Dry EyeNCT02481167
Evaluation of Meibomian Gland Dysfunction in Chinese Old Patients
An observational study of Dry Eye, run by Wenzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to identify age-related changes in chinese meibomian glands that may be associated with meibomian gland dysfunction (MGD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Dry Eye
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jan 2018
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was consisted of patients with older than 40 years of age who complained with dry eye. The institutional review board of Wenzhou Medical College approved the study protocol, and all patients provided their informed consent.
Who may be able to join
- have dry eye symptom
- have meibomian gland dysfunction
Who cannot join
- diabetes
- history of ocular surgery
- systemic disease or inflammation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenzhou Medical University
Wenzhou, Zhejiang, 325027
XIXIA DING, PHD, 86-057788068859
About this study
The purpose of this study is to identify age-related changes in chinese meibomian glands that may be associated with meibomian gland dysfunction (MGD).
- Conditions
- Dry Eye
- Keywords
- Aged, Meibomian Glands, dry eye, Elderly
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group1 | This study was consisted of patients with older than 40 years of age who complained with dry eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film break-up time
Tear film break-up time (TBUT) was evaluated by placing a single fluorescein strip over the inferior tear meniscus after instilling a drop of normal saline.
Measured: 1 year
Lower tear meniscus
Lower tear meniscus was evaluated by keratography
Measured: 1 year
The morphology of meibomian glands
The morphology of meibomian glands was evaluated by keratography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2016 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yin ying zhao, Wenzhou Medical University
- Investigators
- ZHAO YUNE, MS, Study chair, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481167
- Sponsor's protocol ID
- WZ-ZYY-DRYEYE
- Status last verified
- Jun 2015
- First submitted
- 15 Jun 2015
- Last updated
- 25 Jun 2015
- Results posted
- No
Publications
Li J, Ma J, Hu M, Yu J, Zhao Y. Assessment of tear film lipid layer thickness in patients with Meibomian gland dysfunction at different ages. BMC Ophthalmol. 2020 Oct 6;20(1):394. doi: 10.1186/s12886-020-01667-8.
PubMed 33023522Wu Y, Li J, Hu M, Zhao Y, Lin X, Chen Y, Li L, Zhao YE. Comparison of two intense pulsed light patterns for treating patients with meibomian gland dysfunction. Int Ophthalmol. 2020 Jul;40(7):1695-1705. doi: 10.1007/s10792-020-01337-0. Epub 2020 Mar 21.
PubMed 32200506
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Meibomian Gland Dysfunction in Chinese Old Patients
- ClinicalTrials.gov ID
- NCT02481167
- Acronym / sponsor ID
- WZ-ZYY-DRYEYE
- Conditions
- Dry Eye
- Keywords
- Aged, Meibomian Glands, dry eye, Elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 25 Jun 2015 (estimated)
- 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.
The purpose of this study is to identify age-related changes in chinese meibomian glands that may be associated with meibomian gland dysfunction (MGD).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group1 | – | –This study was consisted of patients with older than 40 years of age who complained with dry eye. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was consisted of patients with older than 40 years of age who complained with dry eye. The institutional review board of Wenzhou Medical College approved the study protocol, and all patients provided their informed consent.
Key inclusion criteria (2 listed)
- have dry eye symptom
- have meibomian gland dysfunction
Key exclusion criteria (3 listed)
- diabetes
- history of ocular surgery
- systemic disease or inflammation
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
Tear film break-up time
Time frame: 1 year
Tear film break-up time (TBUT) was evaluated by placing a single fluorescein strip over the inferior tear meniscus after instilling a drop of normal saline.
Lower tear meniscus
Time frame: 1 year
Lower tear meniscus was evaluated by keratography
The morphology of meibomian glands
Time frame: 1 year
The morphology of meibomian glands was evaluated by keratography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Derived from this study: PubMed 33023522Li J, Ma J, Hu M, Yu J, Zhao Y. Assessment of tear film lipid layer thickness in patients with Meibomian gland dysfunction at different ages. BMC Ophthalmol. 2020 Oct 6;20(1):394. doi: 10.1186/s12886-020-01667-8.
- Derived from this study: PubMed 32200506Wu Y, Li J, Hu M, Zhao Y, Lin X, Chen Y, Li L, Zhao YE. Comparison of two intense pulsed light patterns for treating patients with meibomian gland dysfunction. Int Ophthalmol. 2020 Jul;40(7):1695-1705. doi: 10.1007/s10792-020-01337-0. Epub 2020 Mar 21.
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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.
ZHAO YUNE, MS study chair
Wenzhou Medical University
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 Dry Eye, 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jun 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yinying zhao, PhD (86-057788068859, ginger146@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear film break-up time (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02481167, which also lists 2 linked publications.
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 25 Jun 2015.