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Evaluation of the effectiveness of LipiFlow in the treatment of MGD

Evaluation of the effectiveness of LipiFlow in the treatment of MGD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013856
Enrollment
Unknown
Registered
2017-12-12
Start date
2016-05-01
Completion date
Unknown
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

meibomian gland dysfunction

Interventions

1:LipiFlow
2:Hot compress

Sponsors

Beijing Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and more, male or female; 2. Strictly implement the informed consent process of the subject, the subject's consent must be read, signed and dated by the subject, host or designated person; 3. Subjective dry eye symptoms using the SPEED questionnaire, each eye symptoms score 6 points or higher; 4. Both eyes were meibomian gland dysfunction. Fifteen glands of the lower eyelid, meiyal gland lipid secretion score (MGYLS) of 12 or less (range, 0-45) were evaluated for each eye; 5. Cooperate with the test testing process, if assigned to the control group, abide to do hot compress treatment at home; 6. To be able to complete all visits and follow-ups.

Exclusion criteria

Exclusion criteria: 1. SPEED score of 15 or above; 2. More than 50% glandular defects of lower eyelid meibomian glands are found in the meibomian gland photography; 3. Concomitant ocular diseases that can result in increased therapeutic damage, such as ocular infection or inflammation in any one eye; ocular surgery or trauma within the first trimester of baseline examinations; and the abnormality of ocular surface affecting corneal integrity of any one eye; eyelid abnormalities affecting eyelid function in either eye; 4. Dry eye caused by systemic disease and unwillingness to abandon systemic drug therapy that leads to dry eye during the study; 5.The punctum puncture placement or lacrimal ductoplasty within three months before baseline examination. If a subject with a punctum plug or tear tube angioplasty was performed three months earlier, a new punctal plug was not allowed to be placed or lacrimal ductoplasty during the study; 6. Participate in other ophthalmic clinical trials involving the treatment of medications or medical devices within 30 days prior to baseline examinations.

Design outcomes

Primary

MeasureTime frame
Patient's symptoms (SPEED and OSDI questionnaire);tear break-up time (TBUT);Meibomian gland opening evaluation (MGE);Lipid layer thickness (LLT);

Secondary

MeasureTime frame
Evaluation of meibomian glandular photography;Fluorescein staining in cornea and conjunctiva;Incomplete blink frequency (PB);Corneal Sensitivity;

Countries

China

Contacts

Public ContactWang Ningli

Beijing Tongren Hospital, Capital Medical University

wningli@vip.163.com+86 13511026669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026