Trial Outcomes & Findings for Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration (NCT NCT02219997)
NCT ID: NCT02219997
Last Updated: 2016-05-26
Results Overview
Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.
COMPLETED
NA
90 participants
Visit 2, up to Day 30
2016-05-26
Participant Flow
Subjects were recruited from 6 study centers located in the US.
Of the 90 enrolled, 22 subjects were exited prior to reaction testing. This reporting group includes all subjects who were reaction tested (68).
Participant milestones
| Measure |
AcrySof IQ IOL
ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
|
Clear IOL: BLF First, Then Placebo Filter
Clear IOL with blue light filter clip-on glasses worn first and clear clip-on glasses worn second for 4 hours total
|
Clear IOL: Placebo Filter First, Then BLF
Clear IOL with clear clip-on glasses worn first and blue light filter clip-on glasses worn second for 4 hours total
|
|---|---|---|---|
|
First Filter
STARTED
|
33
|
17
|
18
|
|
First Filter
COMPLETED
|
33
|
17
|
18
|
|
First Filter
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Filter
STARTED
|
0
|
17
|
18
|
|
Second Filter
COMPLETED
|
0
|
17
|
18
|
|
Second Filter
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration
Baseline characteristics by cohort
| Measure |
AcrySof IQ IOL
n=33 Participants
ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
|
Clear IOL
n=35 Participants
Clear IOL with blue light filter clip-on glasses and clear clip-on glasses, worn in a cross-over fashion, as randomized, for 4 hours total
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
70.3 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
70.6 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 2, up to Day 30Population: This analysis population includes subjects who were reaction tested with no major protocol violations (per protocol).
Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.
Outcome measures
| Measure |
AcrySof IQ IOL
n=33 Participants
ACRYSOF® IQ IOL without filters
|
Clear IOL
n=33 Participants
Clear IOL without filters
|
|---|---|---|
|
Change in Braking Reaction Time From No-glare to Glare
|
0.07 seconds
Standard Deviation 0.12
|
0.15 seconds
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Visit 2, Up to Day 30Population: This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.
Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. This outcome measure was pre-specified for Clear IOL only.
Outcome measures
| Measure |
AcrySof IQ IOL
n=32 Participants
ACRYSOF® IQ IOL without filters
|
Clear IOL
n=32 Participants
Clear IOL without filters
|
|---|---|---|
|
Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)
|
0.17 seconds
Standard Deviation 0.16
|
0.16 seconds
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Visit 2, Up to Day 30Population: This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.
Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.
Outcome measures
| Measure |
AcrySof IQ IOL
n=32 Participants
ACRYSOF® IQ IOL without filters
|
Clear IOL
n=32 Participants
Clear IOL without filters
|
|---|---|---|
|
Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)
|
0.12 seconds
Standard Deviation 0.12
|
0.16 seconds
Standard Deviation 0.20
|
Adverse Events
Pre-treatment
AcrySof IQ IOL
Clear IOL
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Global Brand Med Affairs Lead, VGR
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER