Cataract
Conditions
Keywords
ReSTOR
Brief summary
This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL
Interventions
DEVICEReSTOR
Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)
DEVICETecnis
Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)
DEVICEAcri.LISA
Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosed with cataracts
Exclusion criteria
* Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Sensitivity | 6 months | Contrast 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. |
| Defocus Curve | 6 months post-operative | Defocus 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Subject eligibility was determined at the pre-operative visit.
Participants by arm
| Arm | Count |
|---|---|
| ReSTOR Aspheric +4 Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3 | 20 |
| Acri LISA IOL Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D | 22 |
| Total | 42 |
Baseline characteristics
| Characteristic | ReSTOR Aspheric +4 | Acri LISA IOL | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 1 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 21 Participants | 33 Participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 22 |
| serious Total, serious adverse events | 0 / 20 | 0 / 22 |
Outcome results
Primary
Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR Aspheric +4 | Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate | UCVA 80 cm | 0.20 logMAR | Standard Deviation 0.14 |
| ReSTOR Aspheric +4 | Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate | UCVA 4 m | 0.02 logMAR | Standard Deviation 0.13 |
| ReSTOR Aspheric +4 | Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate | UCVA 60 cm | 0.21 logMAR | Standard Deviation 0.14 |
| ReSTOR Aspheric +4 | Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate | UCVA Near at 40 cm | -0.04 logMAR | Standard Deviation 0.18 |
| Acri LISA IOL | Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate | UCVA Near at 40 cm | -0.05 logMAR | Standard Deviation 0.07 |
| Acri LISA IOL | Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate | UCVA 60 cm | 0.19 logMAR | Standard Deviation 0.14 |
| Acri LISA IOL | Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate | UCVA 4 m | 0.01 logMAR | Standard Deviation 0.18 |
| Acri LISA IOL | Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate | UCVA 80 cm | 0.20 logMAR | Standard Deviation 0.15 |
Secondary
Contrast Sensitivity
Contrast 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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR Aspheric +4 | Contrast Sensitivity | Contrast Sensitivity 18 cpd | 1.02 log units | Standard Deviation 0.42 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Mesopic Conditions, 12 cpd | 1.11 log units | Standard Deviation 0.36 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Contrast Sensitivity 3 cpd | 1.98 log units | Standard Deviation 0.23 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Mesopic Conditions, 18 cpd | 0.54 log units | Standard Deviation 0.26 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Mesopic Conditions, 1.5 cpd | 1.87 log units | Standard Deviation 0.21 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Mesopic Conditions w/glare, 1.5 cpd | 1.56 log units | Standard Deviation 0.37 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Mesopic Conditions w/glare, 6 cpd | 1.31 log units | Standard Deviation 0.34 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Contrast Sensitivity 12 cpd | 1.57 log units | Standard Deviation 0.31 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Mesopic Conditions, 3 cpd | 1.91 log units | Standard Deviation 0.22 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Mesopic Conditions w/glare, 3 cpd | 1.56 log units | Standard Deviation 0.39 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Contrast Sensitivity 6 cpd | 1.94 log units | Standard Deviation 0.24 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Mesopic Conditions w/glare, 12 cpd | 0.72 log units | Standard Deviation 0.26 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Mesopic Conditions, 6 cpd | 1.68 log units | Standard Deviation 0.23 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Mesopic Conditions w/glare, 18 cpd | 0.34 log units | Standard Deviation 0.13 |
| ReSTOR Aspheric +4 | Contrast Sensitivity | Contrast Sensitivity 1.5 cpd (cycles per degree) | 1.88 log units | Standard Deviation 0.2 |
| Acri LISA IOL | Contrast Sensitivity | Mesopic Conditions w/glare, 18 cpd | 0.30 log units | Standard Deviation 0 |
| Acri LISA IOL | Contrast Sensitivity | Contrast Sensitivity 1.5 cpd (cycles per degree) | 1.78 log units | Standard Deviation 0.27 |
| Acri LISA IOL | Contrast Sensitivity | Contrast Sensitivity 3 cpd | 2.01 log units | Standard Deviation 0.15 |
| Acri LISA IOL | Contrast Sensitivity | Contrast Sensitivity 6 cpd | 1.99 log units | Standard Deviation 0.16 |
| Acri LISA IOL | Contrast Sensitivity | Contrast Sensitivity 12 cpd | 1.53 log units | Standard Deviation 0.22 |
| Acri LISA IOL | Contrast Sensitivity | Contrast Sensitivity 18 cpd | 1.07 log units | Standard Deviation 0.3 |
| Acri LISA IOL | Contrast Sensitivity | Mesopic Conditions, 1.5 cpd | 1.83 log units | Standard Deviation 0.15 |
| Acri LISA IOL | Contrast Sensitivity | Mesopic Conditions, 3 cpd | 1.83 log units | Standard Deviation 0.16 |
| Acri LISA IOL | Contrast Sensitivity | Mesopic Conditions, 6 cpd | 1.62 log units | Standard Deviation 0.25 |
| Acri LISA IOL | Contrast Sensitivity | Mesopic Conditions, 12 cpd | 1.16 log units | Standard Deviation 0.36 |
| Acri LISA IOL | Contrast Sensitivity | Mesopic Conditions, 18 cpd | 0.52 log units | Standard Deviation 0.22 |
| Acri LISA IOL | Contrast Sensitivity | Mesopic Conditions w/glare, 6 cpd | 1.26 log units | Standard Deviation 0.24 |
| Acri LISA IOL | Contrast Sensitivity | Mesopic Conditions w/glare, 1.5 cpd | 1.55 log units | Standard Deviation 0.31 |
| Acri LISA IOL | Contrast Sensitivity | Mesopic Conditions w/glare, 3 cpd | 1.52 log units | Standard Deviation 0.24 |
| Acri LISA IOL | Contrast Sensitivity | Mesopic Conditions w/glare, 12 cpd | 0.73 log units | Standard Deviation 0.19 |
Secondary
Defocus Curve
Defocus 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.
