Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD

ConditionsDry Eye Syndromes Meibomian Gland Dysfunction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe University of Hong Kong

About this trial

The goal of this prospective, 24-week, double-masked, randomized, sham-controlled clinical trials to compare clinical efficacy and safety of RF and MGX with MGX alone in patients with meibomian gland dysfunction-related dry eye disease. The main question it aims to answer is whether radiofrequency treatment and meibomian gland expression is more effective in improving tear breakup time, as measured using non-invasive video keratography, compared with meibomian gland expression alone, in patients with refractory meibomian gland dysfunction-related dry eye disease.

Participants will be divided into two groups, one group will receive RF treatment followed with MGX and another will receive sham treatment with MGX.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or more

Bilateral dry eye disease as confirmed by presence of both symptoms and signs 2.1 Symptoms: Abnormal result on the Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) dry eye symptom questionnaire (≥5) 2.2 Signs: Abnormal result in at least one of the following three clinical tests - tear osmolarity, NIKBUT and corneal staining for punctate epithelial erosions and,

Bilateral moderate to severe meibomian gland dysfunction - at least Grade 1 meibum quality (cloudy appearance) and Grade 2 meibum expressibility (moderate pressure required). And,

Refractory MGD - The failure to respond to at least three types of conventional therapy, including artificial tears, topical or systemic antibiotics and anti-inflammatory treatments and the aforementioned heat-based therapies, over a period of at least 2 years

Disqualifiers

Fitzpatrick skin type V-VI

History of eyelid scarring

Infrared meibography evidence of significant acinar gland atrophy (dropout of >30%) - these patients have been shown not to benefit from heat-based therapies due to end-stage disease

Pregnancy or lactation

Trial design

Design model

Parallel

Treatments tested in this trial

The Thermage FLX System
Device
The Thermage FLX System is tested for its therapeutic efficacy and safety on treating refractory Meibomian Gland Dysfunction
Sham treatment
Device
Sham treatment acts as a control to test the therapeutic efficacy and safety of The Thermage FLX System

Treatment groups

112 Participants

are divided into 2 treatment groups

Group A: Radiofrequency treatment (RF), followed by meibomian gland expression (MGX)Experimental treatment 1 intervention

Group B: Sham treatment, followed by meibomian gland expression (MGX)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

Change in non-invasive keratographic tear breakup time (NIKBUT)

NIKBUT is measured in seconds and average of 3 consecutive readings is taken. Higher values mean better outcomes.

Time frame

From baseline to 6 months post- treatment between study groups

Secondary outcomes

Change in Standard Patient Evaluation of Eye Dryness (SPEED) symptom score

One number was collected per patient, with higher scores meaning worse outcomes

Time frame

From baseline to 6 months post-treatment between study groups

Percentage of subjects with normal non-invasive keratographic tear breakup time (NIKBUT)

\> 10 seconds, with lower scores meaning worse

Time frame

6 months

Percentage of subjects with normal SPEED

\<5, with higher scores meaning worse

Time frame

6 months

Change in best corrected visual acuity

from logmar(1.0 to -0.1)

Time frame