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Mechanisms of Light-based Therapies for Dry Eye Disease (MOLT)

Primary Purpose

Dry Eye Syndromes, Meibomian Gland Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Actual IPL
Sham IPL
LLLT
Sponsored by
Aston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Intense pulsed light therapy, Low-level light therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals with dry eye disease symptoms (Ocular Surface Disease Index questionnaire (OSDI) score ≥ 13 or Dry Eye Questionnaire (DEQ5) score > 6) and signs (tear film instability measured with non-invasive tear break-up time < 10 s or ocular surface damage measured using special dyes placed on the front surface of the eyes that temporarily stains any aggravated or damaged cells: > 5 corneal spots, > 9 conjunctival spots or lid margin staining ≥ 2mm in length and ≥ 25% in width) (Wolffsohn et al., 2017) Individuals need to also have Meibomian gland dysfunction. The diagnosis of Meibomian gland dysfunction depends on how many of 5 glands in the central lower eyelid can express oil, and the quality of the oil. A diagnosis is made if there is decreased expressibility (grade 1-3 on the Pflugfelder scale) and reduced quality of oil (grade 1-3 on Bron scale). Any presence of gland blockage and/or loss of oil glands grade 2 to grade 4 of either eyelid [Pult and Reide-Pult, 2013]) will also justify a diagnosis of Meibomian gland dysfunction Age ≥ 18 years, male or female Able to provide written consent in English Able to attend multiple visits (4 treatment visits) and followed up for 2 weeks and 3 months after final treatment Exclusion Criteria: Pregnancy Contraindications to IPL treatment (Individuals with darker skin types - Fitzpatrick skin type V or VI, photosensitive epilepsy, tattoos, implants, electrical or acoustic prosthetics, semi-permanent make-up, pigmented lesions or skin cancer in the treatment area, pacemakers, use of photosensitising medication the past 3 months or during treatment period) Facial or ocular IPL or LLLT treatment within the past 6 months or during study period in addition to those provided in the study Use of topical medical eyedrops in the past 3 months or during study period Contact lens wear in the past 2 weeks or during study period Systemic conditions that can cause dry eye disease or corneal nerve loss including diabetes and Sjögren's syndrome Other active ocular surface diseases or history of ocular surgery or corneal infections Individuals with 1 eye

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Actual IPL and LLLT

    Sham IPL and LLLT

    Arm Description

    IPL and LLLT will be administered using the Espansione Group Ltd Eye-light unit. Five pulses of IPL will be administered along the lower lid region of the eye after the Pult meiboscore and Fitzpatrick skin grading has been entered into the unit. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.

    Sham IPL will be administered by placing a separate empty IPL cartridge on the lower eyelid regions of the patient's other eye while a working IPL cartridge (Espansione Group Ltd Eye-light unit) simulates a light pulse pointed away from the patient's face, after entering the Pult meiboscore and Fitzpatrick skin grading into the unit. Five simulated pulses will be administered. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 3 Months After Final Treatment Session
    Measure of the stability of tears and how fast the tears evaporate in seconds using the Oculus Keratograph 5M instrument. An average of 3 measurements is obtained.