Time frame: 6 months post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR Aspheric +4 | Defocus Curve | Negative Defocus Curve, -4.0 Diopter | 0.24 logMAR | Standard Deviation 0.14 |
| ReSTOR Aspheric +4 | Defocus Curve | Negative Defocus Curve, -3.0 Diopter | 0.0 logMAR | Standard Deviation 0.08 |
| ReSTOR Aspheric +4 | Defocus Curve | Negative Defocus Curve, -0.5 Diopter | 0.06 logMAR | Standard Deviation 0.11 |
| ReSTOR Aspheric +4 | Defocus Curve | Negative Defocus Curve, -4.5 Diopter | 0.38 logMAR | Standard Deviation 0.1 |
| ReSTOR Aspheric +4 | Defocus Curve | Negative Defocus Curve, 0.0 Diopter | -0.08 logMAR | Standard Deviation 0.07 |
| ReSTOR Aspheric +4 | Defocus Curve | Negative Defocus Curve, -2.5 Diopter | 0.09 logMAR | Standard Deviation 0.12 |
| ReSTOR Aspheric +4 | Defocus Curve | Positive Defocus Curve, 2.0 Diopter | 0.61 logMAR | Standard Deviation 0.11 |
| ReSTOR Aspheric +4 | Defocus Curve | Negative Defocus Curve, -1.0 Diopter | 0.21 logMAR | Standard Deviation 0.14 |
| ReSTOR Aspheric +4 | Defocus Curve | Positive Defocus Curve, 1.5 Diopter | 0.45 logMAR | Standard Deviation 0.13 |
| ReSTOR Aspheric +4 | Defocus Curve | Negative Defocus Curve, -2.0 Diopter | 0.29 logMAR | Standard Deviation 0.13 |
| ReSTOR Aspheric +4 | Defocus Curve | Positive Defocus Curve, 1.0 Diopter | 0.26 logMAR | Standard Deviation 0.13 |
| ReSTOR Aspheric +4 | Defocus Curve | Negative Defocus Curve, -3.5 Diopter | 0.08 logMAR | Standard Deviation 0.08 |
| ReSTOR Aspheric +4 | Defocus Curve | Positive Defocus Curve, 0.5 Diopter | 0.03 logMAR | Standard Deviation 0.11 |
| ReSTOR Aspheric +4 | Defocus Curve | Negative Defocus Curve, -1.5 Diopter | 0.31 logMAR | Standard Deviation 0.15 |
| ReSTOR Aspheric +4 | Defocus Curve | Positive Defocus Curve, 0.0 Diopter | -0.08 logMAR | Standard Deviation 0.08 |
| ReSTOR Aspheric +4 | Defocus Curve | Negative Defocus Curve, -5.0 Diopter | 0.55 logMAR | Standard Deviation 0.13 |
| Acri LISA IOL | Defocus Curve | Positive Defocus Curve, 0.0 Diopter | -0.09 logMAR | Standard Deviation 0.08 |
| Acri LISA IOL | Defocus Curve | Negative Defocus Curve, -5.0 Diopter | 0.58 logMAR | Standard Deviation 0.12 |
| Acri LISA IOL | Defocus Curve | Negative Defocus Curve, -4.5 Diopter | 0.42 logMAR | Standard Deviation 0.13 |
| Acri LISA IOL | Defocus Curve | Negative Defocus Curve, -4.0 Diopter | 0.27 logMAR | Standard Deviation 0.12 |
| Acri LISA IOL | Defocus Curve | Negative Defocus Curve, -3.5 Diopter | 0.08 logMAR | Standard Deviation 0.11 |
| Acri LISA IOL | Defocus Curve | Negative Defocus Curve, -3.0 Diopter | 0.02 logMAR | Standard Deviation 0.09 |
| Acri LISA IOL | Defocus Curve | Negative Defocus Curve, -2.5 Diopter | 0.08 logMAR | Standard Deviation 0.11 |
| Acri LISA IOL | Defocus Curve | Negative Defocus Curve, -2.0 Diopter | 0.27 logMAR | Standard Deviation 0.16 |
| Acri LISA IOL | Defocus Curve | Negative Defocus Curve, -1.5 Diopter | 0.32 logMAR | Standard Deviation 0.14 |
| Acri LISA IOL | Defocus Curve | Negative Defocus Curve, -1.0 Diopter | 0.17 logMAR | Standard Deviation 0.12 |
| Acri LISA IOL | Defocus Curve | Negative Defocus Curve, -0.5 Diopter | 0.02 logMAR | Standard Deviation 0.1 |
| Acri LISA IOL | Defocus Curve | Negative Defocus Curve, 0.0 Diopter | -0.10 logMAR | Standard Deviation 0.08 |
| Acri LISA IOL | Defocus Curve | Positive Defocus Curve, 2.0 Diopter | 0.57 logMAR | Standard Deviation 0.13 |
| Acri LISA IOL | Defocus Curve | Positive Defocus Curve, 1.5 Diopter | 0.44 logMAR | Standard Deviation 0.12 |
| Acri LISA IOL | Defocus Curve | Positive Defocus Curve, 1.0 Diopter | 0.27 logMAR | Standard Deviation 0.12 |
| Acri LISA IOL | Defocus Curve | Positive Defocus Curve, 0.5 Diopter | 0.02 logMAR | Standard Deviation 0.13 |