CataractNCT02219997

Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration

A study testing Clear clip-on glasses, Blue light filter clip-on glasses and ACRYSOF® IQ IOL in people with Cataract, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 65 to 75 years
Conditions the study is for: Cataract
What is being tested?: Clear clip-on glasses, Blue light filter clip-on glasses and ACRYSOF® IQ IOL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: No sites listed yet
Study dates: Oct 2014to Mar 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 75 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

Official title: Functional Benefit With ACRYSOF® Natural Chromophore

Read the detailed description

Subjects completed 2 visits to the investigational site.

Conditions: Cataract
Being tested: Clear clip-on glasses, Blue light filter clip-on glasses, ACRYSOF® IQ IOL, Clear IOL
Keywords: Cataract, Intraocular lens (IOL), AcrySof
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clear clip-on glassesDevice
Clip-on glasses with no blue light filtering properties used as a placebo
Blue light filter clip-on glassesDevice
Clip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs
ACRYSOF® IQ IOLDevice
AcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted
Clear IOLDevice
Clear IOL, previously implanted

Study groups in NCT02219997
Study group	Role	What they receive
ACRYSOF IQ IOL	Experimental	ACRYSOF® IQ IOL with or without clear clip-on glasses worn for 3 hours Receives: Device: Clear clip-on glasses; Device: ACRYSOF® IQ IOL
Clear IOL	Active comparator	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 Receives: Device: Clear clip-on glasses; Device: Blue light filter clip-on glasses; Device: Clear IOL

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Visit 2, up to Day 30

Secondary outcomes (2)

Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)
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.
Measured: Visit 2, Up to Day 30
Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)
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.
Measured: Visit 2, Up to Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Mar 2015

First posted19 Aug 2014 (estimated)
Study startOct 2014
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02219997
Sponsor's protocol ID: ILQ830-P001
Status last verified: Apr 2016
First submitted: 18 Aug 2014
Last updated: 26 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
Cataract
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy

All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Functional Benefit With ACRYSOF® Natural Chromophore
ClinicalTrials.gov ID: NCT02219997
Acronym / sponsor ID: ILQ830-P001
Conditions: Cataract
Keywords: Cataract, Intraocular lens (IOL), AcrySof
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 19 Aug 2014 (estimated)
Results: Posted 26 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects completed 2 visits to the investigational site.

Study design

Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
ACRYSOF IQ IOL	Experimental	Device: Clear clip-on glasses, Device: ACRYSOF® IQ IOLACRYSOF® IQ IOL with or without clear clip-on glasses worn for 3 hours
Clear IOL	Active comparator	Device: Clear clip-on glasses, Device: Blue light filter clip-on glasses, Device: Clear IOLClear 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

Who may qualify

Ages: 65 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clear clip-on glassesClip-on glasses with no blue light filtering properties used as a placebo	Device	ACRYSOF IQ IOL, Clear IOL
Blue light filter clip-on glassesClip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs	Device	Clear IOL
ACRYSOF® IQ IOLAcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted	Device	ACRYSOF IQ IOL
Clear IOLClear IOL, previously implanted	Device	Clear IOL

Primary outcome

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.

2 secondary outcomes

Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)
Time frame: 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

Results and safety

Results posted to the registry on 26 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AcrySof IQ IOL	33	33
Clear IOL: BLF First, Then Placebo Filter	17	17
Clear IOL: Placebo Filter First, Then BLF	18	18

Primary outcome: Change in Braking Reaction Time From No-glare to Glare

Time frame: Visit 2, up to Day 30. Mean (Standard Deviation). Unit: seconds

Measure	AcrySof IQ IOL n = 33	Clear IOL n = 33
Value	0.07 (0.12)	0.15 (0.21)

Population analysed: This analysis population includes subjects who were reaction tested with no major protocol violations (per protocol).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 30 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-treatment	0 of 90 (0%)	0 of 90 (0%)	Not reported
AcrySof IQ IOL	0 of 33 (0%)	0 of 33 (0%)	Not reported
Clear IOL	0 of 35 (0%)	0 of 35 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataract

RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
Cataract
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sr Clinical Manager, GCRA-Global Med Affairs, Operations study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Clear clip-on glasses, Blue light filter clip-on glasses and ACRYSOF® IQ IOL in people with Cataract, run by Alcon Research.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Braking Reaction Time From No-glare to Glare (time frame: Visit 2, up to Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02219997.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.