Clinical trial NCT04425551: Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
Official title: Prospective Study of the Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Dry Eye Syndromes
Meibomian Gland Dysfunction
Keywords: dry eye
meibomian gland dysfunction
laser
Lead sponsor: Naval Hospital, Athens
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant's clinically worse eye was selected for treatment, while the other eye was observed as control. If both eyes were clinically same, one of them was randomly selected.

\*Please note that there was one group of participants, but two groups of eyes (treated/untreated). Thus, PARALLEL was selected, referring to eyes, not participants
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Lower Eyelid Margin Vascularity
timeFrame: Baseline, Day 0 after treatment, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
Secondary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
measure: Tear Break Up Time (TBUT)
timeFrame: Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
measure: Lower Eyelid Tear Meniscus Height
timeFrame: Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
measure: Meibomography
timeFrame: Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Naval Hospital of Athens
Study officials:
affiliation: Naval Hospital, Athens
name: Nikolaos Kappos, MD
role: PRINCIPAL_INVESTIGATOR
References: