Dry Eye Clinical Trial
Official title:
The Effect of Computer Eyewear on Viewing Comfort and Performance in Office Work
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).
<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.
;
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05102409 -
An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease
|
Phase 2 | |
Completed |
NCT05027087 -
The Effect of a Novel Blueberry Supplement on Dry Eye Disease
|
Phase 3 | |
Completed |
NCT06159569 -
Performance and Tolerability of the Medical Device LACRIACT
|
N/A | |
Completed |
NCT04081610 -
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
|
Phase 1 | |
Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
Completed |
NCT05825599 -
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
|
N/A | |
Completed |
NCT03418727 -
Dry Eye Disease Study With Brimonidine
|
Phase 2 | |
Active, not recruiting |
NCT04425551 -
Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
|
N/A | |
Recruiting |
NCT04527887 -
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
|
Phase 4 | |
Not yet recruiting |
NCT06379685 -
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.
|
Phase 1 | |
Active, not recruiting |
NCT05618730 -
Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B
|
Phase 1 | |
Completed |
NCT04553432 -
Dry Eye OmniLenz Application of Omnigen Research Study
|
Phase 4 | |
Recruiting |
NCT04109170 -
Dry Eye Evaluation System Based on Bioinformatics
|
||
Completed |
NCT04105842 -
Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
|
N/A | |
Completed |
NCT05505292 -
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT04668131 -
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
|
N/A | |
Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT02235259 -
Efficacy and Safety of XG-104 for the Treatment of Dry Eye
|
Phase 2 | |
Not yet recruiting |
NCT02218827 -
Topical Steroid Treatment For Dry Eye
|
N/A | |
Completed |
NCT01959854 -
Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye
|
N/A |