CataractNCT01938989

Effect of Blue Light Filtration on Visual Performance

A study testing Clear clip-on glasses and Blue light filter clip-on glasses 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

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Trial summary

The purpose of this study is to evaluate photostress recovery with blue light filter clip-on glasses among pseudophakes [ie, subjects in which the natural lens of the eye has been replaced with an artificial lens (intraocular lens) during cataract surgery]. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Cataract
What is being tested?: Clear clip-on glasses and Blue light filter clip-on glasses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: No sites listed yet
Study dates: Sep 2013to Jan 2014
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Cataract surgery in both eyes with no blue light filtering intraocular lenses for at least 3 months;
Good ocular health;
20/40 or better vision with best correction in both eyes;
Willing to provide voluntary consent and sign informed consent form;
Able to competently perform testing;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Ocular pathology, degeneration, or media opacity (cloudiness) that could impact study measurements;
Other protocol-defined exclusion criteria may apply.

About this study

Conditions: Cataract
Being tested: Clear clip-on glasses, Blue light filter clip-on glasses
Keywords: cataract, intraocular lens, IOL, blue light filter
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 light filtering properties
Blue light filter clip-on glassesDevice
Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs

Study groups in NCT01938989
Study group	Role	What they receive
Clear, then Blue Light Filter	Other	Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction Receives: Device: Clear clip-on glasses; Device: Blue light filter clip-on glasses
Blue Light Filter, then Clear	Other	Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction Receives: Device: Clear clip-on glasses; Device: Blue light filter clip-on glasses

What is being measured

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

Photostress Recovery Time
Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed.
Measured: Day 1

Timeline

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

Sep 2013Jan 2014

First posted11 Sep 2013 (estimated)
Study startSep 2013
Primary completionJan 2014
Study completionJan 2014

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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01938989
Sponsor's protocol ID: A01311
Status last verified: Jan 2015
First submitted: 3 Sep 2013
Last updated: 19 Jan 2015
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

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Blue Light Filtration on Visual Performance
ClinicalTrials.gov ID: NCT01938989
Acronym / sponsor ID: A01311
Conditions: Cataract
Keywords: cataract, intraocular lens, IOL, blue light filter
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 11 Sep 2013 (estimated)
Results: Posted 19 Jan 2015

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Clear, then Blue Light Filter	Other	Device: Clear clip-on glasses, Device: Blue light filter clip-on glassesClear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
Blue Light Filter, then Clear	Other	Device: Clear clip-on glasses, Device: Blue light filter clip-on glassesBlue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Cataract surgery in both eyes with no blue light filtering intraocular lenses for at least 3 months;
Good ocular health;
20/40 or better vision with best correction in both eyes;
Willing to provide voluntary consent and sign informed consent form;
Able to competently perform testing;

Key exclusion criteria (2 listed)

Ocular pathology, degeneration, or media opacity (cloudiness) that could impact study measurements;
Other protocol-defined 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 light filtering properties	Device	Blue Light Filter, then Clear, Clear, then Blue Light Filter
Blue light filter clip-on glassesClip-on glasses with blue light filtering properties equivalent to AcrySof IOLs	Device	Blue Light Filter, then Clear, Clear, then Blue Light Filter

Primary outcome

Photostress Recovery Time
Time frame: Day 1
Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed.

Results and safety

Results posted to the registry on 19 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clear, Then Blue Light Filter	77	77
Blue Light Filter, Then Clear	77	77

Primary outcome: Photostress Recovery Time

Time frame: Day 1. Mean (Standard Deviation). Unit: seconds

Measure	Blue Light Filter n = 145	Clear n = 144
Value	5.66 (6.20)	6.94 (7.16)

Population analysed: This analysis population includes all participants with observation minus any major protocol deviations.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (30 Sep 2013 to 22 Jan 2014). This analysis group includes all enrolled participants.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Blue Light Filter	0 of 158 (0%)	0 of 158 (0%)	Not reported
Clear	0 of 158 (0%)	0 of 158 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataract

RecruitingObservational study
Capella Scientia Development Study
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Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
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Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
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RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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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.

Stefani Smith, MS study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Clear clip-on glasses and Blue light filter clip-on glasses 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 2 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 19 Jan 2015. 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 19 Jan 2015). 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?

Photostress Recovery Time (time frame: Day 1). 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 NCT01938989.

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 19 Jan 2015.