Trial Outcomes & Findings for Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA (NCT NCT00721253)
NCT ID: NCT00721253
Last Updated: 2010-03-16
Results Overview
Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
6 months
Results posted on
2010-03-16
Participant Flow
Subjects 18 years or older of either sex and any race; bilateral diagnosis of cataracts. There were no patients that received implantation of the Tecnis Multifocal lens.
Subject eligibility was determined at the pre-operative visit.
Participant milestones
| Measure |
ReSTOR Aspheric +4
Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
|
Acri LISA IOL
Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
|
Tecnis MF
Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
0
|
|
Overall Study
COMPLETED
|
20
|
22
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA
Baseline characteristics by cohort
| Measure |
ReSTOR Aspheric +4
n=20 Participants
Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
|
Acri LISA IOL
n=22 Participants
Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsUncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.
Outcome measures
| Measure |
ReSTOR Aspheric +4
n=20 Participants
Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
|
Acri LISA IOL
n=22 Participants
Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
|
|---|---|---|
|
Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate
UCVA 4 m
|
0.02 logMAR
Standard Deviation 0.13
|
0.01 logMAR
Standard Deviation 0.18
|
|
Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate
UCVA 80 cm
|
0.20 logMAR
Standard Deviation 0.14
|
0.20 logMAR
Standard Deviation 0.15
|
|
Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate
UCVA 60 cm
|
0.21 logMAR
Standard Deviation 0.14
|
0.19 logMAR
Standard Deviation 0.14
|
|
Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate
UCVA Near at 40 cm
|
-0.04 logMAR
Standard Deviation 0.18
|
-0.05 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 6 monthsContrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
Outcome measures
| Measure |
ReSTOR Aspheric +4
n=20 Participants
Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
|
Acri LISA IOL
n=22 Participants
Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
|
|---|---|---|
|
Contrast Sensitivity
Contrast Sensitivity 1.5 cpd (cycles per degree)
|
1.88 log units
Standard Deviation 0.20
|
1.78 log units
Standard Deviation 0.27
|
|
Contrast Sensitivity
Contrast Sensitivity 3 cpd
|
1.98 log units
Standard Deviation 0.23
|
2.01 log units
Standard Deviation 0.15
|
|
Contrast Sensitivity
Contrast Sensitivity 6 cpd
|
1.94 log units
Standard Deviation 0.24
|
1.99 log units
Standard Deviation 0.16
|
|
Contrast Sensitivity
Contrast Sensitivity 12 cpd
|
1.57 log units
Standard Deviation 0.31
|
1.53 log units
Standard Deviation 0.22
|
|
Contrast Sensitivity
Contrast Sensitivity 18 cpd
|
1.02 log units
Standard Deviation 0.42
|
1.07 log units
Standard Deviation 0.30
|
|
Contrast Sensitivity
Mesopic Conditions, 1.5 cpd
|
1.87 log units
Standard Deviation 0.21
|
1.83 log units
Standard Deviation 0.15
|
|
Contrast Sensitivity
Mesopic Conditions, 3 cpd
|
1.91 log units
Standard Deviation 0.22
|
1.83 log units
Standard Deviation 0.16
|
|
Contrast Sensitivity
Mesopic Conditions, 6 cpd
|
1.68 log units
Standard Deviation 0.23
|
1.62 log units
Standard Deviation 0.25
|
|
Contrast Sensitivity
Mesopic Conditions, 12 cpd
|
1.11 log units
Standard Deviation 0.36
|
1.16 log units
Standard Deviation 0.36
|
|
Contrast Sensitivity
Mesopic Conditions, 18 cpd
|
0.54 log units
Standard Deviation 0.26
|
0.52 log units
