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The purpose of this study is to compare the reaction time (as measured by braking reaction time in seconds during simulated driving) under glare and no-glare conditions in subjects implanted with ACRYSOF® IQ intraocular lenses (IOLs) to subjects implanted with clear IOLs. This study will enroll subjects previously implanted with IOLs in both eyes for at least 3 months.
Subjects completed 2 visits to the investigational site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACRYSOF IQ IOL | Experimental | ACRYSOF® IQ IOL with or without clear clip-on glasses worn for 3 hours |
|
| Clear IOL | Active Comparator | Clear IOL with or without blue light filter clip-on glasses and clear clip-on glasses, worn in a cross-over fashion, as randomized, for 4 hours total |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clear clip-on glasses | Device | Clip-on glasses with no blue light filtering properties used as a placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Braking Reaction Time From No-glare to Glare | 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. | Visit 2, up to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Braking Reaction Time From No-glare to Glare (Clear IOLs) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr Clinical Manager, GCRA-Global Med Affairs, Operations | Alcon Research | Study Director |
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Of the 90 enrolled, 22 subjects were exited prior to reaction testing. This reporting group includes all subjects who were reaction tested (68).
Subjects were recruited from 6 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | AcrySof IQ IOL | ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Filter |
| |||||||||||||
| Second Filter |
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This analysis population includes all subjects who were reaction tested.
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| ID | Title | Description |
|---|---|---|
| BG000 | AcrySof IQ IOL | ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours |
| BG001 | Clear IOL | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Braking Reaction Time From No-glare to Glare | 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 analysis population includes subjects who were reaction tested with no major protocol violations (per protocol). | Posted | Mean | Standard Deviation | seconds | Visit 2, up to Day 30 |
|
Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 30 days).
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs are reported as pre-treatment and treatment-emergent (initiation of experimental testing).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-treatment | All subjects from time to consent until initiation of experimental testing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Brand Med Affairs Lead, VGR | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Blue light filter clip-on glasses | Device | Clip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs |
|
| ACRYSOF® IQ IOL | Device | AcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted |
|
| Clear IOL | Device | Clear IOL, previously implanted |
|
| Visit 2, Up to Day 30 |
| Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF) | 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. | Visit 2, Up to Day 30 |
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Clear IOL | Clear IOL without filters |
|
|
| Secondary | Change in Braking Reaction Time From No-glare to Glare (Clear IOLs) | 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. | 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. | Posted | Mean | Standard Deviation | seconds | Visit 2, Up to Day 30 |
|
|
|
| Secondary | Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF) | 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 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. | Posted | Mean | Standard Deviation | seconds | Visit 2, Up to Day 30 |
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | AcrySof IQ IOL | All subjects implanted with ACRYSOF® IQ IOLs from time of initiation of experimental testing | 0 | 33 | 0 | 33 |
| EG002 | Clear IOL | All subjects implanted with Clear IOLs from time of initiation of experimental testing | 0 | 35 | 0 | 35 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.