Comparison of the Quality of Vision Provided by AMO Tecnis Z9000 and Alcon Laboratories MA60 Acrysof Posterior Chamber Intraocular Lenses
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a comparison of the quality of vision provided by AMO Tecnis Z9000 three-piece
      silicone posterior chamber intraocular lens and Alcon Laboratories MA60 three-piece acrylic
      posterior chamber intraocular lens.
    

Detailed description: 
      Today, intraocular lenses (IOLs) are routinely implanted after cataract extraction. Cataract
      surgical techniques are constantly developing due to innovations in surgical implantation and
      IOL manufacturing processes. Although material development and surgical implantation have
      advanced extensively during the past several years, there has been little attention paid to
      the improvement of the optical quality of IOLs.

      It has been documented that the vision of an IOL patient is no better than that of a person
      with healthy eyes of a similar age, i.e., when a 65-year-old patient with cataracts has them
      removed and implanted with an IOL, the resulting visual outcome is no better than the visual
      quality of a 65-year-old without cataracts. The fact that the visual quality of the IOL
      patients is no better than that of their same-age counterparts is surprising because an IOL
      is optically superior to the natural crystalline lens. This fact may be explained by
      aberrations.

      Aberrations cause incoming light that would otherwise be focused to a point to be blurred,
      which in turn causes a reduction in visual quality. This reduction in quality is more severe
      under low luminance conditions because ocular aberrations increase when the pupil size gets
      larger. The Z9000 is an IOL that is designed to counteract the spherical aberration of the
      cornea and thus improve the resulting visual quality of IOL patients.

      Different materials and lens designs result in different visual quality. The handling of the
      lens, proper centration in the eye, the postoperative course, and the optical image may vary
      depending on the design of the lens. Two lenses will be compared: AMO Tecnis Z9000
      three-piece silicone lens and Alcon Laboratories MA60 three-piece acrylic lens.

      This will be a randomized, evaluator-masked study in bilateral cataract surgery patients.
      Each patient will be assigned to a AMO Tecnis Z9000 lens in one eye and an Alcon Laboratories
      MA60 lens in the other eye. All first surgeries will be on the right eye. A randomization
      list will be used to decide lens allocation.

      A total of 80 patients (men and women) from the Singapore National Eye Centre will be
      enrolled in the study. All patients will undergo wavefront analysis 90-120 days
      postoperatively.

      The two lens models look different, even in the eye, after implantation. It is not possible
      to mask the individual investigator at the time of surgery or personnel responsible for
      conducting the clinical ocular examinations (e.g., evaluation of complications, posterior
      capsule, IOP, pupil size) and optic evaluations (e.g., evaluation of the IOL).
    

Intervention name(s): Tecnis Z9000 intraocular lens; MA60 intraocular lens
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Cataract; Intraocular lens; Aberration; Wavefront