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Refractory Meibomian Gland Dysfunction and Plasma Jet

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ClinicalTrials.gov Identifier: NCT04608942
Recruitment Status : Active, not recruiting
First Posted : October 30, 2020
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Rossen Mihaylov Hazarbassanov, MD, PhD, Federal University of São Paulo

Brief Summary:

PURPOSE: The investigators propose a new treatment for refractory Meibomian Gland Dysfunction (MGD) patients with plasma jet to remove the hyperkeratinization layer from the lid margin to unblock terminal gland ducts and use thermal stimulation to enhance meibum delivery.

METHODS: A prospective, interventional clinical safety and efficacy trial with 25 patients from the Department of Ophthalmology at Escola Paulista de Medicina (UNIFESP) to determine the efficacy and safety of the treatment of refractory MGD patients with plasma jet on both upper and lower lids. Patients will be submitted to an ophthalmology workup with best-corrected visual acuity (BCVA) (ETDRS chart) and dry eye questionnaires (DEQ-5 and OSDI). Bulbar redness, tear film meniscus height, noninvasive breakup time (NIKBUT), meibography under infrared light will be measured with Keratograph (Oculus®). Following, tear film osmolarity (i-PenTM), meibomian gland expression, and Marx line assessment. All exams were performed at the baseline, 30 days, and 90 days after the plasma jet application.


Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Dry Eye Disease Evaporative Dry Eye Inflammation Tear Film Deficiency Device: Jett Plasma Medical Lift Procedure: Mechanical Debridement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Plasma Jet Approach for Refractory Meibomian Gland Dysfunction Patients
Actual Study Start Date : November 11, 2019
Actual Primary Completion Date : August 7, 2020
Estimated Study Completion Date : August 31, 2022

Arm Intervention/treatment
Experimental: Jett Plasma Medical Lift Application
In the study group, the plasma jet will be applied to the superior and inferior eyelid margin in both eyes.
Device: Jett Plasma Medical Lift
Plasma Application versus Mechanical Debridement in refractory meibomian gland dysfunction

Active Comparator: Mechanical Debridement
In the control group, the mechanical debridement of the superior and inferior eyelid margin with a scalpel blade will be performed.
Procedure: Mechanical Debridement
Plasma Application versus Mechanical Debridement in refractory meibomian gland dysfunction




Primary Outcome Measures :
  1. Dry Eye Questionnaire (DEQ-5) [ Time Frame: 30 days ]
    Dry Eye Questionnaire (DEQ-5) comprises of 5 quick questions and its score ranges from 0 to 22, with lower scores indicating a less severe disease (improvement).

  2. Ocular Surface Disease Index (OSDI) [ Time Frame: 30 days ]
    Ocular Surface Disease Index (OSDI) comprises of 12 questions, each one scored from 0 to 4, and the final score, on a scale from 0 to 100, result from the sum of all values divided by the number of questions answered. Lower scores indicate a less severe disease (improvement).

  3. Bulbar redness [ Time Frame: 30 days ]
    Conjunctival hyperemia will be measured with Keratograph (Oculus®, Inc). This software grades de hyperemia in both nasal and temporal bulbar regions and in the limbal area, with a final score indicating overall ocular surface redness. Greater scores indicate greater hyperemia.

  4. Tear film meniscus height [ Time Frame: 30 days ]
    Tear film meniscus height will be measured with Keratograph (Oculus®, Inc). This software allows individual measurente of the tear film meniscus height (in milimeters) that will be performed in three regions (nasal, central and temporal tear meniscus) and the arithmetic average will be considered to evaluate treatment outcomes, with increased heights indicanting more tear volume.

  5. Non-invasive tear breakup time (NITBUT) [ Time Frame: 30 days ]
    Non-invasive tear breakup time (NITBUT) will be assessed first with Keratograph (Oculus®, Inc). The NITBUT evaluate the tear film stability by registering the time lapse for the first rupture in the tear film to appear. Greater values indicates a more stable tear film.

  6. Tear film osmolarity [ Time Frame: 30 days ]
    Tear film osmolarity will be measured by collecting a micro drop from the tear meniscus with i-Pen (i-Med Pharma, Inc). The tear osmolarity is used to indirect assess occular surface inflammation, with tear osmolalities greater than 308 mOsm or a difference between eyes greater than 8 mOsm indicating tear film disturbance (Dry Eye WorkShop II - DEWS II 2017).

  7. Meibomian gland expression [ Time Frame: 30 days ]
    Meibomian gland expression will be performed using Meibomian Gland Evaluator (MGE), a special devide with precise pression, that will allow to assess meibomian glands in the slit lamp. This devices acts on five glands at a time, so meibum deliverance can be judged in quantity (is there any gland duct obstructed?) and quality (is meibum clear, cloudy or opaque?).


