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

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: aspherical intraocular lens; Device: spherical intraocular lens

• Registration Number: NCT00459303
• Lead Sponsor: National Taiwan University Hospital

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-04-10
• Study First Submitted QC: 2007-04-10
• Study First Posted: 2007-04-11
• Primary Completion: 2007-09
• Study Completion: 2007-12
• Results First Submitted: 2009-10-05
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-29
• Last Update Submitted: 2013-12-29
• Results First Posted: 2014-02-17
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intraocular lens	aspherical 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.
intraocular lens	spherical 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.

Primary Outcome Measures

Name	Time	Method
Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition	average data of post-op 3rd, 6th, 12th week measurements	Contrast acuity testing was measured with spectacle correction for the target distance of three meters using a logMAR letter chart (Precision Vision®) represented on a wall-mounted illuminator cabinet. Two types of contrast charts were used, high contrast (Cat.No.2103 SLOAN translucent chart) and low contrast (Cat.No.2132 10% SLOAN translucent chart), and these were tested under both photopic (250 Lux) and mesopic (0.5 Lux) conditions. The contrast acuity tested ranges from 20/160 to 20/20(from worse to best), which equals LogMAR(Logarithm of the Minimum Angle of Resolution)0.9 to -0.3. All of the visual acuity and functional vision testing examinations mentioned above were performed by a single ophthalmologist. The outcomes were recorded as average of three post-operative measurments.
Best Corrected Contrast Sensitivity in Photopic Condition	average data of post-operative 3rd week, 6th week, 12th week measurements	Contrast sensitivity testing was measured with spectacle correction for the target distance of three meters using a wall-mounted FACT sine-wave grating chart with nine levels of contrast (Stereo Optical Inc.)and five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd)) at 250 lux. The last correct grating seen for each spatial frequency is recorded and translated by the "EYEVIEW™ Functional Analysis Software" into a log contrast sensitivity unit. The outcomes were recorded as average of the three post-operative measurements.; ( physiological range of contrast sensitivity: 1.5 cpd : 25\~82.5 ; 3 cpd: 30\~150 ; 6 cpd: 65 \~ 200 ; 12 cpd: 20 \~130 ; 18 cpd: 6.5 \~ 65 )

Secondary Outcome Measures

Name	Time	Method
Corneal High-order Aberrations	pre-op & averate data of post-op 3rd, 6th, 12th week measurements	Corneal topography was performed with a TMS-4 corneal tomographer (Tomey, Japan). We used the 31-rings placido-based system that covers 10.9 mm of corneal diameter which is sufficient for the study of aberrations up to the fifth order for 6 mm diameter. Corneal HOAs were 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 High-order Aberrations	average data of post-op 3rd, 6th, 12th week measurements	A Hartmann-Shack aberrometer (Zywave, Bausch \& Lomb Inc., Rochester, New York ) was used for measurement of HOAs of the whole eye. The measurements were done under maximal mydriasis with Mydrin-P (phenylephrine hydrochloride 0.5% and tropicamide 0.5%, Santen). The wavefront errors were described using the RMS of Zernike polynomials for total HOA at pupil diameters of 5 mm and 6 mm, primary spherical (Z 4,0) and 3rd-to 5th-order aberration at the pupil diameter of 6 mm.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan