Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

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.

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Detailed Description

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Subjects completed 2 visits to the investigational site.

Conditions

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Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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ACRYSOF IQ IOL

ACRYSOF® IQ IOL with or without clear clip-on glasses worn for 3 hours

Group Type EXPERIMENTAL

Clear clip-on glasses

Intervention Type DEVICE

Clip-on glasses with no blue light filtering properties used as a placebo

ACRYSOF® IQ IOL

Intervention Type DEVICE

AcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted

Clear IOL

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

Group Type ACTIVE_COMPARATOR

Clear clip-on glasses

Intervention Type DEVICE

Clip-on glasses with no blue light filtering properties used as a placebo

Blue light filter clip-on glasses

Intervention Type DEVICE

Clip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs

Clear IOL

Intervention Type DEVICE

Clear IOL, previously implanted

Interventions

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Clear clip-on glasses

Clip-on glasses with no blue light filtering properties used as a placebo

Intervention Type DEVICE

Blue light filter clip-on glasses

Clip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs

Intervention Type DEVICE

ACRYSOF® IQ IOL

AcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted

Intervention Type DEVICE

Clear IOL

Clear IOL, previously implanted

Intervention Type DEVICE

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.

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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No