Cataracts
Conditions
Keywords
Cataract, visual acuity, AcrySof ReSTOR Aspheric Intraoculare Lens, Bilateral cataract
Brief summary
The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).
Interventions
DEVICEAcrySof ReSTOR Aspheric IOL
Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation. * 50\ 75 years of age * \<1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.
Exclusion criteria
* Patients with pre-existing conditions that could skew the results. * Any of conditions before and during surgery specified in the product information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected and Best Corrected Visual Acuities (Near and Distance) | 6 Months Following Cataract Surgery | Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. 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
34 eligible patients were enrolled into the study
Pre-assignment details
Open-label, single arm, non-randomized
Participants by arm
| Arm | Count |
|---|---|
| ReSTOR Aspheric Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | ReSTOR Aspheric |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Uncorrected and Best Corrected Visual Acuities (Near and Distance)
Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. 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 Following Cataract Surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR Aspheric | Uncorrected and Best Corrected Visual Acuities (Near and Distance) | Near Uncorrected Visual Acuity | 0.02 logMAR | Standard Deviation 0.08 |
| ReSTOR Aspheric | Uncorrected and Best Corrected Visual Acuities (Near and Distance) | Near Best-Corrected Visual Acuity | 0.01 logMAR | Standard Deviation 0.07 |
| ReSTOR Aspheric | Uncorrected and Best Corrected Visual Acuities (Near and Distance) | Distance Uncorrected Visual Acuity | 0.00 logMAR | Standard Deviation 0.07 |
| ReSTOR Aspheric | Uncorrected and Best Corrected Visual Acuities (Near and Distance) | Distance Best-Corrected Visual Acuity | -0.03 logMAR | Standard Deviation 0.07 |