Dry Eye Disease (DED)NCT07020871
Correlation of Dry Eye Disease, Problematic Smartphone Use and Sleep Quality in Adolescents and Young Adults
An observational study of Dry Eye Disease (DED), run by Wei XIA, PhD at 1 site in China.
Trial summary
The goal of this observational study is to learn about the status quo and relationship of dry eye, problematic smartphone use, bedtime procrastination, and sleep in adolescents and young adults. Read more about this study
- Who is it for?
- Ages 14 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease (DED)
- How many people
- 453 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: General adolescents and young adults between 14-35 years old
Who may be able to join
- Adolescents and young adults aged 14 to 35 (including 14,25 years old) ;
- Agree to participate in the studies
Who cannot join
- Unable to communicate normally;
- With ocular surface diseases other than dry eye and autoimmune diseases;
- Use drugs that may cause damage to the ocular surface, such as anti glaucoma drugs, antidepressants, sex hormones, chemotherapy drugs, etc.;
- With a history of eye trauma or eye surgery;
- With a history of wearing contact lenses within the past month;
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University
Guangzhou, Guangdong, 510080
Wei Xia PhD, +8618823359471, xiaw23@mail.sysu.edu.cn
About this study
The goal of this observational study is to learn about the status quo and relationship of dry eye, problematic smartphone use, bedtime procrastination, and sleep in adolescents and young adults. The main questions it aims to answer are:
- Is there a positive correlation between problematic smartphone use and dry eye?
- Is problematic smartphone use positively correlated with bedtime procrastination?
- Is bedtime procrastination negatively correlated with sleep quality?
- Is there a negative correlation between sleep quality and dry eye?
- Is there a negative correlation between problematic smartphone use and sleep quality?
- Is there a positive correlation between bedtime procrastination and dry eye?
- Do bedtime procrastination and sleep quality serve as mediating factors in the relationship of problematic smartphone use and dry eye? Participants will be asked to complete several questionnaires and dry eye related examinations.
- Conditions
- Dry Eye Disease (DED)
- Keywords
- dry eye disease, problematic smartphone use, sleep quality, bedtime procrastination, adolescents and young adults
- Medical subject headings
- Dry Eye Syndromes, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Investigation Team | 1. After informed consent, adolescents and young adults aged 14-35 years old (including 14,35 years old) are assessed by questionnaires and dry eye related examinations. 2. The main content is Investigating the relationship among dry eye disease, problematic smartphone use, bedtime procrastination, and sleep quality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry eye symptoms
Ocular Surface Disease Index scale with 12-item will be used to measure dry eye symptoms. The scale uses Likert 5 comments, with a total score ranging from 0 to 100. And the total score reaching or exceeding 13 points indicates that participants exhibit symptoms of dry eye.
Measured: baseline
Problematic smartphone use
The 10-item Smartphone Addiction Scale Short Version will be used to measure the problematic smartphone use. The scale uses Likert 6 comments, with a total score ranging from 10 to 60. And higher scores indicate more severe problematic smartphone use.
Measured: baseline
sleep quality
The Pittsburgh Sleep Quality Index scale is used to measure participants' sleep quality. The total score ranges from 0 to 21. Higher scores indicate lower quality of sleep.
Measured: baseline
bedtime procrastination
There are 9 items in the Bedtime Procrastination Scale, which is used to measure participants' bedtime procrastination. The scale uses 5-point scale, with a total score ranging from 9 to 45. And higher scores indicate more severe procrastination before sleep.
Measured: baseline
Secondary outcomes (2)
Perceived level of stress
The 14-item Chinese Perceived Stress Scale will be used to measure the perceived level of stress among adolescents and young adults. The scale uses Likert 5 comments, with a total score ranging from 0 to 56. And higher scores indicate a greater pressure that individuals feel in their daily lives.
Measured: baseline
non-invasive tear film break-up time
Non-invasive tear film break-up time is measured by Oculus Keratograph 5M. A cut-off value of less than or equal to 10 s has been reported to be indicative of DED.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start20 Jul 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 453 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei XIA, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020871
- Sponsor's protocol ID
- 2024KYPJ090
- Status last verified
- Jul 2025
- First submitted
- 5 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Dry Eye Disease, Problematic Smartphone Use and Sleep Quality in Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT07020871
- Acronym / sponsor ID
- 2024KYPJ090
- Conditions
- Dry Eye Disease (DED)
- Keywords
- dry eye disease, problematic smartphone use, sleep quality, bedtime procrastination, adolescents and young adults
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 453 participants (estimated)
- Lead sponsor
- Wei XIA, PhDUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Jun 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.
The goal of this observational study is to learn about the status quo and relationship of dry eye, problematic smartphone use, bedtime procrastination, and sleep in adolescents and young adults. The main questions it aims to answer are:
- Is there a positive correlation between problematic smartphone use and dry eye?
- Is problematic smartphone use positively correlated with bedtime procrastination?
- Is bedtime procrastination negatively correlated with sleep quality?
- Is there a negative correlation between sleep quality and dry eye?
- Is there a negative correlation between problematic smartphone use and sleep quality?
- Is there a positive correlation between bedtime procrastination and dry eye?
- Do bedtime procrastination and sleep quality serve as mediating factors in the relationship of problematic smartphone use and dry eye? Participants will be asked to complete several questionnaires and dry eye related examinations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigation Team | – | –1. After informed consent, adolescents and young adults aged 14-35 years old (including 14,35 years old) are assessed by questionnaires and dry eye related examinations. 2. The main content is Investigating the relationship among dry eye disease, problematic smartphone use, bedtime procrastination, and sleep quality. |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- General adolescents and young adults between 14-35 years old
Key inclusion criteria (2 listed)
- Adolescents and young adults aged 14 to 35 (including 14,25 years old) ;
- Agree to participate in the studies
Key exclusion criteria (6 listed)
- Unable to communicate normally;
- With ocular surface diseases other than dry eye and autoimmune diseases;
- Use drugs that may cause damage to the ocular surface, such as anti glaucoma drugs, antidepressants, sex hormones, chemotherapy drugs, etc.;
- With a history of eye trauma or eye surgery;
- With a history of wearing contact lenses within the past month;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dry eye symptoms
Time frame: baseline
Ocular Surface Disease Index scale with 12-item will be used to measure dry eye symptoms. The scale uses Likert 5 comments, with a total score ranging from 0 to 100. And the total score reaching or exceeding 13 points indicates that participants exhibit symptoms of dry eye.
Problematic smartphone use
Time frame: baseline
The 10-item Smartphone Addiction Scale Short Version will be used to measure the problematic smartphone use. The scale uses Likert 6 comments, with a total score ranging from 10 to 60. And higher scores indicate more severe problematic smartphone use.
sleep quality
Time frame: baseline
The Pittsburgh Sleep Quality Index scale is used to measure participants' sleep quality. The total score ranges from 0 to 21. Higher scores indicate lower quality of sleep.
bedtime procrastination
Time frame: baseline
There are 9 items in the Bedtime Procrastination Scale, which is used to measure participants' bedtime procrastination. The scale uses 5-point scale, with a total score ranging from 9 to 45. And higher scores indicate more severe procrastination before sleep.
2 secondary outcomes
Perceived level of stress
Time frame: baseline
non-invasive tear film break-up time
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Wei Xia PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease (DED), run by Wei XIA, PhD 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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Jul 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Xia PhD (+8618823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dry eye symptoms (time frame: baseline). The study lists 4 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 10 Jul 2025.