Trial Outcomes & Findings for Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO). (NCT NCT00758745)
NCT ID: NCT00758745
Last Updated: 2014-08-19
Results Overview
Development of PCO using the EPCO Score. The EPCO score incorporates planimetric \& grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.
COMPLETED
NA
81 participants
Up to 3 years
2014-08-19
Participant Flow
Participant milestones
| Measure |
Model SN60WF
Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
|
Model MA60AC
Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
21
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
Baseline characteristics by cohort
| Measure |
Model SN60WF
n=81 Participants
Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
|
Model MA60AC
n=81 Participants
Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
116 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsDevelopment of PCO using the EPCO Score. The EPCO score incorporates planimetric \& grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.
Outcome measures
| Measure |
Model SN60WF
n=60 Participants
Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
|
Model MA60AC
n=60 Participants
Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
|
|---|---|---|
|
Posterior Capsule Opacification (PCO)
|
0.18 Units on a scale
Standard Deviation 0.41
|
0.15 Units on a scale
Standard Deviation 0.44
|
Adverse Events
Model SN60WF
Model MA60AC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Research
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee All study data is held confidential and not be disclosed to a 3rd party without written consent from Alcon Laboratories for a period of 3 years.
- Publication restrictions are in place
Restriction type: OTHER