Changes in the structure and function of oil-producing glands of the eyelids following Intense Pulsed Light therapy

Not Applicable

• Conditions: Dry eye disease; Meibomian gland dysfunction; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12622001336774
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-18
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in meibomian gland structure using meibography [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 Measures

Name	Time	Method
Change in composition of meibomian gland secretions using lipid analysis [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 ]