    Secondary Outcome Measures

    Change from Baseline in Ocular Surface Disease Index scores to the Final Follow-up 3 Months After Final Treatment Session
    Validated questionnaire for assessing dry eye symptom severity and impact. Scores range from 0 indicating no dry eye symptoms to 100 with severe dry eye symptoms and impact (Schiffman et al, 2000).
    Change from Baseline in 5-Item Dry Eye Questionnaire scores to the Final Follow-up 3 Months After Final Treatment Session
    Validated questionnaire for assessing dry eye symptom severity and frequency. Scores range from 0 indicating no dry eye symptoms to 22 with severe dry eye symptoms (Chalmers et al, 2010).
    Change from Baseline in Tear Meniscus Height to the Final Follow-up 3 Months After Final Treatment Session
    Measure of the volume of tears in mm using the Oculus Keratograph 5M instrument. An average of 3 measurements is obtained.
    Change from Baseline in Lipid Layer Pattern Grading to the Final Follow-up 3 Months After Final Treatment Session
    Subjective grading of the appearance of the lipid layer pattern as a surrogate measure of its thickness using the Oculus Keratograph 5M instrument. This ranges from Grade 1 indicating very thin lipid layer to Grade 6 indicating very thick lipid layer.
    Change from Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 3 Months After Final Treatment Session
    Automated objective grading of the bulbar conjunctival redness using the Oculus Keratograph 5M instrument. This ranges from Grade 0 indicating no redness to Grade 4 indicating substantial redness.
    Change from Baseline in Blink Rate to the Final Follow-up 3 Months After Final Treatment Session
    Manual subjective count of the number of blinks using the Oculus Keratograph 5M instrument.
    Change from Baseline in Visual Acuity to the Final Follow-up 3 Months After Final Treatment Session
    Subjective measure of visual acuity using Logarithm of the Minimum Angle Resolution (logMAR) scoring, ranging from -0.30 which signify the ability to be able to resolve the smallest letters, to 1.00 which signify the ability to resolve only the largest letters.
    Change from Baseline in Fluorescein Corneal Staining to the Final Follow-up 3 Months After Final Treatment Session
    Subjective grading of the amount of corneal staining using fluorescein instillation, cobalt blue light illumination and the Oxford grading scale. This ranges from 0 with no staining to 5 with intense staining.
    Change from Baseline in Lissamine Green Bulbar Conjunctival Staining to the Final Follow-up 3 Months After Final Treatment Session
    Subjective grading of the amount of bulbar conjunctival staining using lissamine green instillation, white light illumination and the Oxford grading scale. This ranges from 0 with no staining to 5 with intense staining.
    Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 3 Months After Final Treatment Session
    Subjective grading of the amount of lid wiper epitheliopathy using lissamine green instillation and white light illumination. This grading ranges from 0 with no lid wiper epitheliopathy to 4 with severe lid wiper epitheliopathy
    Change from Baseline in Meibography Meiboscore to the Final Follow-up 3 Months After Final Treatment Session
    Subjective grading of the amount of Meibomian gland loss using infrared imaging and the Pult meiboscore. This grading ranges from 0 with no gland loss to 4 with severe gland loss (Pult and Reide-Pult, 2013).
    Change from Baseline in Demodex Presence to the Final Follow-up 3 Months After Final Treatment Session
    Subjective assessment of the amount of Demodex present at the base of the lashes using slit lamp biomicroscopy and white light illumination (Muntz et al, 2020).
    Change from Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 3 Months After Final Treatment Session
    Subjective assessment of the number of blocked or capped Meibomian Glands using slit lamp biomicroscopy and white light illumination.
    Change from Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 3 Months After Final Treatment Session
    Subjective grading of the amount of telangiectasia at the lid margins using slit lamp biomicroscopy and white light illumination. This grading ranges from 0 with no telangiectasia to 3 with severe telangiectasia (Arita et al, 2016).
    Change from Baseline in Meibum Expressibility to the Final Follow-up 3 Months After Final Treatment Session
    Subjective grading of meibum expressibility of lower eyelids using slit lamp biomicroscopy and white light illumination. This grading ranges from 0 with all glands being expressible to 3 with no glands being expressible (Tomlinson et al, 2011).
    Change from Baseline in Meibum Quality to the Final Follow-up 3 Months After Final Treatment Session
    Subjective grading of meibum quality of lower eyelids using slit lamp biomicroscopy and white light illumination. This grading ranges from 0 with clear fluid being expressed to 3 with inspissated toothpaste-like expression (Tomlinson et al, 2011).
    Number of Participants with Dry Eye Disease and Meibomian Gland Dysfunction
    The number of participants diagnosed with dry eye disease and Meibomian gland dysfunction according to established clinical diagnostic criteria (Wolffsohn et al, 2017 ; Tomlinson et al, 2011).
    Change from Baseline in Total Corneal Nerve Length to the Final Follow-up 3 Months After Final Treatment Session
    Measure of total corneal nerve length of sub-basal nerve plexi images obtained from in-vivo corneal confocal microscopy.
    Change from Baseline in Blood Flow to the Final Follow-up 3 Months After Final Treatment Session
    Measure of blood flow using laser doppler flowmetry instrument.
    Change from Baseline in Tear Constituent to the Final Follow-up 3 Months After Final Treatment Session
    Measure of tear constituent using Schirmer strip tear sampling technique.

