The Influence of Meibomian Gland Expression on Corneal Ab... | NCT05028491

Studies
The Influence of Meibomian Gland Expression on Corneal Aberrations in MGD Patients

NCT05028491

Sponsor

Wenzhou Medical University

Status

Completed

Last Update Posted

Sep 8, 2021Actual

Enrollment

62Actual

Phase

Not provided

Conditions

Meibomian Gland Dysfunction

Interventions

Not provided

Countries

China

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Jun 29, 2021Actual

Completion Date

Jul 29, 2021Actual

First Submitted Date

Aug 25, 2021

First Submission Date that Met QC Criteria

Aug 30, 2021

First Posted Date

Aug 31, 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

Aug 31, 2021

Last Update Posted Date

Sep 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical UniversityPrincipal Investigator

Lead Sponsor

Wenzhou Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 evaluate the influence of corneal-aberrations before and after the meibomian gland thermal massage treatment.

Detailed Description

62 MGD patients treated with meibomian gland thermal massage once a week for 3 to 4 weeks were recruited.The Ocular Surface Disease Index questionnaire; tear film assessment encompassing tear meniscus height and non-invasive keratograph breakup time ; meibography score,corneal fluorescein staining; the Schirmer I test ; expressible meibomian gland, and quality ,anterior and total corneal aberrations were evaluated before and after treatment.

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

62Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
corneal aberration corneal aberrations	Corneal aberrations were measured with a Pentacam。 The anterior corneal wavefront aberration was expanded with normalized Zernike polynomials.The corneal aberration from 3rd to 6th order were recorded as the root mean square (RMS) for analysis.	baseline and 1 week after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

tear break-up time (BUT) ≤10 seconds or Schirmer I test (SIT) ≤10 mm, the presence of dry eye symptoms, and fluorescein staining (FL) score <3 points and at least one lid margin abnormality and poor meibomian gland expressibility

Exclusion Criteria:

eyelid structure abnormal(Entropion , ectropion);
having received any other treatment for MGD within three months
history of ocular surgery
contact lens use
ocular infection
any type of corneal scarring

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Diagnosed as meibomian glands dysfunction in our hospital; treatment with thermal massage and expression

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yune Zhao	Ophthalmology and Optometry Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Hospital of Wenzhou Medical College		Wenzhou	Zhejiang	325027	China

Condition Browse Module

MeSH Terms

ID	Term
D000080343	Meibomian Gland Dysfunction

Ancestor Terms

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided