Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06278584 |
| Other study ID # |
2020001-00 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2020 |
| Est. completion date |
February 28, 2022 |
Study information
| Verified date |
February 2024 |
| Source |
Clínica de Oftalmología de Cali S.A |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Summary:
Purpose: To compare the safety and efficacy of eyelid treatment with the ILux®-MGD Treatment
System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in
patients with moderate to severe meibomian gland dysfunction (MGD).
Methods: Prospective, randomized, open-label, controlled clinical trial comparing one session
of the ILux® MGD Treatment System versus five sessions of MMGE in both eyes of 130 patients
aged ≥18 years with OSDI scores ≥13, total MGS of 15 in the lower lid of each eye and NI-TBUT
<10 s, who were randomized 1:1 to ILux® or MMGE.
Description:
Meibomian glands (MG) are responsible for the secretion of lipids (meibum) into the ocular
surface and have a protective role for tear film against evaporation1-4; therefore, Meibomian
Gland Dysfunction (MGD) is associated with evaporative dry eye (EDE). Hyperkeratinization and
hyperviscosity occur in dysfunctions with low MG expressibility, low meibum quality and
eyelid margin inflammation. Finally, atrophy and dropout of MGs in some cases could appear
MGD is a prevalent dry eye disorder (DED) with an estimated prevalence range between 3.5% and
70%1,10-13, it constitutes the primary underlying pathology within the EDE subtype. On top of
this, MGD is chronic and progressive, so it is imperative to identify clinical approaches
that can effectively target this underlying condition.
Treatment of MGD often involves artificial lubricants, topical lipid supplements, lid
hygiene, warm compression or heat application, supplement omega-3, topical and systemic
antibiotics against Demodex mite infestation, and steroids.
Mechanical management involves debridement-scaling of the line of Marx and lowers lid
margin21, and other methods for mechanical manual expression in alignment with the concept
that optimal treatment of MGD requires the employment of some forms of evacuating MGs
contents.
Eyelid thermal pulsation devices combine the application of heat at the appropriate
temperature to the palpebral surface with simultaneous compression of the glands to evacuate
their contents, and have been shown to improve signs and symptoms over 12 months in cases of
severe meibomian obstruction.
More recently, the ILux® MGD Treatment System (Alcon, FortWorth, TX, USA) is an eyelid
thermal pulsation system that includes a single-use patient interface device and a portable
battery-powered instrument that simultaneously applies localized heat and compression to
treat MGD and showed significant improvements in MG function between one and four weeks.
Prior to the introduction of vectored thermal pulsation therapies, the limitations of the
practice for mechanical meibomian gland expression (MMGE) were pain caused by forced
evacuation of the gland, difficulty with adequate sustained temperature at the eyelid at
therapeutic levels ≥ 40°C28, and duration of effect demonstrated in only one month. In the
patients five sessions per year of this combined treatment for moderate and severe DGM was
performet.
The aim of this study is to compare the safety and efficacy of one-session eyelid treatment
with the ILux® DGM treatment device versus five sessions in MMGE consultation in patients
with moderate and severe DGM in a follow-up.
