Effect of Blue Light Filtration on Visual Performance
1 other identifier
interventional
158
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 3, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
January 19, 2015
CompletedJanuary 19, 2015
January 1, 2015
4 months
September 3, 2013
January 14, 2015
January 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 1
Study Arms (2)
Clear, then Blue Light Filter
OTHERClear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
Blue Light Filter, then Clear
OTHERBlue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
Interventions
Clip-on glasses with no light filtering properties
Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs
Eligibility Criteria
You may qualify if:
- Cataract surgery in both eyes with no blue light filtering intraocular lenses for at least 3 months;
- Good ocular health;
- /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;
You may not qualify if:
- Ocular pathology, degeneration, or media opacity (cloudiness) that could impact study measurements;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melvin Sarayba, Franchise Head Cataract, GMA
- Organization
- Alcon Research, Ltd.
Study Officials
- STUDY DIRECTOR
Stefani Smith, MS
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2013
First Posted
September 11, 2013
Study Start
September 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
January 19, 2015
Results First Posted
January 19, 2015
Record last verified: 2015-01