Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration
Functional Benefit With ACRYSOF® Natural Chromophore
1 other identifier
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2014
CompletedFirst Posted
Study publicly available on registry
August 19, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
May 26, 2016
CompletedMay 26, 2016
April 1, 2016
5 months
August 18, 2014
February 24, 2016
April 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Visit 2, up to Day 30
Secondary Outcomes (2)
Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)
Visit 2, Up to Day 30
Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)
Visit 2, Up to Day 30
Study Arms (2)
ACRYSOF IQ IOL
EXPERIMENTALACRYSOF® IQ IOL with or without clear clip-on glasses worn for 3 hours
Clear IOL
ACTIVE COMPARATORClear 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
Interventions
Clip-on glasses with no blue light filtering properties used as a placebo
Clip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs
AcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Brand Med Affairs Lead, VGR
- Organization
- Alcon Research, Ltd.
Study Officials
- STUDY DIRECTOR
Sr Clinical Manager, GCRA-Global Med Affairs, Operations
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2014
First Posted
August 19, 2014
Study Start
October 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 26, 2016
Results First Posted
May 26, 2016
Record last verified: 2016-04