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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Shuping Li Master
  • Phone Number: +8618826073426
  • Email: lishpy@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline
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.
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
baseline
non-invasive tear film break-up time
Time Frame: baseline
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
baseline
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).
baseline
Lipid layer thickness (LLT) and blinking pattern
Time Frame: baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wei XIA, PhD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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