NCT02219997 - Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

SINGLE

Enrollment

90

Conditions

Cataract

Interventions

Clear clip-on glassesDEVICE

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

Blue light filter clip-on glassesDEVICE

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

ACRYSOF® IQ IOLDEVICE

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

Eligibility

Sex: ALLMin age: 65 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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