Effects of Blue-light Blocking Lens on Visual FunctionsNCT02821403

Effects of Blue-light Blocking Lens on Visual Functions

A study testing clear lens with regular coating, regular coating lens with yellow tint and clear lens with blue-light blocking coating in people with Effects of Blue-light Blocking Lens on Visual Functions, run by The Hong Kong Polytechnic University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Effects of Blue-light Blocking Lens on Visual Functions
What is being tested?: clear lens with regular coating, regular coating lens with yellow tint and clear lens with blue-light blocking coating
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: Jul 2014to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

age: 18 to 35 years OR 40 to 55 years
daily computer usage over over 2 hours per day

Who cannot join

visual acuity worst than 0 logMAR
abnormal binocular and color vision
previous history of ocular surgeries

About this study

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.

Conditions: Effects of Blue-light Blocking Lens on Visual Functions
Being tested: clear lens with regular coating, regular coating lens with yellow tint, clear lens with blue-light blocking coating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

clear lens with regular coatingDevice
regular coating lens with yellow tintDevice
clear lens with blue-light blocking coatingDevice

Study groups in NCT02821403
Study group	Role	What they receive
Young adults	Experimental	adults without presbyopia who aged 18-35 years Receives: Device: clear lens with regular coating; Device: regular coating lens with yellow tint; Device: clear lens with blue-light blocking coating
Middle-aged adults	Experimental	adults with presbyopia who aged over 40 years Receives: Device: clear lens with regular coating; Device: regular coating lens with yellow tint; Device: clear lens with blue-light blocking coating

What is being measured

The primary outcome is the main question the study is designed to answer.

Contrast Sensitivity as Assessed by Mars Contrast Sensitivity Chart
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.
Measured: Every 1-month interval from the date of randomization, up to 3 months
Color Vision as Assessed by the Farnsworth Munsell 100 Hue Test
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.
Measured: Every 1-month interval from the date of randomization, up to 3 months

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014May 2015

First posted1 Jul 2016 (estimated)
Study startJul 2014
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Effects of Blue-light Blocking Lens on Visual FunctionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02821403
Sponsor's protocol ID: HSEARS20140512001-03
Status last verified: Jun 2016
First submitted: 27 Jun 2016
Last updated: 7 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Wu J, Seregard S, Algvere PV. Photochemical damage of the retina. Surv Ophthalmol. 2006 Sep-Oct;51(5):461-81. doi: 10.1016/j.survophthal.2006.06.009.
PubMed 16950247
Taylor HR, Munoz 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.
PubMed 2095019
Ham WT Jr, Mueller HA, Sliney DH. Retinal sensitivity to damage from short wavelength light. Nature. 1976 Mar 11;260(5547):153-5. doi: 10.1038/260153a0. No abstract available.
PubMed 815821
WALD G. THE RECEPTORS OF HUMAN COLOR VISION. Science. 1964 Sep 4;145(3636):1007-16. doi: 10.1126/science.145.3636.1007. No abstract available.
PubMed 14172613
Aggarwala KR, Nowbotsing S, Kruger PB. Accommodation to monochromatic and white-light targets. Invest Ophthalmol Vis Sci. 1995 Dec;36(13):2695-705.
PubMed 7499092
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.
PubMed 8594811
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. No abstract available.
PubMed 19547745
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. doi: 10.1210/jc.2003-030570.
PubMed 12970330
Leung TW, Li RW, Kee CS. Blue-Light Filtering Spectacle Lenses: Optical and Clinical Performances. PLoS One. 2017 Jan 3;12(1):e0169114. doi: 10.1371/journal.pone.0169114. eCollection 2017.
PubMed 28045969

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Blue-light Blocking Lens on Visual Functions
ClinicalTrials.gov ID: NCT02821403
Acronym / sponsor ID: HSEARS20140512001-03
Conditions: Effects of Blue-light Blocking Lens on Visual Functions
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: Jul 2014
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 1 Jul 2016 (estimated)
Results: Posted 7 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Young adults	Experimental	Device: clear lens with regular coating, Device: regular coating lens with yellow tint, Device: clear lens with blue-light blocking coatingadults without presbyopia who aged 18-35 years
Middle-aged adults	Experimental	Device: clear lens with regular coating, Device: regular coating lens with yellow tint, Device: clear lens with blue-light blocking coatingadults with presbyopia who aged over 40 years

