Cataract
Conditions
Keywords
Cataract IOL ReSTOR Aspheric, Bilateral cataract
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 Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.
Interventions
DEVICEAcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3
Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, AcrySof ReSTOR +4 IOL in the other eye 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 Near, Intermediate and Distance | 6 months after surgery | Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), 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. Scores were calculated using logMAR values. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA. |
Countries
Canada
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| ReSTOR Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | ReSTOR |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Gender Female | 24 participants |
| Gender Male | 25 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 50 |
| serious Total, serious adverse events | 1 / 50 |
Outcome results
Primary
Binocular Visual Acuity at Near, Intermediate and Distance
Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), 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. Scores were calculated using logMAR values. 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 | Binocular Visual Acuity at Near, Intermediate and Distance | Best corrected best near VA (34.17 cm +/- 4.40 cm) | -0.01 LogMAR | Standard Deviation 0.1 |
| ReSTOR | Binocular Visual Acuity at Near, Intermediate and Distance | Uncorrected distance VA (4 m) | 0.02 LogMAR | Standard Deviation 0.08 |
| ReSTOR | Binocular Visual Acuity at Near, Intermediate and Distance | Uncorrected intermediate VA (60 cm) | 0.31 LogMAR | Standard Deviation 0.11 |
| ReSTOR | Binocular Visual Acuity at Near, Intermediate and Distance | Uncorrected best near VA (34.11 cm +/- 4.23 cm) | -0.02 LogMAR | Standard Deviation 0.1 |
| ReSTOR | Binocular Visual Acuity at Near, Intermediate and Distance | Best corrected distance VA (4 m) | -0.04 LogMAR | Standard Deviation 0.07 |
| ReSTOR | Binocular Visual Acuity at Near, Intermediate and Distance | Best corrected intermediate VA (60 cm) | 0.31 LogMAR | Standard Deviation 0.15 |