Effects of Blue-light Blocking Lens on Visual Functions

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02821403
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Duration (Months): 10

Study Details

Study Description

Brief Summary

Working Hypothesis: The blue-light blocking lens has no effect on the contrast sensitivity, accommodative response, color vision, and subjective grading of the quality of life and vision.

Purpose: To determine and compare the visual performances after wearing the blue-light blocking lenses in participants with and without presbyopia.

Methods: One hundred and sixty computer users (computer usage >2 hours/day) with (n=120, aged

40years) and without presbyopia (n=40, aged 18-35 years) will be recruited. Three pairs of ophthalmic lenses will be prescribed for the participants, in which one pair of them will be the blue-light blocking lenses (StressFree, Swisscoat, HK). The lenses will be used for intermediate vision (i.e., computer usage) in presbyopic group, and for distant vision in non-presbyopic group. The adaptation period for each pair of lenses will be 1 month. The pre- and post-treatment contrast sensitivity, accommodative response and color vision will be measured. The participants will also be asked to complete questionnaires about their quality of life and vision, and the performances of these ophthalmic lenses.

Significance: The blue-light blocking lens reflects the short-wavelength lights and protects the retina from "blue-light hazards"; however, blue lights are essential for various visual function and circadian rhythms. This study will evaluate the impact of the blue-light blocking lenses on visual function and quality of life, and determine whether the blue-light blocking lenses are good choices for extra ocular protection.

Condition or Disease	Intervention/Treatment	Phase
Effects of Blue-light Blocking Lens on Visual Functions	Device: clear lens with regular coating; Device: regular coating lens with yellow tint; Device: clear lens with blue-light blocking coating	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Young adults adults without presbyopia who aged 18-35 years	Device: clear lens with regular coating; Device: regular coating lens with yellow tint; Device: clear lens with blue-light blocking coating
Experimental: Middle-aged adults adults with presbyopia who aged over 40 years	Device: clear lens with regular coating; Device: regular coating lens with yellow tint; Device: clear lens with blue-light blocking coating

Outcome Measures

Primary Outcome Measures

1. Contrast Sensitivity as Assessed by Mars Contrast Sensitivity Chart [Every 1-month interval from the date of randomization, up to 3 months]

   Contrast sensitivity was measured using the Mars contrast sensitivity letter chart (Mars Perceptrix, Chappaqua, NY). One out of three charts differing in the letter combinations was selected randomly in order to avoid memorization of the charts. The chart was placed at 50 cm with each letter subtended 2° visual angle. We followed the recording procedures as specified by the manufacturer: participants were instructed to read the letters from high to low contrasts and the test ended when two consecutive errors were made. The contrast sensitivity was scored as the log contrast sensitivity of the last correct letter minus 0.04 log unit for every prior error. The test was administered under normal (room illumination, 400 lux) and glare conditions. A brightness acuity tester set at its medium light intensity level (100 foot lamberts) simulated the glaring condition. A higher mean indicates improved contrast sensitivity.

2. Color Vision as Assessed by the Farnsworth Munsell 100 Hue Test [Every 1-month interval from the date of randomization, up to 3 months]

   The Farnsworth Munsell 100 hue test (X-Rite, USA) was used to evaluate colour vision. Each of the four trays consisted of 21 movable caps. Participants were asked to sort the randomly arranged caps following the hue order from the first to the last fixed caps. The total error score was calculated, as documented in the instruction manual, to quantify the accuracy of color discrimination. There are no defined endpoints to the "total error score" range. A lower score indicates improved color discrimination ability.

Secondary Outcome Measures

1. Self-assessment of Lens Performance Through Questionnaire [Every 1-month interval from the date of randomization, up to 3 months]

   After each monthly wearing period (visits 3-5), the participants' lens performance, night vision quality and sleep quality (total 13 questions) were assessed subjectively using a questionnaire (scoring from 1 [very unsatisfactory] to 5 [very satisfactory]). At the end of the study, the participants were asked to choose their preferred lens type among the three pairs of lenses based on their subjective feeling of the "best lens type" (i.e., either clear lens, yellow tinted lens or blue-filtering coated lens). To make it clear and simple, here we only present the data on the participants choice of their preferred lens type (i.e., simply choosing the "best lens" among clear lens, yellow tinted lens or blue-filtering coated lens).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age: 18 to 35 years OR 40 to 55 years

