Trial Outcomes & Findings for Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens (NCT NCT00760487)
NCT ID: NCT00760487
Last Updated: 2012-01-16
Results Overview
Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
COMPLETED
PHASE4
120 participants
Pre-operative, 1 month, 3 month, and 6 month post-operative
2012-01-16
Participant Flow
Subjects \>21 years of age, either sex and any race. Diagnosis of cataracts in one or both eyes.
Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
Participant milestones
| Measure |
AcrySof Toric IOL
Implantation of the AcrySof Toric Intraocular lens (IOL)
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
117
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
AcrySof Toric IOL
Implantation of the AcrySof Toric Intraocular lens (IOL)
|
|---|---|
|
Overall Study
Unilateral implantation
|
3
|
Baseline Characteristics
Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens
Baseline characteristics by cohort
| Measure |
AcrySof Toric IOL
n=120 Participants
Implantation of the AcrySof Toric Intraocular lens (IOL)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre-operative, 1 month, 3 month, and 6 month post-operativePre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Outcome measures
| Measure |
AcrySof Toric IOL
n=117 Participants
Implantation of the AcrySof Toric Intraocular lens (IOL)
|
|---|---|
|
Visual Acuity (VA)
1 Day Post-operative
|
0.06 logMAR
Standard Deviation 0.12
|
|
Visual Acuity (VA)
Pre-Operative
|
0.7 logMAR
Standard Deviation 0.06
|
|
Visual Acuity (VA)
3 Months Post-operative
|
0.05 logMAR
Standard Deviation 0.11
|
|
Visual Acuity (VA)
6 Months Post-operative
|
0.05 logMAR
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: 6 months post-operativePercentage of subjects reporting that they never wear glasses at the 6 month post-operative visit
Outcome measures
| Measure |
AcrySof Toric IOL
n=117 Participants
Implantation of the AcrySof Toric Intraocular lens (IOL)
|
|---|---|
|
Spectacle Independence
|
69 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 months post-operativeEvaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.
Outcome measures
| Measure |
AcrySof Toric IOL
n=117 Participants
Implantation of the AcrySof Toric Intraocular lens (IOL)
|
|---|---|
|
IOL Rotation
Less than or equal to 5 degrees
|
91 Percentage of Participants
|
|
IOL Rotation
Less than or equal to 10 degrees
|
99 Percentage of Participants
|
Adverse Events
AcrySof Toric IOL
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AcrySof Toric IOL
n=120 participants at risk
Implantation of the AcrySof Toric Intraocular lens (IOL)
|
|---|---|
|
Surgical and medical procedures
Lens Repositioning
|
0.83%
1/120 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No paper that incorporates Sponsor Condfidential information will be submitted for publication without Sponsor's prior written agreement.
- Publication restrictions are in place
Restriction type: OTHER