A Phase 4 interventional study of ReSTOR in Cataracts, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-03-23.
Sponsored by Alcon Research · Phase 4, Interventional, and Treatment
Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 52 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye
Device: ReSTOR
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
Device: ReSTOR
AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted
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
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
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
Spectacle Independence
The percentage of patients reporting spectacle independence (no longer needing to wear glasses).
Time frame: 6 Months
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.
| Milestone | Monofocal | Phakic |
|---|---|---|
| Started | 20 | 32 |
| Completed | 20 | 32 |
| Not completed | 0 | 0 |
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.
| LogMar | Monofocal | Phakic |
|---|---|---|
| Distance | -0.04 ± 0.09 | -0.01 ± 0.09 |
| Intermediate | 0.14 ± 0.13 | 0.18 ± 0.15 |
| Near (Preferred Distance) | 0.04 ± 0.10 | 0.09 ± 0.12 |
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.
| Log Units | Monofocal | Phakic |
|---|---|---|
| Photopic CS, 3 cycles per degree (cpd) | 1.95 ± 0.13 | 1.90 ± 0.13 |
| Mesopic CS, 3 cpd | 1.85 ± 0.18 | 1.84 ± 0.19 |
| Mesopic w/Glare CS, 3 cpd | 1.82 ± 0.18 | 1.81 ± 0.22 |
| Photopic CS, 6 cpd | 2.10 ± 0.24 | 2.05 ± 0.20 |
| Mesopic CS, 6 cpd | 1.76 ± 0.36 | 1.62 ± 0.39 |
| Mesopic w/Glare CS, 6 cpd | 1.73 ± 0.23 | 1.57 ± 0.56 |
| Photopic CS, 12 cpd | 1.78 ± 0.26 | 1.66 ± 0.27 |
| Mesopic CS, 12 cpd | 1.18 ± 0.51 | 0.95 ± 0.51 |
| Mesopic w/Glare CS, 12 cpd | 1.21 ± 0.38 | 0.88 ± 0.54 |
| Photopic CS, 18 cpd | 1.18 ± 0.39 | 1.14 ± 0.31 |
| Mesopic CS, 18 cpd | 0.61 ± 0.52 | 0.49 ± 0.58 |
| Mesopic w/Glare CS, 18 cpd | 0.57 ± 0.41 | 0.40 ± 0.52 |
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).
| Units on a Scale | Monofocal | Phakic |
|---|---|---|
| Patient Satisfaction | 6.85 ± 2.41 | 7.63 ± 2.24 |
The percentage of patients reporting spectacle independence (no longer needing to wear glasses).
| Percentage of Participants | Monofocal | Phakic |
|---|---|---|
| Spectacle Independence | 65 | 56 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Monofocal | — | 0/20 (0%) | 0/20 (0%) |
| Phakic | — | 0/32 (0%) | 0/32 (0%) |
| Age, Categorical(Participants) | Monofocal | Phakic | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 23 | 31 |
| >=65 years | 12 | 9 | 21 |
| Sex: Female, Male(Participants) | Monofocal | Phakic | Total |
|---|---|---|---|
| Female | 9 | 13 | 22 |
| Male | 11 | 19 | 30 |
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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