NCT04310969

Clinical Effect of MiboFlo in Dry Eye Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Dry Eye Syndromes
• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DEVICE	MiBoFlo Thermoflo	Each treatment for each eye takes 10 minutes and is treated every two weeks for a total of three times. The device was preheated to 42.2℃ and the eyelid was cleaned and smeared with a small amount of ultrasound gel in order to reduce friction between the device and eyelid skin. Then massage the outer skin of the upper and lower eyelids for a period of 10 minutes. The patient's eyes keep closed during therapy.
PROCEDURE	forceful expression of the meibomian glands	Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force
DEVICE	LipiFlow	LipiFlow treatment applies heat to the palpebral surface of eyelids while simultaneously applying graded pulsatile pressure to the outer eyelid surfaces, thereby expressing the meibomian glands during heating.

Timeline

• Start date: 2020-04-03
• Primary completion: 2020-05-15
• Completion: 2020-06-30
• First posted: 2020-03-17
• Last updated: 2020-07-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study