- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07020871
- Original Trial
Correlation of Dry Eye Disease, Problematic Smartphone Use and Sleep Quality in Adolescents and Young Adults
July 5, 2025 updated by: Wei XIA, PhD
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
453
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wei Xia PHD
- Phone Number: +8618823359471
- Email: xiaw23@mail.sysu.edu.cn
Study Contact Backup
- Name: Shuping Li Master
- Phone Number: +8618826073426
- Email: lishpy@163.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Sun Yat-sen University
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Contact:
- Wei Xia PHD
- Phone Number: +8618823359471
- Email: xiaw23@mail.sysu.edu.cn
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
General adolescents and young adults between 14-35 years old
Description
Inclusion Criteria:
- Adolescents and young adults aged 14 to 35 (including 14,25 years old) ;
- Agree to participate in the studies
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Investigation Team
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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baseline
|
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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.
|
baseline
|
|
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.
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baseline
|
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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.
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived level of stress
Time Frame: baseline
|
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.
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baseline
|
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non-invasive tear film break-up time
Time Frame: baseline
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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.
|
baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tear meniscus height
Time Frame: baseline
|
The Ocular Keratograph 5M was utilized to measure the tear meniscus height directly beneath three points: the center of the pupil, the nasal corneal limbus, and the temporal corneal limbus.
The average of these three measurements was calculated to serve as the final data for tear meniscus height.
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baseline
|
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Meibomian gland loss
Time Frame: baseline
|
The degree of Meibomian gland loss was scored according to the meiboscore (Grade 0: no dropout, Grade 1: dropout of 2/3 of lid area, Grade 2: dropout of 1/3-2/3 of lid area, Grade 3: dropout of >2/3 of lid area).
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baseline
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Lipid layer thickness (LLT) and blinking pattern
Time Frame: baseline
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The LLT and blinking pattern were assessed using LipiView interferometer.
The LLT information included the minimum, maximum, and average for 20 seconds.
The blinking pattern was obtained by determining the total blinking and partial blinking rates in 20 seconds and then calculating the partial blinking/total blinking ratio.
|
baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wei Xia PHD, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 20, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
June 5, 2025
First Submitted That Met QC Criteria
June 5, 2025
First Posted (Actual)
June 13, 2025
Study Record Updates
Last Update Posted (Actual)
July 10, 2025
Last Update Submitted That Met QC Criteria
July 5, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024KYPJ090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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