Comparison of Functional Vision Provided by AMO Tecnis Z9000 and Alcon SA60AT Acrysof - Full Text View

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00459303

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 IV

MedlinePlus related topics: Cataract

Drug Information available for: Dipivefrin Dipivefrin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Intraidivisual Comparison of Functional Vision Provided by AMO Tecnis Z9000 and ALcon SA60AT Acrysof Posterior Chamber Intraocular Lenses

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:

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.
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.
Pupil diameters: measured by Colvard infrared pupillometer (Oasis. Medical, Glendora, CA, USA )under both photopic and mesopic luminance levels.
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).
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

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

Keywords provided by National Taiwan University Hospital:

cataract
aspherical intraocular lenses
functional vision

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on May 07, 2009