Cataract
Conditions
Keywords
Cataract, Intraocular lens (IOL), AcrySof
Brief summary
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.
Detailed description
Subjects completed 2 visits to the investigational site.
Interventions
DEVICEClear clip-on glasses
Clip-on glasses with no blue light filtering properties used as a placebo
Clip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs
DEVICEACRYSOF® IQ IOL
AcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted
DEVICEClear IOL
Clear IOL, previously implanted
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Pseudophakes with ACRYSOF® IQ monofocal IOLs or clear (no blue light filter) IOLs in both eyes for at least 3 months. * Willing and able to understand and sign an informed consent form. * Corrected visual acuity (CVA) of 20/40 or better. * Have a valid driver's license. * Depth perception of at least 100 arc seconds. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Ocular pathology, degeneration, or media opacity. * Color vision defect. * Use of ocular or systemic medications that impact macular pigment density or reaction time, including but not limited to, lutein, zeaxanthin, barbiturates, tranquilizers or amphetamines. * System conditions affecting connective tissue or sensory-motor coordination. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Braking Reaction Time From No-glare to Glare | Visit 2, up to Day 30 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Braking Reaction Time From No-glare to Glare (Clear IOLs) | Visit 2, Up to Day 30 | 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. |
| Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF) | Visit 2, Up to Day 30 | 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. |
Participant flow
Recruitment details
Subjects were recruited from 6 study centers located in the US.
Pre-assignment details
Of the 90 enrolled, 22 subjects were exited prior to reaction testing. This reporting group includes all subjects who were reaction tested (68).
Participants by arm
| Arm | Count |
|---|---|
| AcrySof IQ IOL ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours | 33 |
| 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 | 35 |
| Total | 68 |
Baseline characteristics
| Characteristic | AcrySof IQ IOL | Clear IOL | Total |
|---|---|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 3.2 | 70.3 years STANDARD_DEVIATION 2.8 | 70.6 years STANDARD_DEVIATION 3 |
| Sex: Female, Male Female | 17 Participants | 21 Participants | 38 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 90 | 0 / 33 | 0 / 35 |
| serious Total, serious adverse events | 0 / 90 | 0 / 33 | 0 / 35 |
Outcome results
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.
Time frame: Visit 2, up to Day 30
Population: This analysis population includes subjects who were reaction tested with no major protocol violations (per protocol).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcrySof IQ IOL | Change in Braking Reaction Time From No-glare to Glare | 0.07 seconds | Standard Deviation 0.12 |
| Clear IOL | Change in Braking Reaction Time From No-glare to Glare | 0.15 seconds | Standard Deviation 0.21 |
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.
Time frame: Visit 2, Up to Day 30
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcrySof IQ IOL | 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 |
| Clear IOL | Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF) | 0.16 seconds | Standard Deviation 0.2 |
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.
Time frame: Visit 2, Up to Day 30
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcrySof IQ IOL | Change in Braking Reaction Time From No-glare to Glare (Clear IOLs) | 0.17 seconds | Standard Deviation 0.16 |
| Clear IOL | Change in Braking Reaction Time From No-glare to Glare (Clear IOLs) | 0.16 seconds | Standard Deviation 0.2 |