Cataract
Conditions
Keywords
cataract, cataract surgery, IOL, intraocular lens, ReSTOR, Replacement of cataract
Brief summary
Randomized, parallel group, subject masked, multi-center six (6) month follow-up study comparing ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 implanted in both eyes to ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.
Interventions
DEVICEACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Intraocular Lens
DEVICEACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
Intraocular Lens
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts * Calculated lens power is within the available range * Willing and able to complete all required postoperative visits * Planned cataract removal by phacoemulsification and/or liquifacture * Potential postoperative visual acuity of 0.2 logMAR or better in study eyes * Preoperative astigmatism of 1.0 Diopter (D) or less, measured by keratometry in study eyes * Clear intraocular media other than cataract in study eyes * Able to comprehend and sign a statement of informed consent * Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR, or if BCDVA is equal to or better than 0.2 logMAR, BCDVA with a Brightness Acuity Tester (BAT) on Medium setting must be worse than 0.2 logMAR Exclusion: * Significant irregular corneal aberration as demonstrated by corneal topography * Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR * Subjects who may reasonably be expected to require laser treatments at any time * Previous corneal refractive surgery * Amblyopia * Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy) * Diabetic retinopathy * Extremely shallow anterior chamber, not due to swollen cataract * Microphthalmos * Previous retinal detachment * Previous corneal transplant * Recurrent severe anterior or posterior segment inflammation of unknown etiology * Rubella or traumatic cataract * Iris neovascularization * Glaucoma (uncontrolled or controlled with medication) * Aniridia * Optic nerve atrophy * Pregnancy * Current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g.Flomax® (tamsulosin HCL), Hytrin®, or Cardura®) * Any subject currently participating in another investigational drug or device study that may confound the results of this investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) | 3 months | Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Distance Corrected Distance Visual Acuity | 3 months post-operative | Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). |
| Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm) | 3 months post-operative | Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). |
| Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm) | 3 months post-operative | Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). |
| Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm) | 3 months post-operative | Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). |
Countries
United States
Participant flow
Recruitment details
Only adult subjects of either gender or any race in need of cataract extraction in both eyes were considered for enrollment. 280 subjects were implanted bilaterally with either the ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 or the ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 based upon a 1:1 randomization.
Pre-assignment details
Subjects were examined to ensure inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study were enrolled. Subject numbers were assigned after obtaining consent meeting inclusion/exclusion criteria. Subjects were considered enrolled once implanted in the first operative eye.
Participants by arm
| Arm | Count |
|---|---|
| ACRYSOF® ReSTOR® +3.0 ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens | 141 |
| ACRYSOF® ReSTOR® Aspheric +4.0 ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens | 139 |
| Total | 280 |
Baseline characteristics
| Characteristic | ACRYSOF® ReSTOR® +3.0 | ACRYSOF® ReSTOR® Aspheric +4.0 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 90 Participants | 99 Participants | 189 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 40 Participants | 91 Participants |
| Sex: Female, Male Female | 95 Participants | 97 Participants | 192 Participants |
| Sex: Female, Male Male | 46 Participants | 42 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 153 | 0 / 147 | 0 / 151 | 0 / 143 |
| serious Total, serious adverse events | 6 / 153 | 2 / 147 | 2 / 151 | 3 / 143 |
Outcome results
Primary
Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.
Time frame: 3 months
Population: Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACRYSOF® ReSTOR® +3.0 | Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) | 0.07 logMAR |
| ACRYSOF® ReSTOR® Aspheric +4.0 | Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) | 0.09 logMAR |
Secondary
Binocular Distance Corrected Distance Visual Acuity
Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time frame: 3 months post-operative
Population: Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACRYSOF® ReSTOR® +3.0 | Binocular Distance Corrected Distance Visual Acuity | -0.05 logMAR |
| ACRYSOF® ReSTOR® Aspheric +4.0 | Binocular Distance Corrected Distance Visual Acuity | -0.05 logMAR |
Secondary
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)
Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time frame: 3 months post-operative
Population: Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACRYSOF® ReSTOR® +3.0 | Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm) | 0.06 logMAR |
| ACRYSOF® ReSTOR® Aspheric +4.0 | Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm) | 0.24 logMAR |
Secondary
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)
Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time frame: 3 months post-operative
Population: Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACRYSOF® ReSTOR® +3.0 | Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm) | 0.12 logMAR |
| ACRYSOF® ReSTOR® Aspheric +4.0 | Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm) | 0.32 logMAR |
Secondary
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)
Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time frame: 3 months post-operative
Population: Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACRYSOF® ReSTOR® +3.0 | Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm) | 0.18 logMAR |
| ACRYSOF® ReSTOR® Aspheric +4.0 | Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm) | 0.34 logMAR |