Effect of Blue Light Filtration on Visual Performance

January 14, 2015 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Clear, then Blue Light Filter
Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
Device: Clear clip-on glasses
Clip-on glasses with no light filtering properties
Device: Blue light filter clip-on glasses
Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs
Other: Blue Light Filter, then Clear
Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
Device: Clear clip-on glasses
Clip-on glasses with no light filtering properties
Device: Blue light filter clip-on glasses
Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Stefani Smith, MS, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A01311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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