Clinical trial NCT02925884: Effects of Gunnar Computer Glasses on Viewing Comfort and Performance
Official title: The Effect of Computer Eyewear on Viewing Comfort and Performance in Office Work
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye
Eye Strain
Visual Acuity
Color Perception
Reading
Lead sponsor: Pacific University
Sponsor class: OTHER
Collaborators: name: Gunnar Optiks
First posted: 2016-10-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The proposed study aims to test if Gunnar computer glasses provide any advantages, in comparison to no glasses, on the following aspects in computer-related office work:

* Any enhancement on visual performance of basic visual function, including visual acuity, contrast sensitivity, color discrimination, etc.
* Any enhancement on visual performance of typical office work, including reading, word-spelling check, number searching, or target identification.
* Any benefit in objective viewing comfort measured with viewing distance, blink frequency, post-viewing pupil size.
* Any benefit in subjective viewing comfort reflected on the questionnaire of viewing symptom survey.
* Any benefit in viewing comfort and visual performance with increased environmental ventilation or under strong glare.
* Any benefit in life quality from daily wearing (e.g., better comfort or sleep quality).

Detailed description: \<Introduction\>

When performing near work, one must focus at (accommodate) and point toward (converge) at a closer distance, and constantly re-focus the eyes in order to see small text and images with clarity. Sustaining such efforts can lead to eye fatigue and eye strain, among a host of vision problems. Most visual tasks on a screen also demand heightened visual concentration and this decreases blink rate. Combined with working in a heated or air-conditioned office environment, which leads to over-evaporation of tear film and lipid deficiency, irritation and dryness to the surface of the cornea are expected. Disruptive glare from excessive screen reflection and ambient lighting also deteriorates the image quality and heaps on viewing discomfort. With extensive screen viewing also exacerbate discomfort in people with existing vision problems like eye muscle imbalance, astigmatism, farsightedness and presbyopia. Since technology is almost unavoidable to modern life, preventions should be taken to lessen the total toll on the eyes and visual system. Gunnar computer glasses address the above issues by providing mild yellow tint anti-reflection coating aimed to shield the harmful blue light and lessen strong glare. The glasses also have a small amount of magnification (+0.5 D) to enhance acuity. The curved frame is designed to retain moisture and reduce dry eye symptoms. All these special characters are devised to enhance visual performance and minimize eye fatigue and visual discomfort in digital viewing. The current study aimed to validate the aforementioned benefits.

Gunnar over-the counter (OTC) computer glasses adopt yellow lenses to cut off the active short wavelength and lessen the bright glare, which often induces the detrimental effect caused by excessive illumination or intense scattered reflection. While the general benefit of glare reduction is well received, the benefit on visual performance has been inconclusive. Some studies reported significant enhancement in contrast sensitivity, but some failed to see any improvement on visual acuity and contrast sensitivity, even with color distortion. Without argument, tinted lenses reduce the transmittance of the visible spectrum and change the visible color to a certain degree. However, there has been report that a reduction of the retinal illumination level does not necessarily lead to reduced brightness; instead, the visual system automatically adjusts for the illumination discounting, possibly with the help of increased pupil size. In addition, with the decrement of blue lights arriving to the eyes, both scattered reflection and chromatic aberration are reduced. Together, it is reasonable to believe that the visual acuity, contrast sensitivity, and chromatic discrimination will not suffer and may, instead, benefit from the filter of yellow lenses. These basic visual functions may, in turn, lead to enhancement in general visual performance such as routine office work. These will be tested in the proposed study.

The current study tested if Gunnar's OTC computer glasses provide any advantages, in comparison to no glasses, on the following aspects in computer-related office work:

* Any enhancement on visual performance of basic visual function, including visual acuity, contrast sensitivity, color discrimination, etc.
* Any enhancement on visual performance of typical office work, including reading, word-spelling check, number searching, or target identification.
* Any benefit in preventing from dry eye by measuring the humidity outside and inside the frame (only in the visit with Gunnar glasses) and the tear film break-up time after viewing for a prolonged period of time.
* Any benefit in objective viewing comfort measured with viewing distance, blink frequency, post-viewing pupil size.
* Any benefit in subjective viewing comfort reflected on the questionnaire of viewing symptom survey.
* Any benefit in viewing comfort and visual performance with increased environmental ventilation.
* Any benefit in viewing comfort and visual performance with increased environmental under strong glare.
* Any benefit in life quality from daily wearing (e.g., viewing comfort, sleep quality or quantity due to the amount of stimulation from blue light)?
* Their willingness to purchase (select) the tested Gunnar OTC glasses, and the price willing to pay for.

\<Study design\>

Thirty-four subjects, age 18 to 42, were planned to be recruited. This sample size is based on a priori power analysis with 80% and a medium effect size at alpha equal to 0.05. Subjects will be stratified into 4 age groups. About equal number (8±1) of subjects should have been recruited for each group:

* 18-23 yr old
* 24-29 yr old
* 30-35 yr old
* 36-42 yr old

Each subject was scheduled for 3 visits: Visit 1 for screening and consenting, visit 2 for lab test after treatment 1, and visit 3 for lab test after treatment 2. Between visits was a adaptation period for the assigned treatment.

