None listed
Conditions
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?
Interventions
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
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.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed