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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00459303
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 26
• Patients Per Site Per Month: 0.8

Study Details

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
• 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: Oct 1, 2005
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Dec 1, 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 Names: 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 Names: Alcon SA60AT Acrysof

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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).

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT00459303
• Other Study ID Numbers: 05012006
• First Posted: Apr 11, 2007
• Last Update Posted: Feb 17, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by National Taiwan University Hospital: cataract; aspherical intraocular lenses; functional vision
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye. All cases were enrolled from October 2005 to April 2006 and were followed up for at least three months at the department of ophthalmology.
Pre-assignment Detail	Patients with diabetes or other systemic disease, such as dysthyroid related orbitopathy or drug related optic neuropathy, that may potentially affect contrast sensitivity and visual quality were excluded.

Arm/Group Title	Cataract Patients
Arm/Group Description	Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cataract Patients
Arm/Group Description	Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 25%
>=65 years	15 75%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.4 (9.34)
Sex: Female, Male (Count of Participants)
Female	11 55%
Male	9 45%
Region of Enrollment (participants) [Number]
Taiwan	20 100%

Outcome Measures

1. Primary Outcome

Title	Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition
Description	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.
Time Frame	average data of post-op 3rd, 6th, 12th week measurements

Outcome Measure Data

Analysis Population Description

we obtained data and calculated the probable sample size needed from the following reference papers: Ophthalmologe 2005 Jan;102(1):51-7. Acta Ophthalmol Scand 2004;82(6):718-22.

Arm/Group Title	Spherical Intraocular Lens	Aspherical Intraocular Lens
Arm/Group Description	patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.	patients recieved cataract surgery and recived aspherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
Measure Participants	20	20
Mean (Standard Deviation) [log MAR]	0.34 (0.10)	0.34 (0.10)

2. Secondary Outcome

Title	Corneal High-order Aberrations
Description	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).
Time Frame	pre-op & averate data of post-op 3rd, 6th, 12th week measurements

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spherical Intraocular Lens	Aspherical Intraocular Lens
Arm/Group Description	patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.	patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
Measure Participants	20	20
Mean (Standard Deviation) [μm]	0.10 (0.04)	0.11 (0.04)

3. Secondary Outcome

Title	Total Ocular High-order Aberrations
Description	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.
Time Frame	average data of post-op 3rd, 6th, 12th week measurements

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spherical Intraocular Lens	Aspherical Intraocular Lens
Arm/Group Description	patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.	patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
Measure Participants	20	20
Mean (Standard Deviation) [μm]	0.6314 (0.1342)	0.0856 (0.1070)

4. Primary Outcome

Title	Best Corrected Contrast Sensitivity in Photopic Condition
Description	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 )
Time Frame	average data of post-operative 3rd week, 6th week, 12th week measurements

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spherical Intraocular Lens	Aspheric Intraocular Lens
Arm/Group Description	patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.	patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
Measure Participants	20	20
1.5 cpd	47.03 (13.48)	55.90 (20.76)
3 cpd	82.64 (14.78)	85.09 (21.76)
6 cpd	69.31 (34.02)	72.41 (31.45)
12 cpd	23.47 (17.73)	27.45 (22.68)
18 cpd	6.97 (3.99)	6.34 (4.51)

Adverse Events

Arm/Group Title	Cataract Patients
Arm/Group Description	Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
All Cause Mortality
	Cataract Patients
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cataract Patients
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Cataract Patients
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

small sample size

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.