Trial Outcomes & Findings for Comparison of Functional Vision Provided by AMO Tecnis Z9000 and Alcon SA60AT Acrysof (NCT NCT00459303)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

average data of post-op 3rd, 6th, 12th week measurements

Results posted on

2014-02-17

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Cataract Patients Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cataract Patients n=20 Participants Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age, Continuous	70.4 years STANDARD_DEVIATION 9.34 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment Taiwan	20 participants n=5 Participants

PRIMARY outcome

Timeframe: average data of post-op 3rd, 6th, 12th week measurements

Population: we obtained data and calculated the probable sample size needed from the following reference papers: 1. Ophthalmologe 2005 Jan;102(1):51-7. 2. Acta Ophthalmol Scand 2004;82(6):718-22.

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.

Outcome measures

Outcome measures
Measure	Spherical Intraocular Lens n=20 Participants patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.	Aspherical Intraocular Lens n=20 Participants patients recieved cataract surgery and recived aspherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition	0.34 log MAR Standard Deviation 0.10	0.34 log MAR Standard Deviation 0.10

PRIMARY outcome

Timeframe: 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 )

Outcome measures

Outcome measures
Measure	Spherical Intraocular Lens n=20 Participants patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.	Aspherical Intraocular Lens n=20 Participants patients recieved cataract surgery and recived aspherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
Best Corrected Contrast Sensitivity in Photopic Condition 1.5 cpd	47.03 units on a scale Standard Deviation 13.48	55.90 units on a scale Standard Deviation 20.76
Best Corrected Contrast Sensitivity in Photopic Condition 3 cpd	82.64 units on a scale Standard Deviation 14.78	85.09 units on a scale Standard Deviation 21.76
Best Corrected Contrast Sensitivity in Photopic Condition 6 cpd	69.31 units on a scale Standard Deviation 34.02	72.41 units on a scale Standard Deviation 31.45
Best Corrected Contrast Sensitivity in Photopic Condition 12 cpd	23.47 units on a scale Standard Deviation 17.73	27.45 units on a scale Standard Deviation 22.68
Best Corrected Contrast Sensitivity in Photopic Condition 18 cpd	6.97 units on a scale Standard Deviation 3.99	6.34 units on a scale Standard Deviation 4.51

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Spherical Intraocular Lens n=20 Participants patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.	Aspherical Intraocular Lens n=20 Participants patients recieved cataract surgery and recived aspherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
Corneal High-order Aberrations	0.10 μm Standard Deviation 0.04	0.11 μm Standard Deviation 0.04

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Spherical Intraocular Lens n=20 Participants patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.	Aspherical Intraocular Lens n=20 Participants patients recieved cataract surgery and recived aspherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
Total Ocular High-order Aberrations	0.6314 μm Standard Deviation 0.1342	0.0856 μm Standard Deviation 0.1070

Adverse Events

Cataract Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fung-Rong Hu

National Taiwan University Hospital

Phone: +886223123456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place