Meibomian Gland DysfunctionNCT05028491
The Influence of Meibomian Gland Expression on Corneal Aberrations in MGD Patients
An observational study of Meibomian Gland Dysfunction, run by Wenzhou Medical University at 1 site in China.
Trial summary
To evaluate the influence of corneal-aberrations before and after the meibomian gland thermal massage treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Meibomian Gland Dysfunction
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 29 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed as meibomian glands dysfunction in our hospital; treatment with thermal massage and expression
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Meibomian Gland Thermal Massage on Corneal Aberrations in Meibomian Gland Dysfunction Patients
To evaluate the influence of corneal-aberrations before and after the meibomian gland thermal massage treatment.
Read the 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.
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- thermal massage, corneal aberrations, physical therapy
- Medical subject headings
- Meibomian Gland Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start1 Oct 2020
- Primary completion29 Jun 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
- Investigators
- Yune Zhao, Study director, Ophthalmology and Optometry Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028491
- Sponsor's protocol ID
- hf-meibomian glands
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Meibomian Gland Thermal Massage on Corneal Aberrations in Meibomian Gland Dysfunction Patients
- ClinicalTrials.gov ID
- NCT05028491
- Acronym / sponsor ID
- hf-meibomian glands
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- thermal massage, corneal aberrations, physical therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed as meibomian glands dysfunction in our hospital; treatment with thermal massage and expression
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- eyelid structure abnormal(Entropion , ectropion);
- having received any other treatment for MGD within three months
- history of ocular surgery
- contact lens use
- ocular infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
corneal aberration corneal aberrations
Time frame: baseline and 1 week after treatment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yune Zhao study director
Ophthalmology and Optometry Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meibomian Gland Dysfunction, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal aberration corneal aberrations (time frame: baseline and 1 week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.