Cataract
Conditions
Keywords
Bilateral Cataract, IOL, ReSTOR, Aspheric
Brief summary
The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).
Interventions
DEVICEAcrySof ReSTOR Aspheric IOL model SN6AD1
Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL) following cataract removal.
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.
Exclusion criteria
* Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under Precautions for subject groups that should be excluded from this study. All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Visual Acuity at Distance, Near and Intermediate | 6 months after surgery | Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ReSTOR +3 Multifocal Lens Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL) | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | ReSTOR +3 Multifocal Lens |
|---|---|
| Age Continuous | 74.5 years STANDARD_DEVIATION 6.44 |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 16 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
Binocular Visual Acuity at Distance, Near and Intermediate
Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA.
Time frame: 6 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR +3 Multifocal Lens | Binocular Visual Acuity at Distance, Near and Intermediate | Uncorrected VA at 4 m | 0.00 LogMAR | Standard Deviation 0.08 |
| ReSTOR +3 Multifocal Lens | Binocular Visual Acuity at Distance, Near and Intermediate | Uncorrected VA at 60 cm | 0.13 LogMAR | Standard Deviation 0.11 |
| ReSTOR +3 Multifocal Lens | Binocular Visual Acuity at Distance, Near and Intermediate | Uncorrected VA best near (39.69 cm +/- 4.09 cm) | 0.07 LogMAR | Standard Deviation 0.08 |
| ReSTOR +3 Multifocal Lens | Binocular Visual Acuity at Distance, Near and Intermediate | Best Corrected VA at 4 m | 0.00 LogMAR | Standard Deviation 0.06 |
| ReSTOR +3 Multifocal Lens | Binocular Visual Acuity at Distance, Near and Intermediate | Best Corrected VA at 60 cm | 0.09 LogMAR | Standard Deviation 0.11 |
| ReSTOR +3 Multifocal Lens | Binocular Visual Acuity at Distance, Near and Intermediate | Best Corrected VA best near (41.31 cm +/- 5.82 cm) | 0.07 LogMAR | Standard Deviation 0.08 |