Mask-associated Dry Eye Symptoms in China | NCT04744805

Studies
Mask-associated Dry Eye Symptoms in China

NCT04744805

Sponsor

Tianjin Eye Hospital

Status

Unknown status

Last Update Posted

Feb 9, 2021Actual

Enrollment

6,262Estimated

Phase

Not provided

Conditions

Dry Eye Syndromes

Interventions

face mask or not

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 29, 2021Estimated

Primary Completion Date

Feb 5, 2021Estimated

Completion Date

Feb 6, 2021Estimated

First Submitted Date

Feb 4, 2021

First Submission Date that Met QC Criteria

Feb 4, 2021

First Posted Date

Feb 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2021

Last Update Posted Date

Feb 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To review the relationship of increased face mask usage arising from lockdown measures instituted during the COVID-19 pandemic with dry eye symptoms on Chinese people, and make recommendations for mitigating potential detrimental effects on dry eye symptoms.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6,262Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mask wear			Other: face mask or not
dry eye			Other: face mask or not

Interventions

Name	Type	Description	Arm Group Labels	Other Names
face mask or not	Other	long term face mask wear	dry eye mask wear

Measure	Description	Time Frame
time of face mask wear		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >=8 years mental health

Exclusion Criteria:

eye diseases mental or systemic diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

An online survey of persons focused on face mask usage

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yan Wang, director	Contact	+862227313336		wangyan7143@vip.sina.com

Overall Officials

Name	Affiliation	Role
Yan Wang, director	Tianjin Eye Hospital	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35418586	Derived	Fan Q, Liang M, Kong W, Zhang W, Wang H, Chu J, Fang X, Song Y, Gao W, Wang Y. Wearing face masks and possibility for dry eye during the COVID-19 pandemic. Sci Rep. 2022 Apr 13;12(1):6214. doi: 10.1038/s41598-022-07724-0.

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

ID	Term
D008397	Masks
D057126	Nuclear Receptor Subfamily 4, Group A, Member 2

ID	Term
D058257	Surgical Attire
D004865	Equipment and Supplies, Hospital
D004864	Equipment and Supplies
D011482	Protective Devices