    Full Information

    First Posted
    August 15, 2023
    Last Updated
    August 21, 2023
    Sponsor
    Aston University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06004895
    Brief Title
    Mechanisms of Light-based Therapies for Dry Eye Disease
    Acronym
    MOLT
    Official Title
    Mechanisms of Action of Light-based Therapies in the Management of Dry Eye Disease and Meibomian Gland Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aston University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Dry eye disease is a common condition affecting millions worldwide and costing millions in healthcare due to reduced work productivity and quality of life. The disruption of oil glands in our eyelids known as Meibomian glands, which produce the oily layer of our tears to protect it from evaporating, is one of the most common contributors of dry eye disease. Much effort has been put into developing effective treatments for this condition as new treatments are constantly being introduced to the market. The purpose of this clinical trial is to investigate how proven light-based therapies work in treating dry eye disease and oil gland disruption. These therapies include intense-pulsed light therapy (IPL) which uses a series of light flashes on the facial skin surface, and low-level light therapy (LLLT) which uses a mask with a series of light-emitting diodes (LEDs) to warm the body cells. The main questions it aims to answer are: What are the short- and long-term changes associated with these treatments on the eyelids and surface of the eyes? Does LLLT alone work better than IPL+LLLT in treating dry eye disease and oil gland disruption? Participants with dry eye disease and oil gland disruption will receive four treatments with these light-based therapies each separated by two to three weeks apart, and followed up two to three weeks and three months after the final treatment session. One eye of the participant will receive intense pulsed light together with low-level light therapy, while the other eye will receive only low-level light therapy with a sham intense pulsed light treatment so that the researchers can compare if clinical signs and symptoms improve in one eye more than the other.
    Detailed Description
    This study will be a randomized, double-masked, paired-eye clinical study to assess the potential difference in impact between the two treatment modalities. Each eye of the participant will be randomized to receive either IPL+LLLT or sham IPL+LLLT. The whole study involves a total of 6 visits (consisting of 4 treatment visits, and 2 follow-up visits). All visits will be conducted at the Aston Dry Eye Clinic in Aston University, Birmingham, United Kingdom.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Syndromes, Meibomian Gland Dysfunction
    Keywords
    Intense pulsed light therapy, Low-level light therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    One eye of the participant is randomised to receiving IPL and LLLT, while the other eye of the same participant will receive sham intense pulsed light therapy and low-level light therapy.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Actual IPL and LLLT
    Arm Type
    Experimental
    Arm Description
    IPL and LLLT will be administered using the Espansione Group Ltd Eye-light unit. Five pulses of IPL will be administered along the lower lid region of the eye after the Pult meiboscore and Fitzpatrick skin grading has been entered into the unit. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.
    Arm Title
    Sham IPL and LLLT
    Arm Type
    Sham Comparator
    Arm Description
    Sham IPL will be administered by placing a separate empty IPL cartridge on the lower eyelid regions of the patient's other eye while a working IPL cartridge (Espansione Group Ltd Eye-light unit) simulates a light pulse pointed away from the patient's face, after entering the Pult meiboscore and Fitzpatrick skin grading into the unit. Five simulated pulses will be administered. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.
    Intervention Type
    Device
    Intervention Name(s)
    Actual IPL
    Intervention Description
    Five light pulses along lower lid region of one eye of the participant ranging from 59 to 69 Joules (J) over an area of 2.5cm by 4.5cm for each pulse
    Intervention Type
    Device
    Intervention Name(s)
    Sham IPL
    Intervention Description
    Simulated five light pulses along lower lid region of the other eye of the same participant
    Intervention Type
    Device
    Intervention Name(s)
    LLLT
    Intervention Description
    Mask with LEDs transferring a total of about 32 J/cm^2 of energy to facial and eyelids region with their eyes closed
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Measure of the stability of tears and how fast the tears evaporate in seconds using the Oculus Keratograph 5M instrument. An average of 3 measurements is obtained.
    Time Frame
    Baseline and 3 months after final treatment session
