Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction

Dry Eye Clinical Trial

Official title:

Prospective Study of the Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04425551
• Other study ID #: 6/19
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: February 2021

Study information

• Verified date: June 2020
• Source: Naval Hospital, Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The modern treatment of meibomian gland dysfunction(MGD) is based on anti-inflammatory drops or oral antibiotics for decreasing dry eye disease (DED) associated inflammation, warm compresses for liquefying the thicker meibum, and lid hygiene for reducing the bacterial overload. But, such treatments have shown limited effectiveness to a large proportion of patients with MGD, due to the multifactorial background of the disease. Thus, alternative approaches aiming at different aspects of the DED pathophysiology are needed.

Elimination of posterior lid-margin hyperemia with telangiectasia could be a treatment target for reducing the secretion of inflammatory mediators in the course of MGD. Using the mechanism of photocoagulation via selective thermolysis, laser light could contribute to the destruction of abnormal vessels at the posterior lid-margin and thus, the reduction of inflammation. Recently, sub-threshold (micropulse) laser photocoagulation was introduced in ophthalmology and offers significant clinical advantages compared to conventional continuous wave (CW) approach, preventing laser induced thermal damage and related treatment side effects.

This study investigates the effect of sub-threshold (micropulse) laser treatment for dry eye disease due to meibomian gland dysfunction combined with increased eyelid margin vascularity.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: February 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18-80 years

• chief complaint of more than one of dryness, foreign-body sensation, burning, and tearing for 3 months

• diagnosis of MGD with palpebral telangiectasia in both eyes

Exclusion Criteria:

• ocular structural abnormalities

• history of ocular trauma or surgery

• use of any treatment for DE or MGD, other than artificial tears, within the past month

• active allergy, infection, or inflammatory disease at the ocular surface unrelated to DE or MGD

• lacrimal drainage-system anomalies

• contact-lens wear

• use of any systemic anti-inflammatory medicine

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Procedure:
• laser light
laser light destruction of telangiectatic vessels of lower eyelid margin via selective thermolysis

Locations

Country	Name	City	State
Greece	Naval Hospital of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Naval Hospital, Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Lower Eyelid Margin Vascularity	Lower Eyelid Margin Vascularity is measured with ImageJ® software for vessels analysis from photographs of lower eyelid margin. Vascularity is evaluated as percentage (%) of lower eyelid margin surface. Time points are referred at ''Time Frame'' section.	Baseline, Day 0 after treatment, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
Secondary	Ocular Surface Disease Index (OSDI)	scale (0-100). Higher values represent greater disability.	Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
Secondary	Tear Break Up Time (TBUT)	time (seconds). Higher values represent greater disability.	Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
Secondary	Lower Eyelid Tear Meniscus Height	height (µm)	Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
Secondary	Meibomography	scale (0,1,2,3). Higher values represent greater disability.	Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment