Comparison of Functional Vision Provided by AMO Tecnis Z9000 and Alcon SA60AT Acrysof
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to compare intraindividually the functional vision provided by two different
      posterior chamber intraocular lenses: AMO Tecnis Z9000 and Alcon SA60AT Acrysoft. To see if
      the aspherical intraocular lenses provide better functional vision than traditional spherical
      intraocular lenses.
    

Detailed description: 
      In this prospective study, 20 patients with bilateral catarct presenting for cataract surgery
      are randomly assigned to recieve an aspherical intraocular lens(AMO Tecnis Z9000) in one eye
      and a spherical intraocular lens(Alcon SA60AT Acrysof)in the other. All surgeries are
      performed by one experienced surgeon(Fung-Rong Hu,MD)with clear cornea small incision
      phacoemulsification and in-the-bag posterior chamber intraocular implantation.

      The patients are followed for 3 months, and postoperative contrast sensitivity, contrast
      acuity, corneal & total ocular high-ordered aberrations are measured and compared
      intraidividually between two different IOL groups.

      Outcome Measurement:

        1. Contrast sensitivity testing: measured with spectacle correction for the target distance
           of three meters using wall-mounted FACT sine-wave grating chart with nine levels of
           contrast.The graphic contrast sensitivity is recorded as a log functional units on the
           y-axis and displayed for five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per
           degree (cpd))on x- axis.

        2. Contrast acuity testing: measured with spectacle correction for the target distance of
           three meters using logMAR letter chart(Precision Vision®)represented on a wall-mounted
           illuminator cabinet.Two types of contrast charts are used, high contrast(Cat.No.2103
           SLOAN translucent chart)and low contrast(Cat.No.2132 10% SLOAN translucent chart),and
           are tested under both photopic and mesopic conditions.

        3. Pupil diameters: measured by Colvard infrared pupillometer (Oasis. Medical, Glendora,
           CA, USA )under both photopic and mesopic luminance levels.

        4. Corneal aberration analysis: performed with TMS-4 (Tomey, Japan).The corneal HOAs are
           described with Zernike polynomials of 3rd-to 5th- order root-mean-square(RMS)of central
           6mm diameter using VOLPro 6.89 software(Fa. Sarver and Associates, Carbondale. Ill,
           USA).

        5. Total ocular aberration analysis: performed with a Hartmann-Shack aberrometer(Zywave,
           Bausch & Lomb Inc., Rochester, New. York)under maximal mydriasis with
           Mydrin-P(phenylephrine hydrochloride 0.5% and tropicamide 0.5%, Santen).The wavefront
           errors were described using Zernike polynomials RMS for total HOA at pupil diameter of 5
           mm and 6 mm, primary spherical (Z 4,0) and 3rd-to 5th-order aberration at pupil diameter
           of 6 mm.

      Data Analysis:

        -  Mann-Whitney U matched-paired test was used with STATA software

        -  P values of 0.05 or less were considered statistically significant
    

Intervention name(s): aspherical intraocular lens; spherical intraocular lens
Intervention type(s): Device; Device
Intervention description(s): implantation of aspherical intraocular lenses(AMO Tecnis Z9000)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation); implantation of spherical intraocular lenses(Alcon SA60AT Acrysof)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)
Other intervention name(s): AMO Tecnis Z9000; Alcon SA60AT Acrysof
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cataract; aspherical intraocular lenses; functional vision