Visit 1: Screening visit

* Day 1, when a subject first joins the study
* Obtain informed consent and screening measurements (VA, contrast sensitivity, tear film break-up time as dry eye measurement, Dry eye questionnaire (OSDI), viewing symptom survey (VSS), history of dry eye and computer work behavior).
* At the end of the visit, half of the subjects were given a pair of Gunnar OTC glasses for adaptation for 3 - 7 days; the other half were given no treatment. All subjects were told to work in front of computer for at least 4 hour a day, with the assigned glasses if given.

Adaptation 1:

- Starting on Day 1, for 3 to 7 days, subject was asked to work in front of computers for at least 4 hours each day with assigned treatment 1.

Visit 2: Lab test for treatment 1

* On a day between day 4 and day 8 convenient to the subject, subject came to the lab with the assigned glasses condition.
* Baseline measurements will be taken, followed by a few visual tasks under 3 viewing conditions. Subject was asked to fill out the VSS, given a break, before tested on another round of tasks under a different viewing condition.
* The total testing time is about 70 minutes for each condition and about 4 hours to complete the visit.
* The lab testing procedure is described below.
* At the end of visit 2, treatment was alternated for another 3-7 days of adaptation.

Adaptation 2 with treatment 2:

- Starting on the day of Visit 2 after the test, subject adapt to the second treatment (with Gunnar glasses or without any glasses) for another 3 to 7 days.

Visit 3: Lab test for treatment 2

* The same procedure of Visit 2 was repeated.
* Subject was asked to rate their preference of wearing the Gunnar Glasses over no-glasses when performing computer tasks.
* After this visit, the study was completed for the subject.

Details of lab testing procedures:

* The study adopted a crossover design. Each subject went through three viewing conditions (control, bright light, strong ventilating) based on a Latin Square order.

  1. In the control condition, the subject will perform all tasks under regular office lighting (500 lux) and the default lab ventilation condition.
  2. In the bright light condition, the ambient light will be increased to 1500 lux.
  3. In the strong ventilation condition, a ceiling fan will be positioned on top of the subject at the ceiling light location to increase the air flow.

     Visual performance tasks:
* Baseline measurements (10 min): Upon arrival, subject was asked to fill out VSS and OSDI. Measurements of dry eye condition, pupil size, accommodation status, and blink rate were taken as baseline for the visit.
* Under viewing condition 1:

  1. Visual tasks (60 minutes): Visual acuity, contrast sensitivity, color perception, visual search of numbers among a number matrix, low-contrast target search, text reading, and spelling check were performed by a fixed order.
  2. Post-task measurements of dry eye measure (Tear break up time), pupil size, accommodation, and blink rate as well as VSS were taken.
* Break time of 5-10 minutes.
* Repeat the above procedures for the other two viewing conditions.
* Total time for one lab visit was about 4 hours.

Eligibility criteria: Inclusion Criteria:

* Subjects must be in the age between 18 to 42 years old.
* Subjects must have normal color vision (be able to identify the numbers in the color blind test.
* Subjects' near and far visual acuity with the better eye needs to be 20/25 (measured with a vision chart or better). Subjects can wear contact lenses (but not glasses) if usually wear them while working on computers.
* Subjects must routinely work on a computer or digital display for average 4 hours or more each day.
* Subjects can communicate in English fluently, and are used to read English documents on computer.
* Subjects with existing conditions of dry eye or eye strain will be recorded and serve as a covariate to determine the experimental effect.
* Subjects must have valid tax number or social security number to receive monetary compensation.

Exclusion Criteria:

* The difference on the prescription for both eyes is equal to or larger than 2 Diopters.
* Subjects have cataract or have had cataract surgery.
* Subjects are sensitive to lights (photosensitivity).
* Subjects have prior incidents or are known to have claustrophobia.
* Subjects have been diagnosed with oculomotor diseases or central nervous system diseases, or with developmental, neurological, or psychiatric disorders (e.g., attention deficit hyperactivity disorder, autism, mental retardation).

Primary outcomes:
measure: Subjective rating of Gunnar computer glasses preference
timeFrame: Measurement was taken at the end of the study for each subject, up to 16 days. Data collection and preliminary analysis has been completed.
Secondary outcomes:
measure: Viewing discomfort
timeFrame: Subjective ratings of discomfort were assessed after each condition on the second and third visits, up to 16 days. Data collection and preliminary analysis has been completed.
measure: Visual acuity
timeFrame: Performance was measured in each condition on the second and third visits, up to 16 days. Data collection and preliminary analysis has been completed.
measure: Color perception
timeFrame: Performance was measured in each condition on the second and third visits, up to 16 days. Data collection and preliminary analysis has been completed.
measure: Reading
timeFrame: Performance was measured in each condition on the second and third visits, up to 16 days. Data collection and preliminary analysis has been completed.
measure: Dry eye measurements
timeFrame: Measurement was taken at baseline and after each condition on the second and third visits, up to 16 days. Data collection and preliminary analysis has been completed.
Other outcomes:
Locations:
city: Forest Grove
country: United States
facility: Vision Performance Institute, Pacific University
state: Oregon
Study officials:
affiliation: Pacific University
name: Yu-Chi Tai, PhD
role: PRINCIPAL_INVESTIGATOR
References: