Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001336774p
Ethics application status
Submitted, not yet approved
Date submitted
30/09/2022
Date registered
18/10/2022
Date last updated
18/10/2022
Date data sharing statement initially provided
18/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in the structure and function of oil-producing glands of the eyelids following Intense Pulsed Light therapy
Scientific title
Changes in meibomian gland structure and function in adults suffering from dry eye disease following Intense Pulsed Light Therapy
Secondary ID [1] 308057 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye disease 327758 0
Meibomian gland dysfunction 327759 0
Condition category
Condition code
Eye 324829 324829 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intense pulsed light (IPL) therapy is a commercially available procedure that is being used for treating dry eyes. There will be altogether four sessions, two-weeks apart for a two-months time period. Total duration of the IPL sessions including adjustments of parameters is approximately 30 minutes. Based on randomisation, each participant will receive 30 pulses of IPL therapy on each eye at each visit around the peri-ocular area i.e. around the eye involving cheeks and forehead. A fully trained, qualified optometrists will administer the intervention.To adjust the treatment parameters to a specific participant, the investigator will determine the skin type before treatment, ensure that the appropriate filter is inserted in this system, and adjust the IPL settings according to the skin type and the condition to treat according to manufacturer’s instructions. Before the treatment begins, both eyes will be protected with goggles or disposable eye patches, and a thin layer of transparent gel spread on the treatment area which includes the cheeks, the nose, and the skin below the lower eyelids. The IPL energy will be delivered with a handpiece held by the investigator. Before the actual treatment, the investigator will perform a “test spot” to assess the skin reaction to a single IPL pulse applied in an inconspicuous area of the face.
Following each IPL session, meibomian glands will be expressed using meibomian gland expressing forceps. As intervention is conducted in-office, there will be no monitoring of adherence required. Researchers will be able to monitor adherence based on participants attendance to the study visits.
Intervention code [1] 324514 0
Treatment: Devices
Comparator / control treatment
Participants allocated to the placebo group will receive a sham treatment, and participant masking will be achieved by following the same pre-treatment procedures as for the IPL therapy group, but a device with a non-illuminating handpiece will be applied to the periocular area in the same manner as the treatment group, while an active handpiece will be directed away from the participant towards the corner of the room to imitate the illumination and sounds of the IPL device in order to simulate the treatment.
Following each sham treatment, meibomian glands will be expressed using meibomian gland expressing forceps. There will be altogether four sessions, two-weeks apart for a two-months time period. Total duration of the sham sessions including adjustments of parameters is approximately 30 minutes. A fully trained, qualified optometrists will administer the intervention.As sham intervention is also conducted in-office, there will be no monitoring of adherence required. Researchers will be able to monitor adherence based on participants attendance to the study visits.
Control group
Placebo

Outcomes
Primary outcome [1] 332644 0
Change in meibomian gland structure using meibography
Timepoint [1] 332644 0
Assessed prior to and immediately after each IPL treatment (Visits 1-4), and at Visit 5 (Day 56) i.e. 2 weeks after receiving the fourth and final IPL treatment
Secondary outcome [1] 414216 0
Change in composition of meibomian gland secretions using lipid analysis
Timepoint [1] 414216 0
Assessed prior to and immediately after each IPL treatment (Visits 1-4), and at Visit 5 (Day 56) i.e. 2 weeks after receiving the fourth and final IPL treatment

