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Completed

NCT Number: NCT02219997

Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration

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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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Subjects completed 2 visits to the investigational site.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clear clip-on glasses

Device

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

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

Primary outcomes

  1. Change in Braking Reaction Time From No-glare to Glare

    Time frame: 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 outcomes

  1. Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)

    Time frame: 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.

  2. Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Functional Benefit With ACRYSOF® Natural Chromophore

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 19, 2014
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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