Clinical Effect of MiboFlo in Dry Eye Patients

Not Applicable

Completed

• Conditions: Dry Eye Syndromes; Meibomian Gland Dysfunction
• Interventions: Device: MiBoFlo Thermoflo; Device: LipiFlow; Procedure: forceful expression of the meibomian glands

• Registration Number: NCT04310969
• Lead Sponsor: Beijing Tongren Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-15
• Study First Posted: 2020-03-17
• Study Start: 2020-04-03
• Primary Completion: 2020-05-15
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	forceful expression of the meibomian glands	Patients are treated every two weeks for a total of three times. Forceful expression of the meibomian glands is followed after each therapy.
treatment group	MiBoFlo Thermoflo	Patients are treated every two weeks for a total of three times. Forceful expression of the meibomian glands is followed after each therapy.
active control group	LipiFlow	LipiFlow® treatment is used as an active comparator.
control group	forceful expression of the meibomian glands	Forceful expression of the meibomian glands only for patients.

Primary Outcome Measures

Name	Time	Method
subjective symptom score	2 weeks	Ocular Surface Disease Index (OSDI©) questionnaire was chosen to assess subjective symptoms of dry eye, which can demonstrate sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
Meibomian Glands Yielding Liquid Secretion (MGYLS)	2 weeks	The total number of MGYLS was counted for both upper and lower lid of each eye.
Meibomian Glands Secretion (MGS)	2 weeks	The total number of MGYLS was counted for both upper and lower lid of each eye.

Secondary Outcome Measures

Name	Time	Method
Tear Meniscus Height(TMH)	2 weeks	The lower eyelid tear meniscus was photographed under a white light source by Oculus Keratograph 5M, and TMH was measured with the built-in ruler in order to estimate tear secretion.
Non-invasive Keratograph Break-up Time(NIKBUT)	2 weeks	The NIKBUT was used to evaluate tear film stability and assessed by Oculus Keratograph 5M. The average NIKBUT was recorded into the statistical result.
Meibography	2 weeks	Meibography was performed using Meibo-Scan attached to the Oculus Keratograph 5M. Structural changes of meibomian were observed with infrared light source. Partial or complete loss of the meibomian glands was scored using the following grading system: grade 0 indicated no loss of meibomian glands, grade 1 indicated lost area less than one third of the total area of meibomian glands, grade 2 indicated lost area between one third and two thirds of total area, grade 3 indicated lost area more than two thirds of the total area
Corneal Fluorescein Staining(CFS)	2 weeks	Fluorescein was applied in the lower conjunctival sac of each eye with a fluorescein sodium ophthalmic strip (Jingming New Technological Development Co., Ltd, Tianjin, China), and corneal erosion assessed by CFS was scored using the following grading system: grade 0 indicated no corneal erosion, grade 1 indicated 1-5 punctate epithelial erosions seen inferiorly, grade 2 indicated 6-30 punctate epithelial erosions, grade 3 indicated more than 30 punctate epithelial erosions

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China