NCT05476068

Brief Summary

To compare the prevalence of dry eye symptoms and to investigate the association of the risk factors with the dry eye symptomatology among university students in the epidemic and non-epidemic areas of China under the COVID-zero strategy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,807

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 23, 2022

Last Update Submit

July 23, 2022

Conditions

Keywords

dry eye symptomsanxietydepression

Outcome Measures

Primary Outcomes (3)

  • A score of ocular surface disease index (OSDI)questionnaire

    Ocular surface disease index (OSDI)questionnaire : (1) OSDI: ≤12 (no DED symptoms), 13 ≤ d ≤ 22 (mild DED symptoms), 23 ≤ d ≤ 32 (moderate DED symptoms), and ≥33 (severe DED symptoms).

    DAY 0

  • A score of GAD-7 questionnaire

    GAD-7 questionnaire: (1) 0 \< GAD-7 ≤ 4 (normal), 5 ≤ GAD-7 ≤ 9 (mild anxiety), 10 ≤ GAD-7 ≤ 13 (moderate anxiety), 14 ≤ GAD-7 ≤ 18 (moderate and severe anxiety), and 19 ≤ GAD-7 ≤ 21 (severe anxiety).

    DAY 0

  • A score of PHQ-9 questionnaire

    PHQ-9 questionnaire: (1) 0 \< PHQ-9 ≤ 4 (normal), 5 ≤ GAD-7 ≤ 9 (mild depression), 10 ≤ GAD-7 ≤ 14 (moderate depression), 15 ≤ GAD-7 ≤ 19 (moderate and severe depression), and 20 ≤ GAD-7 ≤ 27 (severe depression).

    DAY 0

Secondary Outcomes (3)

  • A score of UCLA Loneliness Scale questionnaire

    DAY 0

  • Students' increased use of mobile phones

    DAY 0

  • Frequency of student sports

    DAY 0

Study Arms (2)

Epidemic area (Nanchang, Nanchang university)

Non-epidemic area (Kaifeng, Henan university)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The subjects of the study are students from Nanchang University and Henan University.

You may qualify if:

  • College students with age ≥18 years
  • No other medication history in recent 2 weeks;
  • Have high compliance and are willing to fill in the questionnaire on time

You may not qualify if:

  • routinely using artificial tears and Other eye drops;
  • taking any medication that could interfere with the results of the study;
  • with any history of eye surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University

Study Record Dates

First Submitted

July 23, 2022

First Posted

July 27, 2022

Study Start

March 20, 2022

Primary Completion

May 20, 2022

Study Completion

May 25, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations