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

• ClinicalTrials.gov Identifier: NCT00459303
• Recruitment Status: Completed
• First Posted: April 11, 2007
• Results First Posted: February 17, 2014
• Last Update Posted: February 17, 2014
• Sponsor: National Taiwan University Hospital
• Information provided by (Responsible Party): National Taiwan University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cataract	Device: aspherical intraocular lens; Device: spherical intraocular lens	Phase 4

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intraidivisual Comparison of Functional Vision Provided by AMO Tecnis Z9000 and ALcon SA60AT Acrysof Posterior Chamber Intraocular Lenses
• Study Start Date: October 2005
• Actual Primary Completion Date: September 2007
• Actual Study Completion Date: December 2007

Arms and Interventions

Arm

Intervention/treatment

Active Comparator: 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.

Device: 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); Other Name: AMO Tecnis Z9000; 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); Other Name: Alcon SA60AT Acrysof

Outcome Measures

Primary Outcome Measures :

1. Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition [ Time Frame: 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.
2. Best Corrected Contrast Sensitivity in Photopic Condition [ Time Frame: 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 :

1. Corneal High-order Aberrations [ Time Frame: 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).
2. Total Ocular High-order Aberrations [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Taiwan

National Taiwan University Hospital

Taipei, Taiwan

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

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT00459303
• Other Study ID Numbers: 05012006
• First Posted: April 11, 2007
• Results First Posted: February 17, 2014
• Last Update Posted: February 17, 2014
• Last Verified: December 2013

Keywords provided by National Taiwan University Hospital:

cataract; aspherical intraocular lenses; functional vision

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases