Dry Eye Disease (DED)NCT06992635
Effect of Smart Phone Reflective Light Film on Dry Eyes and Asthenopia
A study testing using non-processing screens and using AR+CP screens in people with Dry Eye Disease (DED) and Asthenopia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aimed to evaluate the effect of anti-reflection (AR) and circularly polarized (CP) film on video display terminal (VDT) induced dry eye and asthenopia after limited time and close distance of visual tasks under light and dark environment, searching for new strategy for eye-protective electronic screen. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease (DED), Asthenopia
- What is being tested?
- using non-processing screens and using AR+CP screens
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.have basic reading comprehension skills and to be older than 18 years old. 2.diopter of both eyes not exceeding -6.0D and anisometropia not exceeding 2.0D.
Who cannot join
- presbyopia or decreased regulation function, ocular inflammation and disease, worn contact lens within 1 month, history of eye surgery within 6 months, lactating or pregnant woman, have severe systemic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
Hangzhou, Zhejiang, 310000
About this study
This study aimed to evaluate the effect of anti-reflection (AR) and circularly polarized (CP) film on video display terminal (VDT) induced dry eye and asthenopia after limited time and close distance of visual tasks under light and dark environment, searching for new strategy for eye-protective electronic screen. The study was randomized, double-blind and controlled. Subjects were enrolled following the criteria: diopter of both eyes not exceeding -6.0D and anisometropia not exceeding 2.0D. and randomly divided into control, AR, AR+CP group in light or dark environment. Character searching, gaming and video tasks utilizing specific smartphones for totally 45 minutes were performed. Researchers measured the indexes of dry eye and asthenopia before and after tasks to evaluate impacts induced by VDT.
Read the detailed description
The inclusion criteria required volunteers to have myopia diopter not exceeding -6.00D, hyperopia not exceeding +2.0D, astigmatism not exceeding -2.00D, anisometropia between both eyes not exceeding 2.00D. The key exclusion criteria were as follows: (1)strabismus and amblyopia; (2)used eye drops within 1 week; (3)had undergone eye surgery within 6 months; (4)worn contact lenses within the last 2 weeks; (5)had serious eye discomfort in the last 7 days; (6)Breastfeeding or pregnant women and patients with severe systemic diseases, psychosis or dementia.
Subjects who met the criteria were divided into five groups. 3 groups using non-processing smartphone screen, anti-reflection screen and anti-reflection plus circular polarization screen read in light environment and 2 groups using non-processing screen and anti-reflection plus circular polarization screen read in dark environment. Subjects did not know the characteristics of the smartphones they use. Subjects met the requirements were randomly grouped. The subjects did not use video terminals such as mobile phones within 30 minutes before the study began.
During the whole experiment, light-group subjects were in a room with normal indoor ceiling light, correlated colour temperature 3904K, desktop illuminance 388.7lux, screen brightness about 150nit, while dark-group in environment illuminance 0.02lux, screen brightness about 6nit. Light source stability (working surface illuminance fluctuation) greater than 99% during the whole experiment, desktop range uniformity greater than 80%. Desktop matte treatment without special reflection, indoor air conditioning control temperature: 22-25 degrees Celsius, humidity: 50-70%RH. Users placed it on a fixed mobile phone stand (the angle and height of the mobile phone stand can be adjusted to make sure all subjects could see reflection of the lamp on ceiling behind them from the smartphone black screen state). All subjects' eyes are 40cm away from the mobile phone screen, and they sit on a chair of appropriate height and fixed position. Two groups of subjects would complete the following three tasks in definite order: 1) Character searching task (5 minutes) : Subject read a meaningless text on the screen, found all the target characters in it, and told researchers about the statistics; 2) Game task: Subject played one of several pre-installed games requiring high concentration and eye tracking for 20 minutes; 3) Video task: Subject watched the video Animal World with the mobile phone for 20 minutes. During the study period, subjects should not do any behavior unrelated to watching the screen for a long time (more than 1 minute). We evaluated the subjects' basic ocular data: best corrected visual acuity(BCVA), spherical equivalent(SE), subjective questionnaires including Ocular Surface Disease Index(OSDI), Computer Vision Syndrome Scale 17 (CVSS17); dry eye comprehensive analysis before and after the experiment respectively: tear meniscus height(TMH), noninvasive tear break-up time(NIBUT), fluorescein tear break-up time(FBUT), corneal fluorescein staining(CFS), Schirmer I tear secretion test; asthenopia related examination: High-frequency component(HFC) and blink frequency.
