Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration

Study Overview
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Brief Summary
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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.

Detailed Description
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Subjects completed 2 visits to the investigational site.

Official Title
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Functional Benefit With ACRYSOF® Natural Chromophore

Conditions
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Cataract

Intervention / Treatment
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* Device: Clear clip-on glasses
* Device: Blue light filter clip-on glasses
* Device: ACRYSOF® IQ IOL
* Device: Clear IOL


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACRYSOF IQ IOL<br>ACRYSOF® IQ IOL with or without clear clip-on glasses worn for 3 hours | Device: Clear clip-on glasses<br>* Clip-on glasses with no blue light filtering properties used as a placebo<br>Device: ACRYSOF® IQ IOL<br>* AcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted<br>|
| Active Comparator: Clear IOL<br>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 | Device: Clear clip-on glasses<br>* Clip-on glasses with no blue light filtering properties used as a placebo<br>Device: Blue light filter clip-on glasses<br>* Clip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs<br>Device: Clear IOL<br>* Clear IOL, previously implanted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Intraocular lens (IOL), AcrySof