Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration

April 20, 2016 updated by: Alcon Research

Functional Benefit With ACRYSOF® Natural Chromophore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects completed 2 visits to the investigational site.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years to 73 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Visit 2, Up to Day 30
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.
Visit 2, Up to Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Sr Clinical Manager, GCRA-Global Med Affairs, Operations, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Estimate)

May 26, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILQ830-P001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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