Eligibility
Key inclusion criteria
1. Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent
2. Aged 18 years or over
3. Minimum of 6 months since the onset of self-reported dry eye
4. Have dry eye symptoms: Ocular Surface Disease Index score (OSDI) of >12 and Contact lens dry eye questionnaire (CLDEQ-8 greater than or equal to 12) (for contact lens users only) and evidence of MG obstruction i.e. meibomian gland secretion score greater Ethan or equal to 12
5. May or may not use soft contact lenses
6. All prescription medications have been used consistently for at least 3 months prior to the study, and no planned changes for the duration of the trial
7. Willing to comply with the study visit schedule and adhere to instructions as directed by the Investigator
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any active anterior segment disease
2. Any eyelid abnormality including lid lacerations
3. Patients who are currently using topical ocular medication or have used topical ocular medication within 12 weeks of the first visit
4. Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, and systemic lupus erythematosus;
5. Gas permeable contact lens wearer (including ortho-k) within 6 months of the first visit
6. Anyone who has received clinical skin treatments within the prior 2 months, or implants beneath the treatment area including tattoos, semi-permanent makeup, or pigmented lesions
7. Dark pigmented skin tone according to Fitzpatrick scale V/VI (very dark or black skin), which is prone to skin damage, such as discoloration or scarring after IPL treatment (according to the manufacturer’s guidelines)
8. Skin cancer, the user of photosensitive drugs /foods
9. Anyone who has previously received IPL therapy for dry eye treatment
10. Pregnancy or breastfeeding.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample of 34 participants (17 in each group) will have 95% power at the 5% level of significance to detect a group difference of 120.22 µm units using the mean diameter of glands. This sample size was calculated on the basis of detecting a difference in gland structure where the expected standard deviation of the measurement is approx. 20.30 µm.
Data analysis will be performed using SPSS 22.0(SPSS Inc., Chicago, IL). Clinical markers will be classified as parametric or nonparametric after testing for normality using the Shapiro- Wilk test. Data will be summarised as means± standard deviations for variables measured on an interval scale and median± inter-quartile range for ordinal variables. At each visit, pre-and post-IPL variables will be compared. Repeated measures analysis will allow comparison at various time points and paired analyses will allow comparison of pre-and post-IPL data at individual time points. Multifactorial analysis of variance will be compared the mean/median differences of variables with each of the two treatments between baseline and follow-up visits. The p value is set at p<0.05. Bonferroni adjustment will be used for multiple comparisons

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2022
Actual
Date of last participant enrolment
Anticipated
15/03/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23232 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 38601 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 312314 0
University
Name [1] 312314 0
University of New South Wales
Country [1] 312314 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales, Kensington campus, 2052 NSW.
Country
Australia
Secondary sponsor category [1] 313867 0
None
Name [1] 313867 0
Address [1] 313867 0
Country [1] 313867 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311682 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 311682 0
The University of New South Wales Research Ethics Committee.
UNSW, Gate 14, Kensington 2052 NSW.
Ethics committee country [1] 311682 0
Australia
Date submitted for ethics approval [1] 311682 0
04/10/2022
Approval date [1] 311682 0
Ethics approval number [1] 311682 0

Summary
Brief summary
Meibomian Glands (MGs) in the eyelids play a significant role in tear production by contributing lipids (oils) to the superficial tear film. Meibomian Gland Dysfunction (MGD) affects up to 70% of the population and is a multifactorial disease characterised by abnormal MG structure with characteristic changes in the quality or quantity of MG secretions (meibum). Meibum secretions play a crucial role in ocular surface health. Lipids secreted by MGs have an essential role in reducing the evaporation of the tears from the ocular surface. However, while treatments such as Intense Pulsed Light (IPL) therapy have been shown to improve ocular symptoms and signs including dryness, grittiness and burning sensations , any associated changes in gland structure and function are not known. Therefore, it is important to understand the effect of such treatments on the morphology (structure) of these glands and the composition of meibum secretions to better understand the disease process.
This project aims to evaluate the changes in meibomian gland structure and function in a symptomatic dry eye population with evidence of MGD, following intense pulsed light therapy.
The research question/hypothesis that this study seeks to address is:
Whether there is any measurable change in the structure and function of meibomian glands following IPL therapy?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121978 0
Dr Jacqueline Tan-Showyin
Address 121978 0
School of Optometry & Vision Science
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Australia
Country 121978 0
Australia
Phone 121978 0
+61 02 9385 6551
Fax 121978 0
Email 121978 0
Jacqueline.tan@unsw.edu.au
Contact person for public queries
Name 121979 0
Ms Fatima Iqbal
Address 121979 0
School of Optometry & Vision Science
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Australia
Country 121979 0
Australia
Phone 121979 0
+61450899684
Fax 121979 0
Email 121979 0
fatima.iqbal@unsw.edu.au
Contact person for scientific queries
Name 121980 0
Ms Fatima Iqbal
Address 121980 0
School of Optometry & Vision Science
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Australia
Country 121980 0
Australia
Phone 121980 0
+61 450898684
Fax 121980 0
Email 121980 0
fatima.iqbal@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.