Effect of Blue Light Filtration on Visual Performance

NCT ID: NCT01938989

Last Updated: 2015-01-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Clear, then Blue Light Filter

Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction

Group Type OTHER

Clear clip-on glasses

Intervention Type DEVICE

Clip-on glasses with no light filtering properties

Blue light filter clip-on glasses

Intervention Type DEVICE

Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs

Blue Light Filter, then Clear

Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction

Group Type OTHER

Clear clip-on glasses

Intervention Type DEVICE

Clip-on glasses with no light filtering properties

Blue light filter clip-on glasses

Intervention Type DEVICE

Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs

Interventions

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Clear clip-on glasses

Clip-on glasses with no light filtering properties

Intervention Type DEVICE

Blue light filter clip-on glasses

Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs

Intervention Type DEVICE

Eligibility Criteria

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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;

Exclusion Criteria

* Ocular pathology, degeneration, or media opacity (cloudiness) that could impact study measurements;
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefani Smith, MS

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

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A01311

Identifier Type: -

Identifier Source: org_study_id

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