An interventional study of SN60AT and SN60WF in Cataract, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2010-12-22.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 104 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
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Exclusion Criteria:
Implantation with the AcrySof Intraocular Lens Model SN60AT
Device: SN60AT
Implantation with the AcrySof Intraocular Lens Model SN60WF
Device: SN60WF
Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal.
Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal.
Posterior Capsule Opacification (PCO)
Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.
Time frame: 2 years after surgery
100% LogMAR Best Corrected Visual Acuity (BCVA)
Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background. 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: 24 months after surgery
9% LogMAR Best Corrected Visual Acuity (BCVA)
Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background. 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: 24 months after surgery
Uncomplicated age-related bilateral cataract with the potential to see 20/40 or better in each eye
| Milestone | SN60AT | SN60WF |
|---|---|---|
| Started | 52 | 52 |
| Completed | 44 | 44 |
| Not completed | 8 | 8 |
Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.
| Percentage of PCO | SN60AT | SN60WF |
|---|---|---|
| Posterior Capsule Opacification (PCO) | 11.58 ± 20.18 | 14.04 ± 22.15 |
Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
| LogMAR | SN60AT | SN60WF |
|---|---|---|
| 100% LogMAR Best Corrected Visual Acuity (BCVA) | 0.04 ± 0.1 | 0.07 ± 0.2 |
Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
| LogMAR | SN60AT | SN60WF |
|---|---|---|
| 9% LogMAR Best Corrected Visual Acuity (BCVA) | 0.42 ± 0.2 | 0.45 ± 0.2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SN60AT | — | 0/52 (0%) | 0/52 (0%) |
| SN60WF | — | 0/52 (0%) | 0/52 (0%) |
| Age, Categorical(Participants) | SN60AT | SN60WF | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 12 | 24 |
| >=65 years | 40 | 40 | 80 |
| Sex: Female, Male(Participants) | SN60AT | SN60WF | Total |
|---|---|---|---|
| Female | 29 | 29 | 58 |
| Male | 23 | 23 | 46 |
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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