Effect of Blue Light Filtration on Visual Performance

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Clear clip-on glasses; Device: Blue light filter clip-on glasses

• Registration Number: NCT01938989
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate photostress recovery with blue light filter clip-on glasses among pseudophakes \[ie, subjects in which the natural lens of the eye has been replaced with an artificial lens (intraocular lens) during cataract surgery\]. This study will enroll subjects previously implanted with no blue light filter intraocular lenses (IOLs) for at least 3 months.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-11
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-01
• Results First Submitted: 2015-01-14
• Results First Submitted QC: 2015-01-14
• Last Update Submitted: 2015-01-14
• Results First Posted: 2015-01-19
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• 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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Blue Light Filter, then Clear	Blue light filter clip-on glasses	Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
Clear, then Blue Light Filter	Clear clip-on glasses	Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
Clear, then Blue Light Filter	Blue light filter clip-on glasses	Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
Blue Light Filter, then Clear	Clear clip-on glasses	Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction

Primary Outcome Measures

Name	Time	Method
Photostress Recovery Time	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.