- Conditions
- Dry Eye Disease (DED), Asthenopia
- Being tested
- using non-processing screens, using AR+CP screens
- Medical subject headings
- Dry Eye Syndromes, Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using non-processing screensBehavioural
ask subjects to use non-processing screens
using AR+CP screensBehavioural
ask subjects to use AR+CP screens
| Study group | Role | What they receive |
|---|---|---|
| light condition | Sham comparator | use smartphone under light condition for 45 minutes Receives: Behavioral: using non-processing screens; Behavioral: using AR+CP screens |
| dark condition | Experimental | use smartphone under dark condition for 45 minutes Receives: Behavioral: using non-processing screens; Behavioral: using AR+CP screens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flourescence tear break-up time
Drop a drop of physiological saline onto a sodium fluorescein test strip. Gently touch the middle of the conjunctiva of both lower eyelids of the examinee with the test strip respectively, and instruct the examinee to blink their eyes gently and look straight ahead. The examiner observed the tear film of the examinee with cobalt blue light under a slit lamp. The time of tear film rupture was the time from the examinee opening their eyes to the appearance of the first black spot on the tear film. Three TBUT tests were detected and recorded for each eye respectively, and the average and maximum values were taken.
Measured: 2 months
HFC (high frequency component of accommodative fluctuation)
The SCR mode of the ACOMOREF K-MODEL computerized optometer was adopted. The subjects were asked to keep a close eye on the image. The image distance was gradually moved from infinity to 1m, 60cm, and 30cm, and remained at each of the four distances for 20 seconds. The equipment would analyze and record the high-frequency fluctuations of the subjects' ciliary muscles, known as HFC. After the test of the first eye, Take a 20-second break to test the second eye.
Measured: 2 months
non-invasive tear break-up time
The Oculus ocular surface comprehensive analyzer was adopted. The examinees sat upright in front of the instrument and were asked to blink their eyes lightly and then look at the red marked object. The instrument automatically conducted ocular surface image analysis to obtain and record the first NIBUT and average NIBUT of the examinees
Measured: 2 months
Secondary outcomes (4)
tear meniscus height
The Oculus ocular surface comprehensive analyzer was used. The person being examined sat upright in front of the instrument and was asked to blink their eyes slightly and then look at the red marked object. The instrument automatically analyzed the ocular surface images to obtain the lacrimal river height data
Measured: 2 months
corneal fluorescein staining
After character searching, gaming and video tasks utilizing specific smartphones for totally 45 minutes, CFS was measured.
Measured: 2 months
computer vision symptom scale 17
A subjective scale reflecting the symptoms of visual fatigue, including the occurrence frequency and intensity of 17 ocular and extraocular symptoms
Measured: 2 months
Schirmer I test
The subjects were tested under non-anesthetic conditions. A 5mm×35mm filter paper was placed in the conjunctival sac of the inner 1/3 of the lower eyelid, with the remaining part hanging over the skin surface. The subjects were asked to gently close their eyes. After 5 minutes, the length of the filter paper soaked by tears was measured and recorded.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Jun 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992635
- Sponsor's protocol ID
- 2024-0631
- Status last verified
- May 2024
- First submitted
- 8 May 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smart Phone Reflective Light Film on Dry Eyes and Asthenopia
- ClinicalTrials.gov ID
- NCT06992635
- Acronym / sponsor ID
- 2024-0631
- Conditions
- Dry Eye Disease (DED), Asthenopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the effect of anti-reflection (AR) and circularly polarized (CP) film on video display terminal (VDT) induced dry eye and asthenopia after limited time and close distance of visual tasks under light and dark environment, searching for new strategy for eye-protective electronic screen. The study was randomized, double-blind and controlled. Subjects were enrolled following the criteria: diopter of both eyes not exceeding -6.0D and anisometropia not exceeding 2.0D. and randomly divided into control, AR, AR+CP group in light or dark environment. Character searching, gaming and video tasks utilizing specific smartphones for totally 45 minutes were performed. Researchers measured the indexes of dry eye and asthenopia before and after tasks to evaluate impacts induced by VDT.
Detailed description
The inclusion criteria required volunteers to have myopia diopter not exceeding -6.00D, hyperopia not exceeding +2.0D, astigmatism not exceeding -2.00D, anisometropia between both eyes not exceeding 2.00D. The key exclusion criteria were as follows: (1)strabismus and amblyopia; (2)used eye drops within 1 week; (3)had undergone eye surgery within 6 months; (4)worn contact lenses within the last 2 weeks; (5)had serious eye discomfort in the last 7 days; (6)Breastfeeding or pregnant women and patients with severe systemic diseases, psychosis or dementia.
