Trial Outcomes & Findings for Posterior Capsule Opacification (PCO) Evaluation of the AcrySof SN60AT Lens vs. SN60WF Lens (NCT NCT00762021)
NCT ID: NCT00762021
Last Updated: 2010-12-22
Results Overview
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.
COMPLETED
NA
104 participants
2 years after surgery
2010-12-22
Participant Flow
Uncomplicated age-related bilateral cataract with the potential to see 20/40 or better in each eye
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
Participant milestones
| Measure |
SN60AT
Implantation with the AcrySof Intraocular Lens Model SN60AT
|
SN60WF
Implantation with the AcrySof Intraocular Lens Model SN60WF
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
|
Overall Study
COMPLETED
|
44
|
44
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Posterior Capsule Opacification (PCO) Evaluation of the AcrySof SN60AT Lens vs. SN60WF Lens
Baseline characteristics by cohort
| Measure |
SN60AT
n=52 Participants
Implantation with the AcrySof Intraocular Lens Model SN60AT
|
SN60WF
n=52 Participants
Implantation with the AcrySof Intraocular Lens Model SN60WF
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years after surgeryPopulation: Data for all patients completing the 24 month visit were analyzed.
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.
Outcome measures
| Measure |
SN60AT
n=40 Participants
Implantation with the AcrySof Intraocular Lens Model SN60AT
|
SN60WF
n=40 Participants
Implantation with the AcrySof Intraocular Lens Model SN60WF
|
|---|---|---|
|
Posterior Capsule Opacification (PCO)
|
11.58 Percentage of PCO
Standard Deviation 20.18 • Interval 9.53 to 31.75
|
14.04 Percentage of PCO
Standard Deviation 22.15 • Interval 11.79 to 36.19
|
PRIMARY outcome
Timeframe: 24 months after surgeryPopulation: Data for all patients completing the 24 month visit were analyzed.
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.
Outcome measures
| Measure |
SN60AT
n=40 Participants
Implantation with the AcrySof Intraocular Lens Model SN60AT
|
SN60WF
n=40 Participants
Implantation with the AcrySof Intraocular Lens Model SN60WF
|
|---|---|---|
|
100% LogMAR Best Corrected Visual Acuity (BCVA)
|
0.04 LogMAR
Standard Deviation 0.1 • Interval 0.0 to 0.08
|
0.07 LogMAR
Standard Deviation 0.2 • Interval -0.02 to 0.04
|
PRIMARY outcome
Timeframe: 24 months after surgeryPopulation: Data for all patients completing the 24 month visit were analyzed.
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.
Outcome measures
| Measure |
SN60AT
n=40 Participants
Implantation with the AcrySof Intraocular Lens Model SN60AT
|
SN60WF
n=40 Participants
Implantation with the AcrySof Intraocular Lens Model SN60WF
|
|---|---|---|
|
9% LogMAR Best Corrected Visual Acuity (BCVA)
|
0.42 LogMAR
Standard Deviation 0.2 • Interval 0.36 to 0.48
|
0.45 LogMAR
Standard Deviation 0.2 • Interval 0.29 to 0.37
|
Adverse Events
SN60AT
SN60WF
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications relating to the study should not be made without the Sponsor's prior written consent and not prior to the completion of the study. The sponsor shall be notified in writing at least 60 days prior to submission of any intention on the part of the Investigator to publish and shall provide the sponsor an opportunity to comment on any proposed publications.
- Publication restrictions are in place
Restriction type: OTHER