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Comparison of Functional Vision Provided by AMO Tecnis Z9000 and Alcon SA60AT Acrysof

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00459303
First received: April 10, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cataract
 Device: AMO Tecnis Z9000
Device: Alcon SA60AT Acrysof
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Intraidivisual Comparison of Functional Vision Provided by AMO Tecnis Z9000 and ALcon SA60AT Acrysof Posterior Chamber Intraocular Lenses

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • best corrected log contrast sensitivity at photopic condition
  • best corrected logMAR contrast acuity at both photopic and mesopic conditions

Secondary Outcome Measures:
  • Corneal high-order aberrations
  • Total ocular high-order aberrations

Estimated Enrollment: 30
Study Start Date: October 2005
Estimated Study Completion Date: December 2007
Detailed Description:

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.

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
  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Preoperative ocular pathology potentially affect visual acuity. EX: diabetic retinopathy, macular degeneration, corneal opacity, glaucoma, visual field defect...etc.
  • Previous ocular surgery. Ex: refractive surgery, vitreoretinal surgery...etc.
  • Patients who cannot cooperative with the study procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459303

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Pei-Yuang Su         patsysu624@yahoo.com.tw    
Principal Investigator: Pei-Yuang Su, MD            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Pei-Yuang Su, MD National Taiwan Unoversity Hospital
Study Chair: Fung-Rong Hu, MD National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00459303     History of Changes
Other Study ID Numbers: 05012006
Study First Received: April 10, 2007
Last Updated: April 10, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
cataract
aspherical intraocular lenses
functional vision

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013