• daily computer usage over over 2 hours per day

Exclusion Criteria:

• visual acuity worst than 0 logMAR

• abnormal binocular and color vision

• previous history of ocular surgeries

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The Hong Kong Polytechnic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Aggarwala KR, Nowbotsing S, Kruger PB. Accommodation to monochromatic and white-light targets. Invest Ophthalmol Vis Sci. 1995 Dec;36(13):2695-705.
• Dijk DJ, Archer SN. Light, sleep, and circadian rhythms: together again. PLoS Biol. 2009 Jun 16;7(6):e1000145. doi: 10.1371/journal.pbio.1000145. Epub 2009 Jun 23.
• Ham WT Jr, Mueller HA, Sliney DH. Retinal sensitivity to damage from short wavelength light. Nature. 1976 Mar 11;260(5547):153-5.
• Kruger PB, Mathews S, Aggarwala KR, Yager D, Kruger ES. Accommodation responds to changing contrast of long, middle and short spectral-waveband components of the retinal image. Vision Res. 1995 Sep;35(17):2415-29. doi: 10.1016/0042-6989(94)00316-5. Erratum in: Vision Res 1996 Jul;36(13):2014.
• Lockley SW, Brainard GC, Czeisler CA. High sensitivity of the human circadian melatonin rhythm to resetting by short wavelength light. J Clin Endocrinol Metab. 2003 Sep;88(9):4502-5.
• Taylor HR, Muñoz B, West S, Bressler NM, Bressler SB, Rosenthal FS. Visible light and risk of age-related macular degeneration. Trans Am Ophthalmol Soc. 1990;88:163-73; discussion 173-8.
• WALD G. THE RECEPTORS OF HUMAN COLOR VISION. Science. 1964 Sep 4;145(3636):1007-16.
• Wu J, Seregard S, Algvere PV. Photochemical damage of the retina. Surv Ophthalmol. 2006 Sep-Oct;51(5):461-81. Review.

• Responsible Party: The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT02821403
• Other Study ID Numbers: HSEARS20140512001-03
• First Posted: Jul 1, 2016
• Last Update Posted: Apr 7, 2017
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided

Study Results

Participant Flow

Arm/Group Title	Young Adults	Middle-aged Adults
Arm/Group Description	adults without presbyopia who aged 18-35 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. Cross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.	adults with presbyopia who aged over 40 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. Cross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.
Period Title: "First Intervention (1 Month)"
STARTED	40	40
Used Clear Lens	13	13
Used Yellow Tinted Lens	13	14
Used Blue-filtering Coated Lens	14	13
COMPLETED	40	40
NOT COMPLETED	0	0
Period Title: "First Intervention (1 Month)"
STARTED	40	40
Used Clear Lens	13	14
Used Yellow Tinted Lens	14	13
Used Blue-filtering Coated Lens	13	13
COMPLETED	40	40
NOT COMPLETED	0	0
Period Title: "First Intervention (1 Month)"
STARTED	40	40
Used Clear Lens	14	13
Used Yellow Tinted Lens	13	13
Used Blue-filtering Coated Lens	13	14
COMPLETED	40	40
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Young Adults	Middle-aged Adults	Total
Arm/Group Description	adults without presbyopia who aged 18-35 years Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating	adults with presbyopia who aged over 40 years Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating	Total of all reporting groups
Overall Participants	40	40	80
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	40 100%	40 100%	80 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	21 52.5%	29 72.5%	50 62.5%
Male	19 47.5%	11 27.5%	30 37.5%