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

age: 18 to 35 years OR 40 to 55 years
daily computer usage over over 2 hours per day

Key exclusion criteria (3 listed)

visual acuity worst than 0 logMAR
abnormal binocular and color vision
previous history of ocular surgeries

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
clear lens with regular coating	Device	Middle-aged adults, Young adults
regular coating lens with yellow tint	Device	Middle-aged adults, Young adults
clear lens with blue-light blocking coating	Device	Middle-aged adults, Young adults

Primary outcome

Contrast Sensitivity as Assessed by Mars Contrast Sensitivity Chart
Time frame: 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.
Color Vision as Assessed by the Farnsworth Munsell 100 Hue Test
Time frame: 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.

1 secondary outcome

Self-assessment of Lens Performance Through Questionnaire
Time frame: Every 1-month interval from the date of randomization, up to 3 months

Results and safety

Results posted to the registry on 7 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Young Adults	40	40
Middle-aged Adults	40	40

Primary outcome: Contrast Sensitivity as Assessed by Mars Contrast Sensitivity Chart

Time frame: Every 1-month interval from the date of randomization, up to 3 months. Mean (Standard Error). Unit: log contrast sensitivity score

Measure	Young Adults: Clear Lens With Regular Coating n = 40	Young Adults: Regular Coating Lens With Yellow Tint n = 40	Young Adults: Clear Lens With Blue-light Blocking Coating n = 40	Middle-aged Adults: Clear Lens With Regular Coating n = 40	Middle-aged Adults: Regular Coating Lens With Yellow Tint n = 40	Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin n = 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)

Primary outcome: Color Vision as Assessed by the Farnsworth Munsell 100 Hue Test

Time frame: Every 1-month interval from the date of randomization, up to 3 months. Mean (Standard Error). Unit: units on a scale

Measure	Young Adults: Clear Lens With Regular Coating n = 40	Young Adults: Regular Coating Lens With Yellow Tint n = 40	Young Adults: Clear Lens With Blue-light Blocking Coating n = 40	Middle-aged Adults: Clear Lens With Regular Coating n = 40	Middle-aged Adults: Regular Coating Lens With Yellow Tint n = 40	Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin n = 40
Value	30.8 (3.34)	33.3 (3.36)	30.1 (3.00)	49.1 (5.49)	54.65 (4.66)	52.4 (5.21)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Young Adults	0 of 0	0 of 0	Not reported
Middle-aged Adults	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16950247Wu J, Seregard S, Algvere PV. Photochemical damage of the retina. Surv Ophthalmol. 2006 Sep-Oct;51(5):461-81. doi: 10.1016/j.survophthal.2006.06.009.
Background: PubMed 2095019Taylor HR, Munoz 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.
Background: PubMed 815821Ham WT Jr, Mueller HA, Sliney DH. Retinal sensitivity to damage from short wavelength light. Nature. 1976 Mar 11;260(5547):153-5. doi: 10.1038/260153a0. No abstract available.
Background: PubMed 14172613WALD G. THE RECEPTORS OF HUMAN COLOR VISION. Science. 1964 Sep 4;145(3636):1007-16. doi: 10.1126/science.145.3636.1007. No abstract available.
Background: PubMed 7499092Aggarwala KR, Nowbotsing S, Kruger PB. Accommodation to monochromatic and white-light targets. Invest Ophthalmol Vis Sci. 1995 Dec;36(13):2695-705.
Background: PubMed 8594811Kruger 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.
Background: PubMed 19547745Dijk 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. No abstract available.
Background: PubMed 12970330Lockley 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. doi: 10.1210/jc.2003-030570.
Derived from this study: PubMed 28045969Leung TW, Li RW, Kee CS. Blue-Light Filtering Spectacle Lenses: Optical and Clinical Performances. PLoS One. 2017 Jan 3;12(1):e0169114. doi: 10.1371/journal.pone.0169114. eCollection 2017.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contrast Sensitivity as Assessed by Mars Contrast Sensitivity Chart (time frame: Every 1-month interval from the date of randomization, up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02821403, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.