Recent research published in Clinical Ophthalmology evaluated Lumenis Be Ltd.’s dynamic muscle stimulation technology (DMSt) in its ability to improve two key symptoms in patients diagnosed with dry eye disease (DED) due to meibomian gland dysfunction (MGD).
First, a look at DED and MGD.
Described as a “multi-factorial disease” arising in large part from poor functioning of meibomian glands (MG) within the eyelids, evaporative DED typically leaves patients experiencing abnormal blinking—a result of lid laxity (droopy eyelids) and a reduction of muscle mass around the eyelids.
- Outside of DED, both conditions are associated with the natural aging process.
The traditional forms of correction: Surgical intervention such as blepharoplasty or canthoplasty to tighten the eyelids—which come with several potential complications and a lengthy recovery time.
- As such: a non-surgical approach is needed.
Enter this technology.
DMSt is a noninvasive treatment involving electrical impulses that trigger nerve signals to activate facial muscles, tightening and toning the underlying facial structure.
- In other words: It improves skin elasticity and increases muscle tone.
Notably: The tech is utilized in:
- Lumenis’ triLift for aesthetic purposes (toning the cheek, jowl line, and under-eye areas), with the resulting effect being a more natural, lifted look without surgical or injection interventions
- Lumenis’ OptiLIFT (launched earlier this year) to tighten and tone muscles within the periorbital area
So how was DMSt evaluated?
In a prospective, single-site, interventional, open-label clinical study (NCT05945069) that enrolled 30 participants (aged 67.0±12.1 years [min: 28.5, max: 84.7]).
A few specifics on this:
- The participants: Patients required to have:
- Diagnosis of DED due to MGD and lower lid laxity
- Moderate to severe Ocular Surface Index (OSD)
- Tear breakup time (TBIT) ≤ 5 seconds in both eyes
- The setup: Patients received DMSt treatment four times at 1-week intervals
- This involved the TriLift device—which combines DMS and radiofrequency (RF)—administered on the skin of the inferior orbital rim and below the lower eyelid
- The outcome measures: Tested prior to each of the four treatments as well as at the 4-week follow-up after the final treatment
- Primary: Impaired blink quality (determined via an abnormal lower lid distraction test [LLDT] or abnormal snap-back test [SBT])
- Others: Eyelid appearance; overall blink quality; margin-to-reflex distances (MRD1 and MRD2) of upper and lower lids to central corneal reflex; modified Meibomian Gland Score (MGS); OSDI; corneal sensitivity; blink rate; degree of eyelid closure; TBUT; adverse events (AEs); pain and discomfort; and best-corrected visual acuity (BCVA)
And the findings following these treatments?
At 1 month after the fourth (and final) treatment of the TriLift device, investigators found (compared to baseline):
- Patients with a normal LLDT and SBT increased to 80% (from 3%) and 93% (from 30%), respectively (p < 0.0001)
- Lower lid laxity decreased to 23% (from 100%) (p < 0.0001)
- MRD2 gradually decreased to 5.0 (standard deviation [SD] 0.4) mm from 5.5 (SD 0.9) mm (P < 0.001)
How about for those other outcomes?
Positive changes were noted, including (p < 0.001):
- +286% in TBUT
- -78% in mean MGS
- -53% in OSDI
Zero in on the eyelid now …
The number of patients with the following also increased:
- Normal eyelid appearance: 0 to 63% (p < 0.0001)
- Blink quality: 0 to 73% (p < 0.0001)
- Blink rate: 36% to 93% (p < 0.0001)
- Eyelid closure: 73% to 100% (p < 0.01)
As for AEs: None were reported.
So, in a nutshell?
By the follow-up period, eight patients who previously experienced incomplete closure of their eyelids had that abnormality decrease—while both eyelid appearance and blinking quality improved by 60% and 70% (respectively).
- Speaking of 60% … the number of patients with a normal blinking rate also increased by that percentage.
Plus: “Clinically significant improvements” were observed in both DED signs and symptoms (and no complications were noted).
Got it. And any limitations or unknowns to consider?
There always are. In this instance, a few notable limitations include that:
- The study did not have any preliminary estimation of size (and, thus, was not “powered”)
- The study didn’t include a control group, and its sample size was small
See here for the complete list.
Taking all of this into consideration, what was deduced?
To start, the study suggested that DMSt closes the gap in current (and historically standard) conservative approaches to treating lower lid laxity via its “proactive, non-invasive approach that may reduce the need for surgery,” according to Lumenis.
As for future research: Further studies are recommended to continue this investigation, particularly with:
- A larger sample size
- Longer follow-up
- A control group
- Additional clinical sites
- Quantitative measurements of blinking rate and quality
And the final takeaways?
Investigators included that DMSt reduces lower lid laxity and helps to improve three key areas: blink quality, MG function, and dry eye symptoms.
Further (as a contrast to similar technologies such as intense pulsed light [IPL] and RF), DMSt “can help address deficits in eyelid position and movement, particularly useful for older patients or those with floppy or mispositioned eyelids,” the study authors wrote.