Subjects who met the criteria were divided into five groups. 3 groups using non-processing smartphone screen, anti-reflection screen and anti-reflection plus circular polarization screen read in light environment and 2 groups using non-processing screen and anti-reflection plus circular polarization screen read in dark environment. Subjects did not know the characteristics of the smartphones they use. Subjects met the requirements were randomly grouped. The subjects did not use video terminals such as mobile phones within 30 minutes before the study began.
During the whole experiment, light-group subjects were in a room with normal indoor ceiling light, correlated colour temperature 3904K, desktop illuminance 388.7lux, screen brightness about 150nit, while dark-group in environment illuminance 0.02lux, screen brightness about 6nit. Light source stability (working surface illuminance fluctuation) greater than 99% during the whole experiment, desktop range uniformity greater than 80%. Desktop matte treatment without special reflection, indoor air conditioning control temperature: 22-25 degrees Celsius, humidity: 50-70%RH. Users placed it on a fixed mobile phone stand (the angle and height of the mobile phone stand can be adjusted to make sure all subjects could see reflection of the lamp on ceiling behind them from the smartphone black screen state). All subjects' eyes are 40cm away from the mobile phone screen, and they sit on a chair of appropriate height and fixed position. Two groups of subjects would complete the following three tasks in definite order: 1) Character searching task (5 minutes) : Subject read a meaningless text on the screen, found all the target characters in it, and told researchers about the statistics; 2) Game task: Subject played one of several pre-installed games requiring high concentration and eye tracking for 20 minutes; 3) Video task: Subject watched the video Animal World with the mobile phone for 20 minutes. During the study period, subjects should not do any behavior unrelated to watching the screen for a long time (more than 1 minute). We evaluated the subjects' basic ocular data: best corrected visual acuity(BCVA), spherical equivalent(SE), subjective questionnaires including Ocular Surface Disease Index(OSDI), Computer Vision Syndrome Scale 17 (CVSS17); dry eye comprehensive analysis before and after the experiment respectively: tear meniscus height(TMH), noninvasive tear break-up time(NIBUT), fluorescein tear break-up time(FBUT), corneal fluorescein staining(CFS), Schirmer I tear secretion test; asthenopia related examination: High-frequency component(HFC) and blink frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| light condition | Sham comparator | Behavioral: using non-processing screens, Behavioral: using AR+CP screensuse smartphone under light condition for 45 minutes |
| dark condition | Experimental | Behavioral: using non-processing screens, Behavioral: using AR+CP screensuse smartphone under dark condition for 45 minutes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1.have basic reading comprehension skills and to be older than 18 years old. 2.diopter of both eyes not exceeding -6.0D and anisometropia not exceeding 2.0D.
Key exclusion criteria (1 listed)
- presbyopia or decreased regulation function, ocular inflammation and disease, worn contact lens within 1 month, history of eye surgery within 6 months, lactating or pregnant woman, have severe systemic diseases.
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 |
|---|---|---|
| using non-processing screensask subjects to use non-processing screens | Behavioural | dark condition, light condition |
| using AR+CP screensask subjects to use AR+CP screens | Behavioural | dark condition, light condition |
Primary outcome
Flourescence tear break-up time
Time frame: 2 months
Drop a drop of physiological saline onto a sodium fluorescein test strip. Gently touch the middle of the conjunctiva of both lower eyelids of the examinee with the test strip respectively, and instruct the examinee to blink their eyes gently and look straight ahead. The examiner observed the tear film of the examinee with cobalt blue light under a slit lamp. The time of tear film rupture was the time from the examinee opening their eyes to the appearance of the first black spot on the tear film. Three TBUT tests were detected and recorded for each eye respectively, and the average and maximum values were taken.
HFC (high frequency component of accommodative fluctuation)
Time frame: 2 months
The SCR mode of the ACOMOREF K-MODEL computerized optometer was adopted. The subjects were asked to keep a close eye on the image. The image distance was gradually moved from infinity to 1m, 60cm, and 30cm, and remained at each of the four distances for 20 seconds. The equipment would analyze and record the high-frequency fluctuations of the subjects' ciliary muscles, known as HFC. After the test of the first eye, Take a 20-second break to test the second eye.
non-invasive tear break-up time
Time frame: 2 months
The Oculus ocular surface comprehensive analyzer was adopted. The examinees sat upright in front of the instrument and were asked to blink their eyes lightly and then look at the red marked object. The instrument automatically conducted ocular surface image analysis to obtain and record the first NIBUT and average NIBUT of the examinees
4 secondary outcomes
tear meniscus height
Time frame: 2 months
corneal fluorescein staining
Time frame: 2 months
computer vision symptom scale 17
Time frame: 2 months
Schirmer I test
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using non-processing screens and using AR+CP screens in people with Dry Eye Disease (DED) and Asthenopia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 1 inclusion and 1 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Flourescence tear break-up time (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.