Trial Outcomes & Findings for A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs) (NCT NCT01166971)
NCT ID: NCT01166971
Last Updated: 2011-11-24
Results Overview
A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".
COMPLETED
PHASE4
65 participants
3 months after surgery
2011-11-24
Participant Flow
Bilateral diagnosis of cataracts of subjects \>21 years of age
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
Participant milestones
| Measure |
ReSTOR +3
Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
|
Tecnis MF
Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
31
|
|
Overall Study
COMPLETED
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)
Baseline characteristics by cohort
| Measure |
ReSTOR +3
n=33 Participants
Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
|
Tecnis MF
n=31 Participants
Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
|
Total
n=64 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
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months after surgeryPopulation: In the ReSTOR +3 population, 1 subject did not complete the assessment at -5.00 D; therefore, only 32 subjects were used for this measure.
A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".
Outcome measures
| Measure |
ReSTOR +3
n=33 Participants
Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
|
Tecnis MF
n=29 Participants
Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
|
|---|---|---|
|
Defocus Curve
-5.00 Diopter (D)
|
0.585 LogMAR
Standard Deviation 0.204
|
0.653 LogMAR
Standard Deviation 0.116
|
|
Defocus Curve
-4.50 D
|
0.490 LogMAR
Standard Deviation 0.204
|
0.475 LogMAR
Standard Deviation 0.115
|
|
Defocus Curve
-4.00 D
|
0.388 LogMAR
Standard Deviation 0.189
|
0.337 LogMAR
Standard Deviation 0.107
|
|
Defocus Curve
-3.50 D
|
0.261 LogMAR
Standard Deviation 0.183
|
0.168 LogMAR
Standard Deviation 0.114
|
|
Defocus Curve
-3.00 D
|
0.126 LogMAR
Standard Deviation 0.185
|
0.046 LogMAR
Standard Deviation 0.104
|
|
Defocus Curve
-2.50 D
|
0.017 LogMAR
Standard Deviation 0.144
|
0.073 LogMAR
Standard Deviation 0.113
|
|
Defocus Curve
-2.00 D
|
0.055 LogMAR
Standard Deviation 0.147
|
0.222 LogMAR
Standard Deviation 0.178
|
|
Defocus Curve
-1.50 D
|
0.245 LogMAR
Standard Deviation 0.175
|
0.326 LogMAR
Standard Deviation 0.120
|
|
Defocus Curve
-1.00 D
|
0.212 LogMAR
Standard Deviation 0.144
|
0.225 LogMAR
Standard Deviation 0.128
|
|
Defocus Curve
-0.50 D
|
0.052 LogMAR
Standard Deviation 0.132
|
0.072 LogMAR
Standard Deviation 0.120
|
|
Defocus Curve
0.00 D
|
-0.048 LogMAR
Standard Deviation 0.097
|
-0.044 LogMAR
Standard Deviation 0.085
|
|
Defocus Curve
0.50 D
|
0.035 LogMAR
Standard Deviation 0.112
|
0.032 LogMAR
Standard Deviation 0.111
|
|
Defocus Curve
1.00 D
|
0.258 LogMAR
Standard Deviation 0.140
|
0.237 LogMAR
Standard Deviation 0.200
|
|
Defocus Curve
1.50 D
|
0.434 LogMAR
Standard Deviation 0.153
|
0.364 LogMAR
Standard Deviation 0.176
|
|
Defocus Curve
2.00 D
|
0.539 LogMAR
Standard Deviation 0.168
|
0.446 LogMAR
Standard Deviation 0.136
|
Adverse Events
ReSTOR +3
Tecnis MF
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Alcon Clinical
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee The existence of this clinical study is confidential and should not be discussed with persons outside of the study. You shall hold confidential, and not disclose directly or indirectly to any third party other than those persons involved in the study who have a need to know, the protocol, the data arising out of the study, and any other information related to the study or to Alcon's products or research programs that is provided by Alcon to you (the "Confidential Information").
- Publication restrictions are in place
Restriction type: OTHER