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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
Scientific title
Effect of intense pulsed light technology in treating Meibomian Gland Dysfunction (MGD)
Secondary ID [1] 284031 0
none
Universal Trial Number (UTN)
U1111-1152-9932
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meibomian Gland Dysfunction 291080 0
Condition category
Condition code
Eye 291425 291425 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288721 0
Treatment: Devices
Comparator / control treatment
Placebo control in paired eye study (treatment performed with IPL blocking filter)
Control group
Placebo

Outcomes
Primary outcome [1] 291411 0
Tear film quality: Lipid layer thickness grading and noninvasive tear film stability measurements by interferometry with the Keeler Tearscope Plus (Trademark)
Timepoint [1] 291411 0
Assessments occur on Days 1, Day 15 and Day 45 before and approximately 10 minutes after treatment administration
Secondary outcome [1] 306714 0
Ocular surface quality: grading of the extent and confluence of sodium fluorescein staining of the cornea and conjunctiva on the Oxford scale.
Timepoint [1] 306714 0
Assessments occur on Days 1, Day 15 and Day 45 before and approximately 10 minutes after treatment administration
Secondary outcome [2] 306715 0
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.
Timepoint [2] 306715 0
Assessments occur on Days 1, Day 15 and Day 45 before and approximately 10 minutes after treatment administration

Eligibility
Key inclusion criteria
Dry eye symptoms (OSDI) and clinical evidence of Meibomian gland dysfunction by meibography
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other anterior segment pathology
Any conditions which preclude treatment by IPL

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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)
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Paired eye comparison, i.e. participant's non-treated eye serves as control.
Phase
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5802 0
New Zealand
State/province [1] 5802 0

Funding & Sponsors
Funding source category [1] 288658 0
Charities/Societies/Foundations
Name [1] 288658 0
New Zealand Association of Optometrists
Address [1] 288658 0
Level 11, 49 Boulcott Street, Wellington 6011, NZ
Country [1] 288658 0
New Zealand
Funding source category [2] 288659 0
Commercial sector/Industry
Name [2] 288659 0
France Medical Pty Ltd
Address [2] 288659 0
1/161 Robertson Street
Fortitude Valley, QLD, 4006
Country [2] 288659 0
Australia
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 287369 0
Commercial sector/Industry
Name [1] 287369 0
France Medical Pty Ltd
Address [1] 287369 0
1/161 Robertson Street
Fortitude Valley, QLD, 4006
Country [1] 287369 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290510 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 290510 0
The University of Auckland
Private Bag 92019
Auckland 1142
Ethics committee country [1] 290510 0
New Zealand
Date submitted for ethics approval [1] 290510 0
Approval date [1] 290510 0
06/12/2013
Ethics approval number [1] 290510 0
UAHPEC 9531

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)
Trial website
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.
Public notes

Contacts
Principal investigator
Name 46022 0
A/Prof Jennifer P Craig
Address 46022 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 46022 0
New Zealand
Phone 46022 0
+6421853664
Fax 46022 0
+6493677173
Email 46022 0
jp.craig@auckland.ac.nz
Contact person for public queries
Name 46023 0
A/Prof Jennifer P Craig
Address 46023 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 46023 0
New Zealand
Phone 46023 0
+6499238173
Fax 46023 0
Email 46023 0
jp.craig@auckland.ac.nz
Contact person for scientific queries
Name 46024 0
A/Prof Jennifer P Craig
Address 46024 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 46024 0
New Zealand
Phone 46024 0
+6499238173
Fax 46024 0
Email 46024 0
jp.craig@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary