ReSTOR 2.5 multifocal IOL in the dominant eye and the ReSTOR 3.0
      in the non-dominant eye have overall satisfaction and spectacle independence at least
      comparable to that with bilateral implantation of the 3.0 add lens. Glare and haloes and
      other unwanted visual side effects with this mixed combination of lenses is better than with
      bilateral 3.0 lenses.
    

Detailed description: 
      Patients desire spectacle independence for a range of distances, including distance,
      intermediate, and near. The ReSTOR 2.5 multifocal lens has been designed to allow better
      uncorrected intermediate vision and reduce glare and haloes compared to previous, higher-add
      models. However, their impact on overall patient satisfaction, glare & haloes (incidence and
      impact), and spectacle independence has not been examined with a patient-reported outcome
      study. Additionally, in clinical practice, many clinicians find that bilateral implantation
      of ReSTOR 2.5 yields insufficient near vision for about 30% of patients (1). For this reason,
      many surgeons prefer to implant the ReSTOR 2.5 in one eye (usually the dominant) and the
      ReSTOR 3.0 in the other eye.

      MDbackline is a multi-center patient-reported research engine that has been in use since 2013
      for data collection in several patient-reported outcome studies for major industry sponsors.
      Studies performed with MDbackline have been presented at major meetings and are in press with
      peer-reviewed journals. The investigators have previously conducted studies of patient
      satisfaction and spectacle independence with the higher add (3.0) multifocal lens prior to
      the approval of the ReSTOR 2.5. These data, which include about 85 patients, will be used as
      historical references. They showed a high degree of satisfaction and spectacle independence
      but complaints of glare and haloes in as many as 37% of patients ("a fair amount of glare" or
      more). (2) Since approval of the ReSTOR 2.5, the investigators have clinically observed far
      fewer complaints of glare/haloes when the lower-add lens is used in at least one eye.

      In this study the investigators propose to evaluate patients with the ReSTOR 2.5 lens in one
      eye and the ReSTOR 3.0 in the other using substantially the same questionnaire in the
      previous study described above. The investigators plan to compare results of these new data
      (2.5/3.0 combination) with the previous study data (3.0/3.0).
    

Intervention name(s): Survey
Intervention type(s): Device
Intervention description(s): Patients will complete a survey describing their satisfaction with vision after cataract surgery that was performed at least 2 months prior to study enrollment.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with healthy eyes and uncomplicated cataract surgery completed at least 2 months
        before a questionnaire is conducted.
      
Keywords: cataract