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Completed

NCT Number: NCT04310969

Clinical Effect of MiboFlo in Dry Eye Patients

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MiBoFlo Thermoflo

Device

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.

forceful expression of the meibomian glands

Procedure

Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force

LipiFlow

Device

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.

Primary outcomes

  1. subjective symptom score

    Time frame: 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.

  2. Meibomian Glands Yielding Liquid Secretion (MGYLS)

    Time frame: 2 weeks

    The total number of MGYLS was counted for both upper and lower lid of each eye.

  3. Meibomian Glands Secretion (MGS)

    Time frame: 2 weeks

    The total number of MGYLS was counted for both upper and lower lid of each eye.

Secondary outcomes

  1. Corneal Fluorescein Staining(CFS)

    Time frame: 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

  2. Tear Meniscus Height(TMH)

    Time frame: 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.

  3. Non-invasive Keratograph Break-up Time(NIKBUT)

    Time frame: 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.

  4. Meibography

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 17, 2020
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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