Trial Outcomes & Findings for Contralateral ReSTOR / Monofocal or Phakic Eye (NCT NCT00731640)
NCT ID: NCT00731640
Last Updated: 2010-03-23
Results Overview
Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
COMPLETED
PHASE4
52 participants
6 months
2010-03-23
Participant Flow
This is a retrospective study that required patients with unilateral implantation of the AcrySof ReSTOR Intraocular Lens (IOL). Patients were to be free of conditions or ocular co-morbidities that may affect visual acuity.
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. This study was not randomized.
Participant milestones
| Measure |
Monofocal
Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
|
Phakic
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
32
|
|
Overall Study
COMPLETED
|
20
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contralateral ReSTOR / Monofocal or Phakic Eye
Baseline characteristics by cohort
| Measure |
Monofocal
n=20 Participants
Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
|
Phakic
n=32 Participants
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 monthsUncorrected Visual Acuity (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 |
Monofocal
n=20 Participants
Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
|
Phakic
n=32 Participants
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
|
|---|---|---|
|
Visual Acuity
Distance
|
-0.04 LogMar
Standard Deviation 0.09
|
-0.01 LogMar
Standard Deviation 0.09
|
|
Visual Acuity
Intermediate
|
0.14 LogMar
Standard Deviation 0.13
|
0.18 LogMar
Standard Deviation 0.15
|
|
Visual Acuity
Near (Preferred Distance)
|
0.04 LogMar
Standard Deviation 0.10
|
0.09 LogMar
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: 6 MonthsContrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
Outcome measures
| Measure |
Monofocal
n=20 Participants
Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
|
Phakic
n=32 Participants
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
|
|---|---|---|
|
Contrast Sensitivity
Photopic CS, 3 cycles per degree (cpd)
|
1.95 Log Units
Standard Deviation 0.13
|
1.90 Log Units
Standard Deviation 0.13
|
|
Contrast Sensitivity
Mesopic CS, 3 cpd
|
1.85 Log Units
Standard Deviation 0.18
|
1.84 Log Units
Standard Deviation 0.19
|
|
Contrast Sensitivity
Mesopic w/Glare CS, 3 cpd
|
1.82 Log Units
Standard Deviation 0.18
|
1.81 Log Units
Standard Deviation 0.22
|
|
Contrast Sensitivity
Photopic CS, 6 cpd
|
2.10 Log Units
Standard Deviation 0.24
|
2.05 Log Units
Standard Deviation 0.20
|
|
Contrast Sensitivity
Mesopic CS, 6 cpd
|
1.76 Log Units
Standard Deviation 0.36
|
1.62 Log Units
Standard Deviation 0.39
|
|
Contrast Sensitivity
Mesopic w/Glare CS, 6 cpd
|
1.73 Log Units
Standard Deviation 0.23
|
1.57 Log Units
Standard Deviation 0.56
|
|
Contrast Sensitivity
Photopic CS, 12 cpd
|
1.78 Log Units
Standard Deviation 0.26
|
1.66 Log Units
Standard Deviation 0.27
|
|
Contrast Sensitivity
Mesopic CS, 12 cpd
|
1.18 Log Units
Standard Deviation 0.51
|
0.95 Log Units
Standard Deviation 0.51
|
|
Contrast Sensitivity
Mesopic w/Glare CS, 12 cpd
|
1.21 Log Units
Standard Deviation 0.38
|
0.88 Log Units
Standard Deviation 0.54
|
|
Contrast Sensitivity
Photopic CS, 18 cpd
|
1.18 Log Units
Standard Deviation 0.39
|
1.14 Log Units
Standard Deviation 0.31
|
|
Contrast Sensitivity
Mesopic CS, 18 cpd
|
0.61 Log Units
Standard Deviation 0.52
|
0.49 Log Units
Standard Deviation 0.58
|
|
Contrast Sensitivity
Mesopic w/Glare CS, 18 cpd
|
0.57 Log Units
Standard Deviation 0.41
|
0.40 Log Units
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: 6 Months PostoperativeAverage rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).
Outcome measures
| Measure |
Monofocal
n=20 Participants
Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
|
Phakic
n=32 Participants
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
|
|---|---|---|
|
Patient Satisfaction
|
6.85 Units on a Scale
Standard Deviation 2.41
|
7.63 Units on a Scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: 6 MonthsThe percentage of patients reporting spectacle independence (no longer needing to wear glasses).
Outcome measures
| Measure |
Monofocal
n=20 Participants
Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
|
Phakic
n=32 Participants
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
|
|---|---|---|
|
Spectacle Independence
|
65 Percentage of Participants
|
56 Percentage of Participants
|
Adverse Events
Monofocal
Phakic
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 Specify: No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.
- Publication restrictions are in place
Restriction type: OTHER