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

NCT ID: NCT00459303

Last Updated: 2014-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-12-31

Brief 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

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intraocular lens

patients with bilateral clinical significant cataract reisiceved cataract surgeries and recieved spherial intraocuar lens(SA60AT, Alcon) in one eye and aspherical intraocular lens(Tecnis Z9000, AMO)in the other respectively.

Group Type: ACTIVE_COMPARATOR

aspherical intraocular lens

Intervention Type: DEVICE

implantation of aspherical intraocular lenses(AMO Tecnis Z9000)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)

spherical intraocular lens

Intervention Type: DEVICE

implantation of spherical intraocular lenses(Alcon SA60AT Acrysof)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)

Interventions

aspherical intraocular lens

implantation of aspherical intraocular lenses(AMO Tecnis Z9000)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)

Intervention Type: DEVICE

spherical intraocular lens

implantation of spherical intraocular lenses(Alcon SA60AT Acrysof)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)

Intervention Type: DEVICE

Other Intervention Names

AMO Tecnis Z9000; Alcon SA60AT Acrysof

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei-Yuang Su, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan Unoversity Hospital

Fung-Rong Hu, MD

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

05012006

Identifier Type: -

Identifier Source: org_study_id