Cataracts
Conditions
Keywords
AcrySof, ReSTOR, Multifocal, Intraocular Lens
Brief summary
Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.
Interventions
DEVICEReSTOR
AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unilateral operable cataract * Candidate for presbyopic intraocular lens (IOL)
Exclusion criteria
* Ocular comorbidities compromising primary outcome * Bilateral cataracts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 6 months | Uncorrected 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Sensitivity | 6 Months | Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity. |
| Patient Satisfaction | 6 Months Postoperative | Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied). |
| Spectacle Independence | 6 Months | The percentage of patients reporting spectacle independence (no longer needing to wear glasses). |
Countries
United States
Participant flow
Recruitment details
This is a retrospective study that required patients with unilateral implantation of the AcrySof ReSTOR Intraocular Lens (IOL). Patients were to be free of conditions or ocular co-morbidities that may affect visual acuity.
Pre-assignment details
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. This study was not randomized.
Participants by arm
| Arm | Count |
|---|---|
| Monofocal Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye | 20 |
| Phakic Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending | 32 |
| Total | 52 |
Baseline characteristics
| Characteristic | Monofocal | Phakic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 9 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 23 Participants | 31 Participants |
| Sex: Female, Male Female | 9 Participants | 13 Participants | 22 Participants |
| Sex: Female, Male Male | 11 Participants | 19 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 32 |
| serious Total, serious adverse events | 0 / 20 | 0 / 32 |
Outcome results
Primary
Visual Acuity
Uncorrected 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monofocal | Visual Acuity | Distance | -0.04 LogMar | Standard Deviation 0.09 |
| Monofocal | Visual Acuity | Intermediate | 0.14 LogMar | Standard Deviation 0.13 |
| Monofocal | Visual Acuity | Near (Preferred Distance) | 0.04 LogMar | Standard Deviation 0.1 |
| Phakic | Visual Acuity | Distance | -0.01 LogMar | Standard Deviation 0.09 |
| Phakic | Visual Acuity | Intermediate | 0.18 LogMar | Standard Deviation 0.15 |
| Phakic | Visual Acuity | Near (Preferred Distance) | 0.09 LogMar | Standard Deviation 0.12 |
Secondary
Contrast Sensitivity
Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
Time frame: 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monofocal | Contrast Sensitivity | Photopic CS, 3 cycles per degree (cpd) | 1.95 Log Units | Standard Deviation 0.13 |
| Monofocal | Contrast Sensitivity | Mesopic CS, 3 cpd | 1.85 Log Units | Standard Deviation 0.18 |
| Monofocal | Contrast Sensitivity | Mesopic w/Glare CS, 3 cpd | 1.82 Log Units | Standard Deviation 0.18 |
| Monofocal | Contrast Sensitivity | Photopic CS, 6 cpd | 2.10 Log Units | Standard Deviation 0.24 |
| Monofocal | Contrast Sensitivity | Mesopic CS, 6 cpd | 1.76 Log Units | Standard Deviation 0.36 |
| Monofocal | Contrast Sensitivity | Mesopic w/Glare CS, 6 cpd | 1.73 Log Units | Standard Deviation 0.23 |
| Monofocal | Contrast Sensitivity | Photopic CS, 12 cpd | 1.78 Log Units | Standard Deviation 0.26 |
| Monofocal | Contrast Sensitivity | Mesopic CS, 12 cpd | 1.18 Log Units | Standard Deviation 0.51 |
| Monofocal | Contrast Sensitivity | Mesopic w/Glare CS, 12 cpd | 1.21 Log Units | Standard Deviation 0.38 |
| Monofocal | Contrast Sensitivity | Photopic CS, 18 cpd | 1.18 Log Units | Standard Deviation 0.39 |
| Monofocal | Contrast Sensitivity | Mesopic CS, 18 cpd | 0.61 Log Units | Standard Deviation 0.52 |
| Monofocal | Contrast Sensitivity | Mesopic w/Glare CS, 18 cpd | 0.57 Log Units | Standard Deviation 0.41 |
| Phakic | Contrast Sensitivity | Mesopic CS, 18 cpd | 0.49 Log Units | Standard Deviation 0.58 |
| Phakic | Contrast Sensitivity | Photopic CS, 3 cycles per degree (cpd) | 1.90 Log Units | Standard Deviation 0.13 |
| Phakic | Contrast Sensitivity | Photopic CS, 12 cpd | 1.66 Log Units | Standard Deviation 0.27 |
| Phakic | Contrast Sensitivity | Mesopic CS, 3 cpd | 1.84 Log Units | Standard Deviation 0.19 |
| Phakic | Contrast Sensitivity | Photopic CS, 18 cpd | 1.14 Log Units | Standard Deviation 0.31 |
| Phakic | Contrast Sensitivity | Mesopic w/Glare CS, 3 cpd | 1.81 Log Units | Standard Deviation 0.22 |
| Phakic | Contrast Sensitivity | Mesopic CS, 12 cpd | 0.95 Log Units | Standard Deviation 0.51 |
| Phakic | Contrast Sensitivity | Photopic CS, 6 cpd | 2.05 Log Units | Standard Deviation 0.2 |
| Phakic | Contrast Sensitivity | Mesopic w/Glare CS, 18 cpd | 0.40 Log Units | Standard Deviation 0.52 |
| Phakic | Contrast Sensitivity | Mesopic CS, 6 cpd | 1.62 Log Units | Standard Deviation 0.39 |
| Phakic | Contrast Sensitivity | Mesopic w/Glare CS, 12 cpd | 0.88 Log Units | Standard Deviation 0.54 |
| Phakic | Contrast Sensitivity | Mesopic w/Glare CS, 6 cpd | 1.57 Log Units | Standard Deviation 0.56 |
Secondary
Patient Satisfaction
Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).
Time frame: 6 Months Postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monofocal | Patient Satisfaction | 6.85 Units on a Scale | Standard Deviation 2.41 |
| Phakic | Patient Satisfaction | 7.63 Units on a Scale | Standard Deviation 2.24 |
Secondary
Spectacle Independence
The percentage of patients reporting spectacle independence (no longer needing to wear glasses).
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Monofocal | Spectacle Independence | 65 Percentage of Participants |
| Phakic | Spectacle Independence | 56 Percentage of Participants |