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Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration

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Status

Completed

Conditions

Cataract

Treatments

Device: Clear IOL
Device: Blue light filter clip-on glasses
Device: ACRYSOF® IQ IOL
Device: Clear clip-on glasses

Study type

Interventional

Funder types

Industry

Identifiers

NCT02219997
ILQ830-P001

Details and patient eligibility

About

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.

Full description

Subjects completed 2 visits to the investigational site.

Enrollment

90 patients

Sex

All

Ages

65 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

90 participants in 2 patient groups

ACRYSOF IQ IOL
Experimental group
Description:
ACRYSOF® IQ IOL with or without clear clip-on glasses worn for 3 hours
Treatment:
Device: Clear clip-on glasses
Device: ACRYSOF® IQ IOL
Clear IOL
Active Comparator group
Description:
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
Treatment:
Device: Clear clip-on glasses
Device: Blue light filter clip-on glasses
Device: Clear IOL

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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