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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young adults | Experimental | adults without presbyopia who aged 18-35 years |
|
| Middle-aged adults | Experimental | adults with presbyopia who aged over 40 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clear lens with regular coating | Device |
| ||
| regular coating lens with yellow tint |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Every 1-month interval from the date of randomization, up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16950247 | Background | 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. | |
| 2095019 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Young Adults | 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. |
| FG001 | Middle-aged Adults | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| "First Intervention (1 Month)" |
| ||||||||||||||||||||||
| "Second Intervention (1 Month)" |
| ||||||||||||||||||||||
| "Third Intervention (1 Month)" |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Young Adults | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | log contrast sensitivity score | Every 1-month interval from the date of randomization, up to 3 months |
|
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There was no foreseeable safety issue and adverse effect. Serious and Other [Not Including Serious] Adverse Events were not collected/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Young Adults | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tsz Wing Leung | The Hong Kong Polytechnic University | 27664268 | jeffrey.TW.leung@polyu.edu.hk |
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| Device |
|
| clear lens with blue-light blocking coating | Device |
|
| Every 1-month interval from the date of randomization, up to 3 months |
| 815821 | Background | 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. |
| 14172613 | Background | 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. |
| 7499092 | Background | Aggarwala KR, Nowbotsing S, Kruger PB. Accommodation to monochromatic and white-light targets. Invest Ophthalmol Vis Sci. 1995 Dec;36(13):2695-705. |
| 8594811 | Background | 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. |
| 19547745 | Background | 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. |
| 12970330 | Background | 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. |
| 28045969 | Derived | 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. |
| Used Yellow Tinted Lens |
|
| Used Blue-filtering Coated Lens |
|
| COMPLETED |
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| NOT COMPLETED |
|
| Used Yellow Tinted Lens |
|
| Used Blue-filtering Coated Lens |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Middle-aged Adults | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Young Adults: Clear Lens With Regular Coating |
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. |
| OG001 | Young Adults: Regular Coating Lens With Yellow Tint | 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. |
| OG002 | Young Adults: Clear Lens With Blue-light Blocking Coating | 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. |
| OG003 | Middle-aged Adults: Clear Lens With Regular Coating | 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. |
| OG004 | Middle-aged Adults: Regular Coating Lens With Yellow Tint | 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. |
| OG005 | Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin | 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. |
|
|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | Every 1-month interval from the date of randomization, up to 3 months |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | Every 1-month interval from the date of randomization, up to 3 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Middle-aged Adults | 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 | 0 | 0 | 0 | 0 |
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| clear lens with blue-light blocking coating |
|