Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Clear clip-on glasses; Device: ACRYSOF® IQ IOL; Device: Blue light filter clip-on glasses; Device: Clear IOL

• Registration Number: NCT02219997
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Subjects completed 2 visits to the investigational site.

Study Timeline

• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-19
• Study Start: 2014-10
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2016-02-24
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Results First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACRYSOF IQ IOL	ACRYSOF® IQ IOL	ACRYSOF® IQ IOL with or without clear clip-on glasses worn for 3 hours
Clear IOL	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
Clear IOL	Clear clip-on glasses	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
ACRYSOF IQ IOL	Clear clip-on glasses	ACRYSOF® IQ IOL with or without clear clip-on glasses worn for 3 hours
Clear IOL	Blue light filter clip-on glasses	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

Primary Outcome Measures

Name	Time	Method
Change in Braking Reaction Time From No-glare to Glare	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 Outcome Measures

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