An interventional study of Acrylic IOL and Silicone IOL in Pseudophakia, sponsored by Alcon, a Novartis Company. Completed. Per ClinicalTrials.gov, last updated 2016-12-09.
Sponsored by Alcon, a Novartis Company · Not applicable and Interventional
The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take place in Japan.
Exclusion Criteria:
Acrylic IOL, prior implantation (1994-2000) in one or both eyes
Device: Acrylic IOL
Silicone IOL, prior implantation (1994-2000) in one or both eyes
Device: Silicone IOL
PMMA IOL, prior implantation (1994-2000) in one or both eyes
Device: PMMA IOL
Acrylic IOL for long-term implantation in the cataract patient
Also known as: AcrySof® Model MA30BA, AcrySof® Model MA60BM
Silicone IOL for long-term implantation in the cataract patient
Polymethylmethacrylate IOL for long-term implantation in the cataract patient
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit
Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.
Time frame: Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)
Subjects were recruited from 11 study centers located in Japan.
| Milestone | AcrySof | Silicone | PMMA |
|---|---|---|---|
| Started | 31 | 37 | 30 |
| Completed | 31 | 37 | 30 |
| Not completed | 0 | 0 | 0 |
Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.
| logMAR | AcrySof | Silicone | PMMA |
|---|---|---|---|
| Baseline | -0.06 ± 0.07 | -0.09 ± 0.07 | -0.07 ± 0.08 |
| Change from baseline | 0.01 ± 0.08 | 0.04 ± 0.06 | -0.01 ± 0.05 |
Collected over Adverse events (AEs) were collected for the duration of a subject's participation in the study; retrospectively 14 to 20 years and prospectively for a single visit. This analysis group includes all subjects who used the study devices and underwent the long-term post-implantation visit examination. Ocular adverse events are presented for both study eye and non-study eye combined.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AcrySof (Retrospective) | — | 0/31 (0%) | 0/31 (0%) |
| Silicone (Retrospective) | — | 0/37 (0%) | 3/37 (8.1%) |
| PMMA (Retrospective) | — | 0/30 (0%) | 4/30 (13.3%) |
| AcrySof (Prospective) | — | 0/31 (0%) | 0/31 (0%) |
| Silicone (Prospective) | — | 0/37 (0%) | 0/37 (0%) |
| PMMA (Prospective) | — | 0/30 (0%) | 0/30 (0%) |
| Event | AcrySof (Retrospective) | Silicone (Retrospective) | PMMA (Retrospective) | AcrySof (Prospective) | Silicone (Prospective) | PMMA (Prospective) |
|---|---|---|---|---|---|---|
| posterior capsule opacificationEye disorders | 0/31 | 3/37 | 4/30 | 0/31 | 0/37 | 0/30 |
This analysis population includes all subjects who used the study devices and underwent the long-term post-implantation visit examination (Safety Set).
| Age, Customized(subjects) | AcrySof | Silicone | PMMA | Total |
|---|---|---|---|---|
| <70 years | 2 | 4 | 6 | 12 |
| ≥70 and ≤79 years | 13 | 21 | 11 | 45 |
| ≥80 and ≤89 years | 12 | 12 | 9 | 33 |
| >90 years | 4 | 0 | 4 | 8 |
| Sex: Female, Male(Participants) | AcrySof | Silicone | PMMA | Total |
|---|---|---|---|---|
| Female | 23 | 24 | 19 | 66 |
| Male | 8 | 13 | 11 | 32 |
No study locations are listed for this record.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Alcon, a Novartis Company