Outcome Measures

1. Primary Outcome

Title	Contrast Sensitivity as Assessed by Mars Contrast Sensitivity Chart
Description	Contrast sensitivity was measured using the Mars contrast sensitivity letter chart (Mars Perceptrix, Chappaqua, NY). One out of three charts differing in the letter combinations was selected randomly in order to avoid memorization of the charts. The chart was placed at 50 cm with each letter subtended 2° visual angle. We followed the recording procedures as specified by the manufacturer: participants were instructed to read the letters from high to low contrasts and the test ended when two consecutive errors were made. The contrast sensitivity was scored as the log contrast sensitivity of the last correct letter minus 0.04 log unit for every prior error. The test was administered under normal (room illumination, 400 lux) and glare conditions. A brightness acuity tester set at its medium light intensity level (100 foot lamberts) simulated the glaring condition. A higher mean indicates improved contrast sensitivity.
Time Frame	Every 1-month interval from the date of randomization, up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Young Adults: Clear Lens With Regular Coating	Young Adults: Regular Coating Lens With Yellow Tint	Young Adults: Clear Lens With Blue-light Blocking Coating	Middle-aged Adults: Clear Lens With Regular Coating	Middle-aged Adults: Regular Coating Lens With Yellow Tint	Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin
Arm/Group Description	adults without presbyopia who aged 18-35 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.	adults without presbyopia who aged 18-35 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.	adults without presbyopia who aged 18-35 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.	adults with presbyopia who aged over 40 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.	adults with presbyopia who aged over 40 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.	adults with presbyopia who aged over 40 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.
Measure Participants	40	40	40	40	40	40
without glare	1.866 (0.004)	1.861 (0.005)	1.856 (0.008)	1.818 (0.014)	1.799 (0.016)	1.802 (0.013)
with glare	1.817 (0.015)	1.802 (0.032)	1.777 (0.035)	1.759 (0.019)	1.768 (0.018)	1.785 (0.017)

2. Primary Outcome

Title	Color Vision as Assessed by the Farnsworth Munsell 100 Hue Test
Description	The Farnsworth Munsell 100 hue test (X-Rite, USA) was used to evaluate colour vision. Each of the four trays consisted of 21 movable caps. Participants were asked to sort the randomly arranged caps following the hue order from the first to the last fixed caps. The total error score was calculated, as documented in the instruction manual, to quantify the accuracy of color discrimination. There are no defined endpoints to the "total error score" range. A lower score indicates improved color discrimination ability.
Time Frame	Every 1-month interval from the date of randomization, up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Young Adults: Clear Lens With Regular Coating	Young Adults: Regular Coating Lens With Yellow Tint	Young Adults: Clear Lens With Blue-light Blocking Coating	Middle-aged Adults: Clear Lens With Regular Coating	Middle-aged Adults: Regular Coating Lens With Yellow Tint	Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin
Arm/Group Description	adults without presbyopia who aged 18-35 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.	adults without presbyopia who aged 18-35 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.	adults without presbyopia who aged 18-35 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.	adults with presbyopia who aged over 40 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.	adults with presbyopia who aged over 40 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.	adults with presbyopia who aged over 40 years Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating. The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.
Measure Participants	40	40	40	40	40	40
Mean (Standard Error) [units on a scale]	30.8 (3.34)	33.3 (3.36)	30.1 (3.00)	49.1 (5.49)	54.65 (4.66)	52.4 (5.21)

3. Secondary Outcome

Title	Self-assessment of Lens Performance Through Questionnaire
Description	After each monthly wearing period (visits 3-5), the participants' lens performance, night vision quality and sleep quality (total 13 questions) were assessed subjectively using a questionnaire (scoring from 1 [very unsatisfactory] to 5 [very satisfactory]). At the end of the study, the participants were asked to choose their preferred lens type among the three pairs of lenses based on their subjective feeling of the "best lens type" (i.e., either clear lens, yellow tinted lens or blue-filtering coated lens). To make it clear and simple, here we only present the data on the participants choice of their preferred lens type (i.e., simply choosing the "best lens" among clear lens, yellow tinted lens or blue-filtering coated lens).
Time Frame	Every 1-month interval from the date of randomization, up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Young Adults	Middle-aged Adults
Arm/Group Description	adults without presbyopia who aged 18-35 years Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating	adults with presbyopia who aged over 40 years Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating
Measure Participants	40	40
clear lens with regular coating	20 50%	9 22.5%
regular coating lens with yellow tint	1 2.5%	7 17.5%
clear lens with blue-light blocking coating	19 47.5%	24 60%

Adverse Events

Adverse Event Reporting Description	There was no foreseeable safety issue and adverse effect. Serious and Other [Not Including Serious] Adverse Events were not collected/assessed.
Arm/Group Title	Young Adults		Middle-aged Adults
Arm/Group Description	adults without presbyopia who aged 18-35 years Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating		adults with presbyopia who aged over 40 years Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating
All Cause Mortality
	Young Adults		Middle-aged Adults
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Young Adults		Middle-aged Adults
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Young Adults		Middle-aged Adults
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.