Cataract
Conditions
Keywords
ReSTOR Aspheric +4 IOL
Brief summary
To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons throughout the United States.
Interventions
DEVICEReSTOR
Patients were implanted with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) in one or both eyes for treatment of cataract.
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* operable cataracts; candidate for presbyopic correcting intraocular lens (IOL)
Exclusion criteria
* ocular comorbidities confounding study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 1 week to 10 months | Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by 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 | 1 week to 10 months | Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity. |
Countries
United States
Participant flow
Recruitment details
Subjects 18 years of age and older of either sex and any race. Diagnosis of cataracts in one or both eyes.
Pre-assignment details
Subjects eligibility was determined at the preoperative visit.
Participants by arm
| Arm | Count |
|---|---|
| ReSTOR Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) | 146 |
| Total | 146 |
Baseline characteristics
| Characteristic | ReSTOR |
|---|---|
| Age, Customized <=18 years | 0 participants |
| Age, Customized >=65 years | 59 participants |
| Age, Customized Between 18 and 65 years | 65 participants |
| Sex/Gender, Customized Female | 79 participants |
| Sex/Gender, Customized Male | 54 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Visual Acuity
Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by 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: 1 week to 10 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR | Visual Acuity | Distance (4 meters) UCVA | 0.07 logMAR | Standard Deviation 0.12 |
| ReSTOR | Visual Acuity | Near (preferred distance) UCVA | 0.07 logMAR | Standard Deviation 0.11 |
| ReSTOR | Visual Acuity | Distance (4 meters) BSCVA | 0.02 logMAR | Standard Deviation 0.1 |
| ReSTOR | Visual Acuity | Near (preferred distance) BSCVA | 0.06 logMAR | Standard Deviation 0.11 |
Secondary
Contrast Sensitivity
Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.
Time frame: 1 week to 10 months
Population: contrast sensitivity data was received for only 51 of 146 patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR | Contrast Sensitivity | Mesopic with glare condition at 3 cpd | 1.28 log units | Standard Deviation 0.58 |
| ReSTOR | Contrast Sensitivity | Mesopic with glare condition at 6 cpd | 0.92 log units | Standard Deviation 0.74 |
| ReSTOR | Contrast Sensitivity | Mesopic with glare condition at 12 cpd | 0.27 log units | Standard Deviation 0.57 |
| ReSTOR | Contrast Sensitivity | Mesopic with glare condition at 18 cpd | 0.07 log units | Standard Deviation 0.27 |
| ReSTOR | Contrast Sensitivity | Photopic condition at 1.5 cpd | 1.61 log units | Standard Deviation 0.31 |
| ReSTOR | Contrast Sensitivity | Photopic condition at 3 cpd | 1.78 log units | Standard Deviation 0.32 |
| ReSTOR | Contrast Sensitivity | Photopic condition at 6 cpd | 1.72 log units | Standard Deviation 0.44 |
| ReSTOR | Contrast Sensitivity | Photopic condition at 12 cpd | 1.22 log units | Standard Deviation 0.53 |
| ReSTOR | Contrast Sensitivity | Photopic condition at 18 cpd | 0.70 log units | Standard Deviation 0.57 |
| ReSTOR | Contrast Sensitivity | Mesopic condition at 1.5 cpd | 1.69 log units | Standard Deviation 0.3 |
| ReSTOR | Contrast Sensitivity | Mesopic condition at 3 cpd | 1.69 log units | Standard Deviation 0.32 |
| ReSTOR | Contrast Sensitivity | Mesopic condition at 6 cpd | 1.43 log units | Standard Deviation 0.57 |
| ReSTOR | Contrast Sensitivity | Mesopic condition at 12 cpd | 0.66 log units | Standard Deviation 0.67 |
| ReSTOR | Contrast Sensitivity | Mesopic condition at 18 cpd | 0.25 log units | Standard Deviation 0.45 |
| ReSTOR | Contrast Sensitivity | Mesopic with glare condition at 1.5 cpd | 1.29 log units | Standard Deviation 0.52 |