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Trial registered on ANZCTR
Registration number
ACTRN12614000162617
Ethics application status
Approved
Date submitted
4/02/2014
Date registered
10/02/2014
Date last updated
4/02/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effect of intense pulsed light (IPL) technology in treating dry eye
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Scientific title
Effect of intense pulsed light technology in treating Meibomian Gland Dysfunction (MGD)
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Secondary ID [1]
284031
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none
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Universal Trial Number (UTN)
U1111-1152-9932
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Meibomian Gland Dysfunction
291080
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Condition category
Condition code
Eye
291425
291425
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
At each visit, IPL is performed using a non-coherent, filtered broadband pulsed flash lamp (E>Eye, France Medical, Brisbane, Australia), at 9 - 13 J/cm^2 (according to skin type), in four pulses per eye (manufacturer's proprietary pulse profile), below the lower eyelid from the outer to inner canthus, while metal light-blocking goggles are worn to protect globe. Treatments are performed on Day 1, Day 15 and Day 45, with treatment duration of approximately 20 seconds.
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Intervention code [1]
288721
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Treatment: Devices
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Comparator / control treatment
Placebo control in paired eye study (treatment performed with IPL blocking filter)
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Control group
Placebo
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Outcomes
Primary outcome [1]
291411
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Tear film quality: Lipid layer thickness grading and noninvasive tear film stability measurements by interferometry with the Keeler Tearscope Plus (Trademark)
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Assessment method [1]
291411
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Timepoint [1]
291411
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Assessments occur on Days 1, Day 15 and Day 45 before and approximately 10 minutes after treatment administration
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Secondary outcome [1]
306714
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Ocular surface quality: grading of the extent and confluence of sodium fluorescein staining of the cornea and conjunctiva on the Oxford scale.
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Assessment method [1]
306714
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Timepoint [1]
306714
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Assessments occur on Days 1, Day 15 and Day 45 before and approximately 10 minutes after treatment administration
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Secondary outcome [2]
306715
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Subjective comfort evaluated by requesting participants mark their level of comfort (of each eye independently) on a 100mm visual analogue scale (VAS) with verbal anchors of extremely comfortable and extremely uncomfortable, at either end.
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Assessment method [2]
306715
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Timepoint [2]
306715
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Assessments occur on Days 1, Day 15 and Day 45 before and approximately 10 minutes after treatment administration
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Eligibility
Key inclusion criteria
Dry eye symptoms (OSDI) and clinical evidence of Meibomian gland dysfunction by meibography
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Other anterior segment pathology
Any conditions which preclude treatment by IPL
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subject must satisfy eligibility criteria
Subjects consecutively assigned right eye or left eye treatment according to computer-generated randomization table
Subject vision obscured by light blocking goggles.
Treatment to one eye, sham treatment (with blocking filter on IPL machine) in control eye
Investigator collecting data and analyzing data is masked as to which eye is treated. (Treatment performed by independent clinical investigator)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization schedule.
Participants enrolled consecutively to pre-determined randomisation schedule by independent investigator
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
Paired eye comparison, i.e. participant's non-treated eye serves as control.
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
To detect a 10% difference in outcome measures between the treated and untreated eyes, for 80% power at a confidence level of 95%, the sample size was calculated as 23 participants. Up to 30 participants will be recruited to compensate for any drop-out.
Paired comparison (t-test/ANOVA and Wilcoxan/ Kruskal-Wallis) will be performed to detect device effect, while repeated measures AVOVA/Friedmann will allow determination of time effect for normally and non-normally distributed data, respectively.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
6/01/2014
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Date of last participant enrolment
Anticipated
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Actual
7/02/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
28
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Recruitment outside Australia
Country [1]
5802
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New Zealand
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State/province [1]
5802
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Funding & Sponsors
Funding source category [1]
288658
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Charities/Societies/Foundations
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Name [1]
288658
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New Zealand Association of Optometrists
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Address [1]
288658
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Level 11, 49 Boulcott Street, Wellington 6011, NZ
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Country [1]
288658
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New Zealand
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Funding source category [2]
288659
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Commercial sector/Industry
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Name [2]
288659
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France Medical Pty Ltd
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Address [2]
288659
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1/161 Robertson Street
Fortitude Valley, QLD, 4006
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Country [2]
288659
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Australia
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Primary sponsor type
University
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Name
The University of Auckland
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Address
Private Bag 92019
Auckland 1142
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Country
New Zealand
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Secondary sponsor category [1]
287369
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Commercial sector/Industry
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Name [1]
287369
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France Medical Pty Ltd
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Address [1]
287369
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1/161 Robertson Street
Fortitude Valley, QLD, 4006
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Country [1]
287369
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
290510
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University of Auckland Human Participants Ethics Committee
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Ethics committee address [1]
290510
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The University of Auckland Private Bag 92019 Auckland 1142
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Ethics committee country [1]
290510
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New Zealand
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Date submitted for ethics approval [1]
290510
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Approval date [1]
290510
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06/12/2013
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Ethics approval number [1]
290510
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UAHPEC 9531
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Summary
Brief summary
To identify changes to the tear film and ocular surface in participants with meibomian gland dysfunction, in response to 3 treatments (on Days 1, 15 and 45) with intense pulsed light (E>Eye, France Medical Ltd Pty, Aust)
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Trial website
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Trial related presentations / publications
Craig JP, Chen YH, Turnbull PR. Prospective trial of intense pulsed light for the treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2015 Feb 12;56(3):1965-70.
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Public notes
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Contacts
Principal investigator
Name
46022
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A/Prof Jennifer P Craig
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Address
46022
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Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
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Country
46022
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New Zealand
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Phone
46022
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+6421853664
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Fax
46022
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+6493677173
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Email
46022
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jp.craig@auckland.ac.nz
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Contact person for public queries
Name
46023
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Jennifer P Craig
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Address
46023
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Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
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Country
46023
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New Zealand
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Phone
46023
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+6499238173
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Fax
46023
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Email
46023
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jp.craig@auckland.ac.nz
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Contact person for scientific queries
Name
46024
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Jennifer P Craig
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Address
46024
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Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
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Country
46024
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New Zealand
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Phone
46024
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+6499238173
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Fax
46024
0
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Email
46024
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jp.craig@auckland.ac.nz
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Prospective trial of intense pulsed light for the treatment of meibomian gland dysfunction.
2015
https://dx.doi.org/10.1167/iovs.14-15764
N.B. These documents automatically identified may not have been verified by the study sponsor.
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