Standard Deviation 0.22
|
|
Contrast Sensitivity
Mesopic Conditions w/glare, 1.5 cpd
|
1.56 log units
Standard Deviation 0.37
|
1.55 log units
Standard Deviation 0.31
|
|
Contrast Sensitivity
Mesopic Conditions w/glare, 3 cpd
|
1.56 log units
Standard Deviation 0.39
|
1.52 log units
Standard Deviation 0.24
|
|
Contrast Sensitivity
Mesopic Conditions w/glare, 6 cpd
|
1.31 log units
Standard Deviation 0.34
|
1.26 log units
Standard Deviation 0.24
|
|
Contrast Sensitivity
Mesopic Conditions w/glare, 12 cpd
|
0.72 log units
Standard Deviation 0.26
|
0.73 log units
Standard Deviation 0.19
|
|
Contrast Sensitivity
Mesopic Conditions w/glare, 18 cpd
|
0.34 log units
Standard Deviation 0.13
|
0.30 log units
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 6 months post-operativeDefocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Outcome measures
| Measure |
ReSTOR Aspheric +4
n=20 Participants
Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
|
Acri LISA IOL
n=22 Participants
Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
|
|---|---|---|
|
Defocus Curve
Negative Defocus Curve, -2.0 Diopter
|
0.29 logMAR
Standard Deviation 0.13
|
0.27 logMAR
Standard Deviation 0.16
|
|
Defocus Curve
Negative Defocus Curve, -1.5 Diopter
|
0.31 logMAR
Standard Deviation 0.15
|
0.32 logMAR
Standard Deviation 0.14
|
|
Defocus Curve
Negative Defocus Curve, -1.0 Diopter
|
0.21 logMAR
Standard Deviation 0.14
|
0.17 logMAR
Standard Deviation 0.12
|
|
Defocus Curve
Negative Defocus Curve, -0.5 Diopter
|
0.06 logMAR
Standard Deviation 0.11
|
0.02 logMAR
Standard Deviation 0.10
|
|
Defocus Curve
Negative Defocus Curve, 0.0 Diopter
|
-0.08 logMAR
Standard Deviation 0.07
|
-0.10 logMAR
Standard Deviation 0.08
|
|
Defocus Curve
Positive Defocus Curve, 2.0 Diopter
|
0.61 logMAR
Standard Deviation 0.11
|
0.57 logMAR
Standard Deviation 0.13
|
|
Defocus Curve
Positive Defocus Curve, 1.5 Diopter
|
0.45 logMAR
Standard Deviation 0.13
|
0.44 logMAR
Standard Deviation 0.12
|
|
Defocus Curve
Positive Defocus Curve, 1.0 Diopter
|
0.26 logMAR
Standard Deviation 0.13
|
0.27 logMAR
Standard Deviation 0.12
|
|
Defocus Curve
Positive Defocus Curve, 0.5 Diopter
|
0.03 logMAR
Standard Deviation 0.11
|
0.02 logMAR
Standard Deviation 0.13
|
|
Defocus Curve
Positive Defocus Curve, 0.0 Diopter
|
-0.08 logMAR
Standard Deviation 0.08
|
-0.09 logMAR
Standard Deviation 0.08
|
|
Defocus Curve
Negative Defocus Curve, -5.0 Diopter
|
0.55 logMAR
Standard Deviation 0.13
|
0.58 logMAR
Standard Deviation 0.12
|
|
Defocus Curve
Negative Defocus Curve, -4.5 Diopter
|
0.38 logMAR
Standard Deviation 0.10
|
0.42 logMAR
Standard Deviation 0.13
|
|
Defocus Curve
Negative Defocus Curve, -4.0 Diopter
|
0.24 logMAR
Standard Deviation 0.14
|
0.27 logMAR
Standard Deviation 0.12
|
|
Defocus Curve
Negative Defocus Curve, -3.5 Diopter
|
0.08 logMAR
Standard Deviation 0.08
|
0.08 logMAR
Standard Deviation 0.11
|
|
Defocus Curve
Negative Defocus Curve, -3.0 Diopter
|
0.0 logMAR
Standard Deviation 0.08
|
0.02 logMAR
Standard Deviation 0.09
|
|
Defocus Curve
Negative Defocus Curve, -2.5 Diopter
|
0.09 logMAR
Standard Deviation 0.12
|
0.08 logMAR
Standard Deviation 0.11
|
Adverse Events
ReSTOR Aspheric +4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acri LISA IOL
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
Results disclosure agreements
- Principal investigator is a sponsor employee No paper that incorporates Sponsor Condfidential information will be submitted for publication without Sponsor's prior written agreement.
- Publication restrictions are in place
Restriction type: OTHER