Clinical Effect of MiboFlo in Dry Eye Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Effect of MiboFlo in Dry Eye Patients

Conditions
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Dry Eye Syndromes, Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: MiBoFlo Thermoflo
* Procedure: forceful expression of the meibomian glands
* Device: LipiFlow


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Patients are treated every two weeks for a total of three times. Forceful expression of the meibomian glands is followed after each therapy. | Device: MiBoFlo Thermoflo<br>* 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.<br>Procedure: forceful expression of the meibomian glands<br>* Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force<br>|
| Sham Comparator: control group<br>Forceful expression of the meibomian glands only for patients. | Procedure: forceful expression of the meibomian glands<br>* Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force<br>|
| Active Comparator: active control group<br>LipiFlow® treatment is used as an active comparator. | Device: LipiFlow<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective symptom score | 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. | 2 weeks | 
| Meibomian Glands Yielding Liquid Secretion (MGYLS) | The total number of MGYLS was counted for both upper and lower lid of each eye. | 2 weeks | 
| Meibomian Glands Secretion (MGS) | The total number of MGYLS was counted for both upper and lower lid of each eye. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Fluorescein Staining(CFS) | 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 | 2 weeks | 
| Tear Meniscus Height(TMH) | 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. | 2 weeks | 
| Non-invasive Keratograph Break-up Time(NIKBUT) | The NIKBUT was used to evaluate tear film stability and assessed by Oculus Keratograph 5M. The average NIKBUT was recorded into the statistical result. | 2 weeks | 
| Meibography | 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 | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, meibomian gland dysfunction, therapy