NCT05028491

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

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

October 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

August 25, 2021

Last Update Submit

August 31, 2021

Conditions

Meibomian Gland Dysfunction

Keywords

thermal massagecorneal aberrationsphysical therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Officials

  • Yune Zhao

    Ophthalmology and Optometry Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 31, 2021

Study Start

October 1, 2020

Primary Completion

June 29, 2021

Study Completion

July 29, 2021

Last Updated

September 8, 2021

Record last verified: 2021-08

Locations

CN(1)