Cataract
Conditions
Keywords
cataract
Brief summary
To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.
Interventions
DEVICESN60AT
Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal.
DEVICESN60WF
Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with bilateral senile cataracts * Age \> 50 years * Fit for hospital follow ups * Pupils dilating \> 6mm preoperatively * Eyes expected to see 6/12 or better postoperatively
Exclusion criteria
* Diabetes * On treatment for glaucoma * Other ocular pathology * Previous ocular surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posterior Capsule Opacification (PCO) | 2 years after surgery | 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. |
| 100% LogMAR Best Corrected Visual Acuity (BCVA) | 24 months after surgery | 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. |
| 9% LogMAR Best Corrected Visual Acuity (BCVA) | 24 months after surgery | 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. |
Countries
United States
Participant flow
Recruitment details
Uncomplicated age-related bilateral cataract with the potential to see 20/40 or better in each eye
Pre-assignment details
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| SN60AT Implantation with the AcrySof Intraocular Lens Model SN60AT | 52 |
| SN60WF Implantation with the AcrySof Intraocular Lens Model SN60WF | 52 |
| Total | 104 |
Baseline characteristics
| Characteristic | SN60AT | SN60WF | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 40 Participants | 40 Participants | 80 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Male | 23 Participants | 23 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
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
Population: Data for all patients completing the 24 month visit were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SN60AT | 100% LogMAR Best Corrected Visual Acuity (BCVA) | 0.04 LogMAR | Standard Deviation 0.1 |
| SN60WF | 100% LogMAR Best Corrected Visual Acuity (BCVA) | 0.07 LogMAR | Standard Deviation 0.2 |
Primary
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
Population: Data for all patients completing the 24 month visit were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SN60AT | 9% LogMAR Best Corrected Visual Acuity (BCVA) | 0.42 LogMAR | Standard Deviation 0.2 |
| SN60WF | 9% LogMAR Best Corrected Visual Acuity (BCVA) | 0.45 LogMAR | Standard Deviation 0.2 |
Primary
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
Population: Data for all patients completing the 24 month visit were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SN60AT | Posterior Capsule Opacification (PCO) | 11.58 Percentage of PCO | Standard Deviation 20.18 |
| SN60WF | Posterior Capsule Opacification (PCO) | 14.04 Percentage of PCO | Standard Deviation 22.15 |