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in Ocular Surface Disease Index scores to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Validated questionnaire for assessing dry eye symptom severity and impact. Scores range from 0 indicating no dry eye symptoms to 100 with severe dry eye symptoms and impact (Schiffman et al, 2000).
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in 5-Item Dry Eye Questionnaire scores to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Validated questionnaire for assessing dry eye symptom severity and frequency. Scores range from 0 indicating no dry eye symptoms to 22 with severe dry eye symptoms (Chalmers et al, 2010).
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Tear Meniscus Height to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Measure of the volume of tears in mm using the Oculus Keratograph 5M instrument. An average of 3 measurements is obtained.
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Lipid Layer Pattern Grading to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Subjective grading of the appearance of the lipid layer pattern as a surrogate measure of its thickness using the Oculus Keratograph 5M instrument. This ranges from Grade 1 indicating very thin lipid layer to Grade 6 indicating very thick lipid layer.
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Automated objective grading of the bulbar conjunctival redness using the Oculus Keratograph 5M instrument. This ranges from Grade 0 indicating no redness to Grade 4 indicating substantial redness.
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Blink Rate to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Manual subjective count of the number of blinks using the Oculus Keratograph 5M instrument.
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Visual Acuity to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Subjective measure of visual acuity using Logarithm of the Minimum Angle Resolution (logMAR) scoring, ranging from -0.30 which signify the ability to be able to resolve the smallest letters, to 1.00 which signify the ability to resolve only the largest letters.
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Fluorescein Corneal Staining to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Subjective grading of the amount of corneal staining using fluorescein instillation, cobalt blue light illumination and the Oxford grading scale. This ranges from 0 with no staining to 5 with intense staining.
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Lissamine Green Bulbar Conjunctival Staining to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Subjective grading of the amount of bulbar conjunctival staining using lissamine green instillation, white light illumination and the Oxford grading scale. This ranges from 0 with no staining to 5 with intense staining.
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Subjective grading of the amount of lid wiper epitheliopathy using lissamine green instillation and white light illumination. This grading ranges from 0 with no lid wiper epitheliopathy to 4 with severe lid wiper epitheliopathy
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Meibography Meiboscore to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Subjective grading of the amount of Meibomian gland loss using infrared imaging and the Pult meiboscore. This grading ranges from 0 with no gland loss to 4 with severe gland loss (Pult and Reide-Pult, 2013).
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Demodex Presence to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Subjective assessment of the amount of Demodex present at the base of the lashes using slit lamp biomicroscopy and white light illumination (Muntz et al, 2020).
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Subjective assessment of the number of blocked or capped Meibomian Glands using slit lamp biomicroscopy and white light illumination.
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Subjective grading of the amount of telangiectasia at the lid margins using slit lamp biomicroscopy and white light illumination. This grading ranges from 0 with no telangiectasia to 3 with severe telangiectasia (Arita et al, 2016).
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Meibum Expressibility to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Subjective grading of meibum expressibility of lower eyelids using slit lamp biomicroscopy and white light illumination. This grading ranges from 0 with all glands being expressible to 3 with no glands being expressible (Tomlinson et al, 2011).
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Meibum Quality to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Subjective grading of meibum quality of lower eyelids using slit lamp biomicroscopy and white light illumination. This grading ranges from 0 with clear fluid being expressed to 3 with inspissated toothpaste-like expression (Tomlinson et al, 2011).
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Number of Participants with Dry Eye Disease and Meibomian Gland Dysfunction
    Description
