A Phase 4 interventional study of ReSTOR +3 and Crystalens HD in Cataract, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2011-08-09.
Sponsored by Alcon Research · Phase 4, Interventional, and Treatment
The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 132 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
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Exclusion Criteria:
Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
Device: ReSTOR +3
Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
Device: Crystalens HD
Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
Device: Crystalens AO
Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.
Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.
Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.
Best Corrected Visual Acuity
Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) 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 visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.
Time frame: 6 Months after surgery
Bilateral diagnosis of cataracts of subjects \>21 years of age.
| Milestone | ReSTOR +3 | Crystalens HD | Crystalens AO |
|---|---|---|---|
| Started | 47 | 44 | 41 |
| Completed | 44 | 41 | 41 |
| Not completed | 3 | 3 | 0 |
Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) 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 visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.
| logMAR | ReSTOR +3 | Crystalens HD | Crystalens AO |
|---|---|---|---|
| 4m (far) Distance | -0.075 ± 0.100 | -0.080 ± 0.103 | -0.081 ± 0.110 |
| 60cm (intermediate) Distance | 0.227 ± 0.119 | 0.176 ± 0.139 | 0.200 ± 0.154 |
| 40 cm (near) Distance | 0.057 ± 0.086 | 0.364 ± 0.183 | 0.420 ± 0.188 |
| Preferred Distance | 0.055 ± 0.121 | 0.223 ± 0.146 | 0.222 ± 0.138 |
Collected over Day of surgery until visit 6 months following surgery.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ReSTOR +3 | — | 0/47 (0%) | 0/47 (0%) |
| Crystalens HD | — | 0/44 (0%) | 0/44 (0%) |
| Crystalens AO | — | 0/41 (0%) | 0/41 (0%) |
| Age Continuous(years) | ReSTOR +3 | Crystalens HD | Crystalens AO | Total |
|---|---|---|---|---|
| Mean | 63.4 ± 9.4 | 64 ± 7.8 | 65.3 ± 7.5 | 64.23 ± 8.23 |
| Sex: Female, Male(Participants) | ReSTOR +3 | Crystalens HD | Crystalens AO | Total |
|---|---|---|---|---|
| Female | 28 | 25 | 26 | 79 |
| Male | 19 | 19 | 15 | 53 |
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Alcon Research