Comparison of Functional Vision Provided by AMO Tecnis Z9000 and Alcon SA60AT Acrysof
Information source: National Taiwan University Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract
Intervention: AMO Tecnis Z9000 (Device); Alcon SA60AT Acrysof (Device)
Phase: Phase 4
Sponsored by: National Taiwan University Hospital
Official(s) and/or principal investigator(s):
Pei-Yuang Su, MD, Principal Investigator, Affiliation: National Taiwan Unoversity Hospital
Fung-Rong Hu, MD, Study Chair, Affiliation: National Taiwan University Hospital
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.
Official title: Intraidivisual Comparison of Functional Vision Provided by AMO Tecnis Z9000 and ALcon SA60AT Acrysof Posterior Chamber Intraocular Lenses
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
best corrected log contrast sensitivity at photopic condition
best corrected logMAR contrast acuity at both photopic and mesopic conditions
Corneal high-order aberrations
Total ocular high-order aberrations
In this prospective study, 30 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.
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,
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.
- Mann-Whitney U matched-paired test was used with STATA software
- P values of 0. 05 or less were considered statistically significant
Minimum age: 45 Years.
Maximum age: 80 Years.
- Bilateral cataracts, eligible for phacoemulsification with primary implantation of a
posterior chamber IOL
- Willing and able to comply with scheduled visits and other study procedures
- Preoperative ocular pathology potentially affect visual acuity. EX: diabetic
retinopathy, macular degeneration, corneal opacity, glaucoma, visual field
- Previous ocular surgery. Ex: refractive surgery, vitreoretinal surgery...etc.
- Patients who cannot cooperative with the study procedures
Locations and Contacts
National Taiwan University Hospital, Taipei, Taiwan; Recruiting
Pei-Yuang Su, Email: email@example.com
Pei-Yuang Su, MD, Principal Investigator
Starting date: October 2005
Last updated: April 10, 2007