Clinical Effect of MiboFlo in Dry Eye Patients

Capital Medical University

Status: Completed

Conditions: Meibomian Gland Dysfunction; Dry Eye Syndromes

Treatments: Device: MiBoFlo Thermoflo; Procedure: forceful expression of the meibomian glands; Device: LipiFlow

Study type: Interventional

Funder types: Other

Identifiers

NCT04310969

TRECKY2019-099

Details and patient eligibility

About

The aim of this prospective study is to compare the changes between the patients receiving traditional treatment and the patients with MiBoFlo, evaluating the effectiveness of MiBoFlo.

Full description

The MiBoFlo Thermoflo uses a proprietary thermoelectric heat pump to help meibum maximize liquefaction, improving the preservation and function of the tear film's evaporative component. It supplies continuous controlled heat to the outer skin of the eyelids, absorbing deep into the tissue and breaks down the hardened oils in the meibomian glands. We are trying to find a effective, safe and economical therapy for dry eye patients.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age of older;
• Meet the diagnostic criteria for dry eye developed by DEWS II: OSDI score≥15 points, TBUT≤10 minutes;
• Meet the signs of meibomian gland dysfunction

Exclusion criteria

• Had skin allergies or inflammation;
• Had active ocular infection or inflammation;
• Had history of ocular surgery, eyelid surgery or neurological paralysis within 6 months;
• Had history of systemic disease affecting ocular surface function, such as Stevens-Johnson syndrome, Sjögren syndrome etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

treatment group

Experimental group

Description:

Patients are treated every two weeks for a total of three times. Forceful expression of the meibomian glands is followed after each therapy.

Treatment:

Device: MiBoFlo Thermoflo

Procedure: forceful expression of the meibomian glands

control group

Sham Comparator group

Description:

Forceful expression of the meibomian glands only for patients.

Treatment:

Procedure: forceful expression of the meibomian glands

active control group

Active Comparator group

Description:

LipiFlow® treatment is used as an active comparator.

Treatment:

Device: LipiFlow