    The number of participants diagnosed with dry eye disease and Meibomian gland dysfunction according to established clinical diagnostic criteria (Wolffsohn et al, 2017 ; Tomlinson et al, 2011).
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Total Corneal Nerve Length to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Measure of total corneal nerve length of sub-basal nerve plexi images obtained from in-vivo corneal confocal microscopy.
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Blood Flow to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Measure of blood flow using laser doppler flowmetry instrument.
    Time Frame
    Baseline up to 3 months after final treatment session
    Title
    Change from Baseline in Tear Constituent to the Final Follow-up 3 Months After Final Treatment Session
    Description
    Measure of tear constituent using Schirmer strip tear sampling technique.
    Time Frame
    Baseline up to 3 months after final treatment session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Individuals with dry eye disease symptoms (Ocular Surface Disease Index questionnaire (OSDI) score ≥ 13 or Dry Eye Questionnaire (DEQ5) score > 6) and signs (tear film instability measured with non-invasive tear break-up time < 10 s or ocular surface damage measured using special dyes placed on the front surface of the eyes that temporarily stains any aggravated or damaged cells: > 5 corneal spots, > 9 conjunctival spots or lid margin staining ≥ 2mm in length and ≥ 25% in width) (Wolffsohn et al., 2017) Individuals need to also have Meibomian gland dysfunction. The diagnosis of Meibomian gland dysfunction depends on how many of 5 glands in the central lower eyelid can express oil, and the quality of the oil. A diagnosis is made if there is decreased expressibility (grade 1-3 on the Pflugfelder scale) and reduced quality of oil (grade 1-3 on Bron scale). Any presence of gland blockage and/or loss of oil glands grade 2 to grade 4 of either eyelid [Pult and Reide-Pult, 2013]) will also justify a diagnosis of Meibomian gland dysfunction Age ≥ 18 years, male or female Able to provide written consent in English Able to attend multiple visits (4 treatment visits) and followed up for 2 weeks and 3 months after final treatment Exclusion Criteria: Pregnancy Contraindications to IPL treatment (Individuals with darker skin types - Fitzpatrick skin type V or VI, photosensitive epilepsy, tattoos, implants, electrical or acoustic prosthetics, semi-permanent make-up, pigmented lesions or skin cancer in the treatment area, pacemakers, use of photosensitising medication the past 3 months or during treatment period) Facial or ocular IPL or LLLT treatment within the past 6 months or during study period in addition to those provided in the study Use of topical medical eyedrops in the past 3 months or during study period Contact lens wear in the past 2 weeks or during study period Systemic conditions that can cause dry eye disease or corneal nerve loss including diabetes and Sjögren's syndrome Other active ocular surface diseases or history of ocular surgery or corneal infections Individuals with 1 eye
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jeremy Chung Bo Chiang, PhD
    Phone
    +441212043934
    Ext
    3934
    Email
    j.chiang@aston.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James S Wolffsohn, PhD
    Organizational Affiliation
    Aston University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The investigators are planning to deposit deidentified datasets in a publicly and freely available data repository site.
    IPD Sharing Time Frame
    Data will be available at the end of the study before publication of the findings in a peer-reviewed journal.
    IPD Sharing Access Criteria
    The dataset will be publicly and freely available.
    Citations:
    PubMed Identifier
    21450918
    Citation
    Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.
    Results Reference
    background
    PubMed Identifier
    23108007
    Citation
    Pult H, Riede-Pult B. Comparison of subjective grading and objective assessment in meibography. Cont Lens Anterior Eye. 2013 Feb;36(1):22-7. doi: 10.1016/j.clae.2012.10.074. Epub 2012 Oct 27.
    Results Reference
    background
    PubMed Identifier
    28736342
    Citation
    Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. doi: 10.1016/j.jtos.2017.05.001. Epub 2017 Jul 20.
    Results Reference
    background
    PubMed Identifier
    10815152
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20093066
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27345733
    Citation
    Arita R, Minoura I, Morishige N, Shirakawa R, Fukuoka S, Asai K, Goto T, Imanaka T, Nakamura M. Development of Definitive and Reliable Grading Scales for Meibomian Gland Dysfunction. Am J Ophthalmol. 2016 Sep;169:125-137. doi: 10.1016/j.ajo.2016.06.025. Epub 2016 Jun 23.
    Results Reference
    background

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    Mechanisms of Light-based Therapies for Dry Eye Disease

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