Effect of Blue Light Filtration on Visual Performance

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01938989
• Collaborator: (none)
• Enrollment: 158
• Arms: 2
• Duration (Months): 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Clear clip-on glasses; Device: Blue light filter clip-on glasses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Effect of Blue Light Filtration on Visual Performance
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Stefani Smith, MS, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01938989
• Other Study ID Numbers: A01311
• First Posted: Sep 11, 2013
• Last Update Posted: Jan 19, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Alcon Research: cataract; intraocular lens; IOL; blue light filter
• Additional relevant MeSH terms: Cataract; Methamphetamine; beta-Endorphin; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 6 study sites located in the US.
Pre-assignment Detail	Of the 158 enrolled, 2 participants were exited as screen failures prior to randomization. This reporting group includes all randomized and treated participants (154). Note: 2 participants were randomized but not treated.

Arm/Group Title	Clear, Then Blue Light Filter	Blue Light Filter, Then Clear
Arm/Group Description	Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction	Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
Period Title: Overall Study
STARTED	77	77
COMPLETED	77	77
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Blue light filter clip-on glasses and clear clip-on glasses worn over habitual correction in a crossover assignment.
Overall Participants	156
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.9 (8.04)
Sex: Female, Male (Count of Participants)
Female	91 58.3%
Male	65 41.7%

Outcome Measures

1. Primary Outcome

Title	Photostress Recovery Time
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

This analysis population includes all participants with observation minus any major protocol deviations.

Arm/Group Title	Blue Light Filter	Clear
Arm/Group Description	Blue light filter clip-on glasses worn over habitual correction	Clear clip-on glasses worn over habitual correction
Measure Participants	145	144
Mean (Standard Deviation) [seconds]	5.66 (6.20)	6.94 (7.16)

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (30 Sep 2013 to 22 Jan 2014). This analysis group includes all enrolled participants.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. Reports of AEs were obtained through volunteered and elicited comments from the subjects.
Arm/Group Title	Blue Light Filter		Clear
Arm/Group Description	Blue light filter clip-on glasses worn over habitual correction		Clear clip-on glasses worn over habitual correction
All Cause Mortality
	Blue Light Filter		Clear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Blue Light Filter		Clear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/158 (0%)		0/158 (0%)
Other (Not Including Serious) Adverse Events
	Blue Light Filter		Clear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/158 (0%)		0/158 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.