N/A
N=68
Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT02219997 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Change in Braking Reaction Time From No-glare to Glare — 0.07; 0.15 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clear clip-on glasses (Device); Blue light filter clip-on glasses (Device); ACRYSOF® IQ IOL (Device); Clear IOL (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Braking Reaction Time From No-glare to Glare |
0.07; 0.15 | — |
| SECONDARY Change in Braking Reaction Time From No-glare to Glare (Clear IOLs) |
0.17; 0.16 | — |
| SECONDARY Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF) |
0.12; 0.16 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02219997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.