Secondary Outcome Measures :
  1. Dry Eye Questionnaire (DEQ-5) [ Time Frame: 90 days ]
    Dry Eye Questionnaire (DEQ-5) comprises of 5 quick questions and its score ranges from 0 to 22, with lower scores indicating a less severe disease (improvement).

  2. Ocular Surface Disease Index (OSDI) [ Time Frame: 90 days ]
    Ocular Surface Disease Index (OSDI) comprises of 12 questions, each one scored from 0 to 4, and the final score, on a scale from 0 to 100, result from the sum of all values divided by the number of questions answered. Lower scores indicate a less severe disease (improvement).

  3. Bulbar redness [ Time Frame: 90 days ]
    Conjunctival hyperemia will be measured with Keratograph (Oculus®, Inc). This software grades de hyperemia in both nasal and temporal bulbar regions and in the limbal area, with a final score indicating overall ocular surface redness. Greater scores indicate greater hyperemia.

  4. Tear film meniscus height [ Time Frame: 90 days ]
    Tear film meniscus height will be measured with Keratograph (Oculus®, Inc). This software allows individual measurente of the tear film meniscus height (in milimeters) that will be performed in three regions (nasal, central and temporal tear meniscus) and the arithmetic average will be considered to evaluate treatment outcomes, with increased heights indicanting more tear volume.

  5. Non-invasive tear breakup time (NITBUT) [ Time Frame: 90 days ]
    Non-invasive tear breakup time (NITBUT) will be assessed first with Keratograph (Oculus®, Inc) and then with florescein dye. The NITBUT evaluate the tear film stability by registering the time lapse for the first rupture in the tear film to appear. Greater values indicates a more stable tear film.

  6. Tear film osmolarity [ Time Frame: 90 days ]
    Tear film osmolarity will be measured by collecting a micro drop from the tear meniscus with i-Pen (i-Med Pharma, Inc). The tear osmolarity is used to indirect assess occular surface inflammation, with tear osmolalities greater than 308 mOsm or a difference between eyes greater than 8 mOsm indicating tear film disturbance (Dry Eye WorkShop II - DEWS II 2017).

  7. Meibomian gland expression [ Time Frame: 90 days ]
    Meibomian gland expression will be performed using Meibomian Gland Evaluator (MGE), a special devide with precise pression, that will allow to assess meibomian glands in the slit lamp. This devices acts on five glands at a time, so meibum deliverance can be judged in quantity (is there any gland duct obstructed?) and quality (is meibum clear, cloudy or opaque?).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Refractory meibomian gland dysfunction;
  • Previous eyelid hygiene with warm compress in the last 6 months;
  • Previous oral intake of antibiotics and antiinflammatories in the last 6 months;
  • Previous oral tetracycline treatment for at least one month in the last 6 months;
  • DEQ-5 score greater than 6;
  • OSDI score greater than 13;
  • Tear film osmolarity greater than 308mOsm or a difference between eyes greater than 8 mOsm;
  • Meibomian gland expression greater than 8;
  • Meibomian gland expression grades 2 or 3 [Nelson 1930];

Exclusion Criteria:

  • Cardiac pacemaker or ECG Holter;
  • Other electromagnetic device implanted;
  • Epilepsy;
  • Pregnancy;
  • Metal implants in the periocular area;
  • Skin diseases in the periocular area;
  • Systemic inflammatory diseases;
  • Oncological diseases;
  • Allergy to local anesthetics;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608942


Locations
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Brazil
Departamento de Oftalmologia da Escola Paulista de Medicina - UNIFESP
Sao Paulo, SP, Brazil, 04023 062
Department of Ophthalmology, UNIFESP&EPM
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Rossen M Hazarbassanov, MD PhD Associate Professor in Ophthalmology (Federal University of Sao Paulo - UNIFESP)
Publications:
Scott E Schachter, Aubrey Schachter, Milton M Hom, Scott G Hauswirth; Prevalence of MGD, blepharitis, and demodex in an optometric practice.. Invest. Ophthalmol. Vis. Sci. 2014;55(13):49.
Tremblay JF, Moy R. Treatment of post-auricular skin using a novel plasma resurfacing system: an in vivo clinical and histologic study (abstract). Lasers Surg Med. 2004;34 (suppl 16):25.
Marx E. Uber vitale farbungen am auge und an den lidern. I. Uber anatomie, physiologie und pathologie des Aagenlidrandes und der tranenpunkte. Graefes Arch Clin Exp Ophthalmol. 1924;114:465-82.

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Responsible Party: Rossen Mihaylov Hazarbassanov, MD, PhD, Associate Professor in Ophthalmology, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT04608942    
Other Study ID Numbers: 31031420.6.0000.5505
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rossen Mihaylov Hazarbassanov, MD, PhD, Federal University of São Paulo:
meibomian gland dysfunction (MGD)
evaporative dry eye disease (E-DED)
jett plasma medical lift
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Meibomian Gland Dysfunction
Inflammation
Pathologic Processes
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Eyelid Diseases