Trial Outcomes & Findings for Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL) (NCT NCT00747227)
NCT ID: NCT00747227
Last Updated: 2011-11-11
Results Overview
Snellen Equivalent visual acuity of 20/40 or better
COMPLETED
PHASE3
250 participants
One year
2011-11-11
Participant Flow
250 subjects from normal cataract populations who were undergoing primary phacoemulsification with lens implantation and did not have any other visually significant ocular pathologies were selected at 12 investigation sites across the country
Participant milestones
| Measure |
ZV9003 Intraocular Lens
modified light transmission intraocular lens
|
ZA9003 Intraocular Lens
monofocal acrylic intraocular lens
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
124
|
|
Overall Study
COMPLETED
|
120
|
120
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
ZV9003 Intraocular Lens
modified light transmission intraocular lens
|
ZA9003 Intraocular Lens
monofocal acrylic intraocular lens
|
|---|---|---|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Illness
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)
Baseline characteristics by cohort
| Measure |
ZV9003 Intraocular Lens
n=126 Participants
modified light transmission intraocular lens
|
ZA9003 Intraocular Lens
n=124 Participants
monofocal acrylic intraocular lens
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
73.3 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
71.5 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
72.4 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Age, Customized
<60 years
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Age, Customized
Between 60 and 69 years
|
35 participants
n=5 Participants
|
41 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Age, Customized
Between 70 and 79 years
|
57 participants
n=5 Participants
|
54 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Age, Customized
>=80
|
30 participants
n=5 Participants
|
21 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=5 Participants
|
124 participants
n=7 Participants
|
250 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.
Snellen Equivalent visual acuity of 20/40 or better
Outcome measures
| Measure |
ZV9003 Intraocular Lens
n=119 Participants
modified light transmission intraocular lens
|
ZA9003 Intraocular Lens
n=120 Participants
monofocal acrylic intraocular lens
|
|---|---|---|
|
Best Corrected Distance Visual Acuity
|
119 participants
|
120 participants
|
PRIMARY outcome
Timeframe: One YearPopulation: One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.
Snellen Equivalent of 20/40 or better at one year
Outcome measures
| Measure |
ZV9003 Intraocular Lens
n=119 Participants
modified light transmission intraocular lens
|
ZA9003 Intraocular Lens
n=120 Participants
monofocal acrylic intraocular lens
|
|---|---|---|
|
Uncorrected Distance Visual Acuity
|
110 participants
|
116 participants
|
SECONDARY outcome
Timeframe: 4-6 monthsPopulation: Binocular contrast sensitivity testing was reported for all binocular subjects with data available at the 4-6 month visit on 120 subjects in each group. One ZA9003 subject was tested at 3.0 cpd and not tested for 6.0 cpd through 18.0 cpd (mesopic and photopic). Testing for levels 6.0 through 18.0 were not reported.
Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.
Outcome measures
| Measure |
ZV9003 Intraocular Lens
n=120 Participants
modified light transmission intraocular lens
|
ZA9003 Intraocular Lens
n=120 Participants
monofocal acrylic intraocular lens
|
|---|---|---|
|
Contrast Sensitivity
Mesopic condition at 3.0 cpd
|
1.62 log contrast
Interval 1.58 to 1.66
|
1.62 log contrast
Interval 1.58 to 1.66
|
|
Contrast Sensitivity
Mesopic condition at 6.0 cpd
|
1.65 log contrast
Interval 1.61 to 1.69
|
1.63 log contrast
Interval 1.58 to 1.68
|
|
Contrast Sensitivity
Mesopic condition at 12.0 cpd
|
1.14 log contrast
Interval 1.07 to 1.21
|
1.17 log contrast
Interval 1.1 to 1.24
|
|
Contrast Sensitivity
Mesopic condition at 18.0 cpd
|
0.60 log contrast
Interval 0.54 to 0.66
|
0.65 log contrast
Interval 0.59 to 0.71
|
|
Contrast Sensitivity
Photopic condition at 3.0 cpd
|
1.76 log contrast
Interval 1.73 to 1.79
|
1.74 log contrast
Interval 1.71 to 1.78
|
|
Contrast Sensitivity
Photopic condition at 6.0 cpd
|
1.91 log contrast
Interval 1.88 to 1.94
|
1.94 log contrast
Interval 1.91 to 1.98
|
|
Contrast Sensitivity
Photopic condition at 12.0 cpd
|
1.58 log contrast
Interval 1.54 to 1.62
|
1.59 log contrast
Interval 1.55 to 1.64
|
|
Contrast Sensitivity
Photopic condition at 18.0 cpd
|
1.09 log contrast
Interval 1.04 to 1.14
|
1.14 log contrast
Interval 1.09 to 1.19
|
SECONDARY outcome
Timeframe: One YearPopulation: Two subjects in the ZV9003 group did not complete the one year questionnaire.
Subjects indicating a subjective response to a multiple choice question, "At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?", on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit.
Outcome measures
| Measure |
ZV9003 Intraocular Lens
n=118 Participants
modified light transmission intraocular lens
|
ZA9003 Intraocular Lens
n=119 Participants
monofocal acrylic intraocular lens
|
|---|---|---|
|
Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".
|
112 participants
|
113 participants
|
Adverse Events
ZV9003 Intraocular Lens
ZA9003 Intraocular Lens
Serious adverse events
| Measure |
ZV9003 Intraocular Lens
n=126 participants at risk
modified light transmission intraocular lens
|
ZA9003 Intraocular Lens
n=124 participants at risk
monofocal acrylic intraocular lens
|
|---|---|---|
|
Eye disorders
Retinal Tear requiring secondary surgical intervention
|
0.79%
1/126 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Nicholas Taranatino, O.D., Head, Global Clinical Research & Devlopment
Abbott medical Optics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee PIs may not publish or disclose study data without Sponsor's prior written approval.
- Publication restrictions are in place
Restriction type: OTHER