NCT04608942

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 20, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

September 20, 2020

Last Update Submit

October 24, 2020

Conditions

Meibomian Gland DysfunctionDry Eye DiseaseEvaporative Dry EyeInflammationTear Film Deficiency

Keywords

meibomian gland dysfunction (MGD)evaporative dry eye disease (E-DED)jett plasma medical lift

Outcome Measures

Primary Outcomes (7)

  • Dry Eye Questionnaire (DEQ-5)

    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).

    30 days

  • Ocular Surface Disease Index (OSDI)

    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).

    30 days

  • Bulbar redness

    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.

    30 days

  • Tear film meniscus height

    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.

    30 days

  • Non-invasive tear breakup time (NITBUT)

    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.

    30 days

  • Tear film osmolarity

    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).

    30 days

  • Meibomian gland expression

    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?).

    30 days

Secondary Outcomes (7)

  • Dry Eye Questionnaire (DEQ-5)

    90 days

  • Ocular Surface Disease Index (OSDI)

    90 days

  • Bulbar redness

    90 days

  • Tear film meniscus height

    90 days

  • Non-invasive tear breakup time (NITBUT)

    90 days

  • +2 more secondary outcomes

Study Arms (2)

Jett Plasma Medical Lift Application

EXPERIMENTAL

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

Mechanical Debridement

ACTIVE COMPARATOR

In the control group, the mechanical debridement of the superior and inferior eyelid margin with a scalpel blade will be performed.

Procedure: Mechanical Debridement

Interventions

Jett Plasma Medical LiftDEVICE

Plasma Application versus Mechanical Debridement in refractory meibomian gland dysfunction

Jett Plasma Medical Lift Application
Mechanical DebridementPROCEDURE

Plasma Application versus Mechanical Debridement in refractory meibomian gland dysfunction

Mechanical Debridement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[Nelson 1930\];

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Departamento de Oftalmologia da Escola Paulista de Medicina - UNIFESP

São Paulo, São Paulo, 04023 062, Brazil

Location

Department of Ophthalmology, UNIFESP&EPM

São Paulo, São Paulo, Brazil

Location

Related Publications (15)

  • Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.

    PMID: 28736335BACKGROUND

  • Nichols KK, Foulks GN, Bron AJ, Glasgow BJ, Dogru M, Tsubota K, Lemp MA, Sullivan DA. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1922-9. doi: 10.1167/iovs.10-6997a. No abstract available.

    PMID: 21450913BACKGROUND

  • 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.

    BACKGROUND

  • Stapleton F, Alves M, Bunya VY, Jalbert I, Lekhanont K, Malet F, Na KS, Schaumberg D, Uchino M, Vehof J, Viso E, Vitale S, Jones L. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017 Jul;15(3):334-365. doi: 10.1016/j.jtos.2017.05.003. Epub 2017 Jul 20.

    PMID: 28736337BACKGROUND

  • Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.

    PMID: 10815152BACKGROUND

  • Chalmers RL, Begley CG, Caffery B. Validation of the 5-Item Dry Eye Questionnaire (DEQ-5): Discrimination across self-assessed severity and aqueous tear deficient dry eye diagnoses. Cont Lens Anterior Eye. 2010 Apr;33(2):55-60. doi: 10.1016/j.clae.2009.12.010. Epub 2010 Jan 25.

    PMID: 20093066BACKGROUND

  • Tian L, Qu JH, Zhang XY, Sun XG. Repeatability and Reproducibility of Noninvasive Keratograph 5M Measurements in Patients with Dry Eye Disease. J Ophthalmol. 2016;2016:8013621. doi: 10.1155/2016/8013621. Epub 2016 Apr 12.

    PMID: 27190639BACKGROUND

  • Olson MC, Korb DR, Greiner JV. Increase in tear film lipid layer thickness following treatment with warm compresses in patients with meibomian gland dysfunction. Eye Contact Lens. 2003 Apr;29(2):96-9. doi: 10.1097/01.ICL.0000060998.20142.8D.

    PMID: 12695712BACKGROUND

  • Dougherty JM, McCulley JP, Silvany RE, Meyer DR. The role of tetracycline in chronic blepharitis. Inhibition of lipase production in staphylococci. Invest Ophthalmol Vis Sci. 1991 Oct;32(11):2970-5.

    PMID: 1917401BACKGROUND

  • Korb DR, Blackie CA. Restoration of meibomian gland functionality with novel thermodynamic treatment device-a case report. Cornea. 2010 Aug;29(8):930-3. doi: 10.1097/ICO.0b013e3181ca36d6.

    PMID: 20531168BACKGROUND

  • Korb DR, Blackie CA. Debridement-scaling: a new procedure that increases Meibomian gland function and reduces dry eye symptoms. Cornea. 2013 Dec;32(12):1554-7. doi: 10.1097/ICO.0b013e3182a73843.

    PMID: 24145633BACKGROUND

  • Arita R, Mizoguchi T, Fukuoka S, Morishige N. Multicenter Study of Intense Pulsed Light Therapy for Patients With Refractory Meibomian Gland Dysfunction. Cornea. 2019 Feb;38(2):e4. doi: 10.1097/ICO.0000000000001779. No abstract available.

    PMID: 30418276BACKGROUND

  • 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.

    BACKGROUND

  • Vanden Bosch ME, Wall M. Visual acuity scored by the letter-by-letter or probit methods has lower retest variability than the line assignment method. Eye (Lond). 1997;11 ( Pt 3):411-7. doi: 10.1038/eye.1997.87.

    PMID: 9373488BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Meibomian Gland DysfunctionDry Eye SyndromesInflammation

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesLacrimal Apparatus DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rossen M Hazarbassanov, MD PhD

    Associate Professor in Ophthalmology (Federal University of Sao Paulo - UNIFESP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Ophthalmology

Study Record Dates

First Submitted

September 20, 2020

First Posted

October 30, 2020

Study Start

November 11, 2019

Primary Completion

August 7, 2020

Study Completion

August 31, 2022

Last Updated

October 30, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)