An innovative nonsurgical procedure, which delivers bipolar radiofrequency (RF) technology to delicate subdermal layers of the skin, may soon present optometrists with a new strategy to effectively treat dry eye disease and could enable them to branch into aesthetics.
RF devices deliver energy that differentially heats tissue by the impedance of the electromagnetic current. The differential heating across the tissue results are consistent with Ohms Law (Energy=Current x Impedance x Time).
A pilot study,1 published in The Open Ophthalmology Journal, demonstrated that RF treatment with the Envision Forma-I handpiece (InMode) along with meibomian gland expression, was “an effective means to reduce the signs and symptoms of dry eye disease”.
Additionally, data from the study supported “the conclusion that the treatment is safe and effective, lasting at least six months in most patients”.
Dry eye has traditionally been treated with drops, lid massage, warm compresses, and manual expression. More recently, LipiFlow (Morrisville, NC) and Intense Pulse Light (IPL) have emerged as promising technologies that work to heat the lid margin and help restore gland flow.
In their discussion, authors of the pilot study highlighted a meta-analysis of nine studies involving IPL that examined outcomes such as Patient Evaluation of Eye Dryness [SPEED] questionnaire, ocular surface disease index (OSDI), and tear breakup time (TBUT) in 539 patients. The results showed that IPL with meibomian gland expression (MGX) resulted in improvements in TBUT and OSDI, but not SPEED. They concluded that IPL alone was not superior to MGX, but symptoms could be reduced by combining the two, and that after three or four sessions, patients reported treatment efficacy lasting up to six months.
Reporting on a single treatment of RF-mediated eyelid heating using the Forma-I handpiece combined with MGX, they said patients experienced “significant improvement” across all endpoints including, SPEED, OSDI, TBUT, CFS, and MGS. Additionally, patients felt satisfied with the treatment and thought it resulted in improvement. No complications within the follow up period were reported.
About The Study
The multicentre prospective study (REF#7546-D0609175A), was performed from October 2019 to June 2022. Forty-seven patients were enrolled at three separate institutions by three ophthalmologists (oculoplastics, refractive, and general). If data points were unobtainable during the study, the patient was excluded from analysis.
Participants were aged 18–75 with TBUT ≤10 seconds; evidence of MG obstruction based on total MGS of ≤12 in lower eyelids for each eye; and subjective symptom score using SPEED questionnaire ≥10. They had at least one meibomian gland opening with a visible plugging over the eyelid margin and were not receiving treatment for any ocular pathology other than eye lubricant and conventional eyelid hygiene (within the last month and during the study).
Additionally, they were able to abstain from dry eye/meibomian gland dysfunction medications or any device treatments for the time between the treatment visit and the final study visit.
The study excluded participants with any intraocular inflammation, previous ocular surgery, ocular trauma in the past 12-months, ocular infection, eyelid structural abnormality, systemic diseases that lead to dry eye disease, skin cancer, pregnancy, or lactation.
The authors reported:
• Significant improvement in SPEED score from baseline, 15.7 vs 11.4 at one month, 9.1 at three months, and 9.6 at six months (p<0.05).
• Statistically significant improvement for OSDI at all time points measured, 34.5 at baseline vs 25.2 at one month, 21.2 at three months, and 23.6 at six months (p<0.5).
• Significantly reduced CFS in each eye at all time points following treatment, with 80% of eyes responding.
• Improved TBUT following treatment in each eye, with an average of 6.3 seconds at one month, 7.1 seconds at three months, and 7.1 seconds after treatment at six months vs 2.8 seconds at baseline.
• Marked improvement in MGS across all time points, 5.6 at baseline vs 19.9 at one month, 24.7 at three months, and 22.9 at six months.
• Additionally, patients noted subjective improvement, with lack of pain and discomfort from the treatment.
The authors also noted the potential to combine RF treatment with IPL, which treats at different cellular levels for dry eye and meibomian gland disease.
They wrote, “Interestingly, not only is there potential for medical improvement but there is also an improvement in skin quality, texture, and tone. Finally, a key component of therapeutic treatment was expression of the glands.
These clinical observations are promising from this pilot study that there is a reliable alternative treatment available for chronic dry eye patients.”
About Envision
Envision deploys multiple programmable modalities which work synergistically to deliver three precision treatments:
• Forma-I: bipolar radiofrequency (RF),
• Lumecca-I: intense pulse light (IPL), and
• Morpheus8: minimally invasive fractional technology.
With training, a ‘mid-level’ provider is able to perform the treatment. There is no need for topical anaesthetic or the use of corneal shields on the eyes.
Dr Bruce Dornn, an optometrist in Winnepeg, Canada, is a strong proponent of Envision. The owner of the Dornn Eye Care practice – a “dry eye centre of excellence”, he also sells dry eye treatments to consumers via his business Eye-Revive Inc.
Dr Dornn said his professional experience as an optometrist has demonstrated the efficacy of combining RF with MGX to treat dry eye disease.
He believes optometrists must be more proactive, by screening every adult patient for dry eye disease “as we do for glaucoma and macular degeneration”.
“Treat them while they are asymptomatic, treat them while the condition is very minor, get rid of the condition and they don’t ever experience a problem,” he said.
“There’s the medical model… a life of drops (which is) very expensive, or the procedural model – treating them with IPL/RF and manual gland expression.
Dr Dornn finds that combining RF with MGX “really moves the needle” for these patients.
“In Canada, we’re shifting away from the medical model (using drops and tears) to a treatment model using IPL/RF and MGX,” he said.
While IPL can break the inflammatory cycle, Dr Dornn said IRF works at a deeper level, to melt and express the meibum and get some of the collagen to function better.
“My goal is to get people producing their own tears – to get them off their drops.”
Noting the opportunity for optometrists to use IRL to expand into the realm of aesthetics, he said, “A lot of dry eye patients develop into patients who will now pay for aesthetics – because the results you get, particularly with rosacea, are phenomenal”.
