Effect of Blue Light Filtration on Visual Performance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01938989
First received: September 3, 2013
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to demonstrate improved 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.


Condition Intervention
Cataract
Device: Clear clip-on glasses
Device: Blue light filter clip-on glasses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of Blue Light Filtration on Visual Performance

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Photostress Recovery [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The subject will fixate on an image (black and white grating) and undergo photostress (glare) for 5 seconds. The time necessary to recover central visibility of the grating will be measured in seconds and minutes. Only one eye will be assessed.


Enrollment: 159
Study Start Date: September 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938989

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Stefani Smith, MS Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01938989     History of Changes
Other Study ID Numbers: A01311
Study First Received: September 3, 2013
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
cataract
intraocular lens
IOL
blue light filter

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014