Prospective evaluation of a new intense pulsed light, thermaeye plus, in the treatment of dry eye disease due to meibomian gland dysfunction

Abstract

Purpose This study aims to estimate the efficacy and safety of a new intense pulsed light (IPL) Thermaeye Plus for dry eye disease (DED) secondary to meibomian gland dysfunction (MGD). Patients and methods This is a prospective, longitudinal study of patients with moderate to severe MGD. Treatment consisted of 4 consecutive IPL sessions, 12 flashes with the same energy 8 J/cm 2 on the periocular area at days 1, 14, 28, and 49. All patients were evaluated before each IPL sessions and 1 and 4 months after the last session. Measuring: Symptoms score and OSDI questionnaire, Non-invasive tear meniscus height (NITMH), Non-invasive break up (NITBUT), Tear osmolarity (TO), Corneal fluorescein staining (CFS) and Eyelid margin and Meibomian gland assessment. The adverse effects on the eye, periocular area, and systemic complications were evaluated. All types of skin pigmentation (Fitzpatrick scale I to VI) were included. Results The study included 44 consecutive patients (88 eyes), 40 males and 48 females, with a mean age of 52.5 ± 13.6 years, ranging from 22 to 78 years. Significant improvements were observed in single and total signs and symptoms. The most significant changes were observed in dryness, foreign body sensation ( p < 0.001), and pain ( p < 0.005). The OSDI questionnaire showed a significant decrease in total symptoms ( p < 0.003). The percentage of patients with a normal index <13, improved from 23.8% (10 patients) at baseline to 80.9% (34 patients) at last visit, after 23 weeks. Clinical sings also improved, more than 90%, stand out telangiectasia and blepharitis ( p < 0.002, and p < 0.0005, respectively). No statistical differences between age (<40 y, 40–60 y, and >60 y) and gender were observed. The clinical improvement began after the second and third week after the first IPL session, until the end of the IPL treatment (D49). After that, the results maintained stable until the last visit, after 11 weeks. No complications were reported locally, nor in the periocular area as well as systemically. Conclusion Thermaeye Plus, a new IPL for ophthalmic use, is a safe and effective treatment in patients with DED due to MGD, showing improvement from the second week of treatment and maintaining until the last visit, 4 months after the last IPL session (23 weeks of total follow-up). Patients with pigmented skin (Fitzpatrick V or VI) have been treated with no side effects. It is relevant, especially to apply in brown-dark skin populations since complications with other IPL devices have been reported.

Characterization and Prediction of the Clinical Outcome of Intense Pulsed Light-Based Treatment in Dry Eye Associated to Meibomian Gland Dysfunction

“…This non-comparative prospective case series has shown, as in previous studies, that IPL-based therapy can be an effective treatment for dry eye with MGD associated [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. In agreement with the mechanism of action of the IPL technology, a significant change was observed in the secretion of the meibomian glands, with more eyes showing clear or yellow secretions after therapy.…”

“…Gupta et al [6] reported in a multicenter cohort study involving 100 patients with diagnosis of dry eye and MGD treated with IPL that there was a significant decrease in meibum viscosity scoring (mean: −1.1, range: −3 to 0) and a significant increase in oil flow score (mean: 0.9, range: −0.5 to 2.0). These changes in meibomian secretions are the responsible for the generation of a more consistent lipid layer [5,9,12] leading to increased values of BUT [5,8,9,[11][12][13][14][15]. In the current sample, no significant changes were detected in NIBUT.…”

“…In the current sample, a trend to reduction in the measurement of the NIBUT was also found, but only statistical significance was found in those changes detected in the left eye. It should be considered that the follow-up and method used to measure the NIBUT differ significantly among studies [5,6,8,9,[11][12][13][14][15]. Craig et al [5] found that NIBUT increased significantly from baseline to the end of treatment IPL sessions in a sample of 28 subjects participating in a contralateral study, but the tear evaporation rate did not differ significantly between treated and control eyes at any visit.…”

“…The analysis of the outcomes of IPL treatment in this last condition led to the discovery of the potential of this therapeutic option for the treatment of dry eye due to Meibomian gland dysfunction (MGD) [2][3][4]. Since then, a great variety of studies have been conducted to demonstrate the efficacy of IPL for the treatment of dry eye associated to MGD without [5][6][7][8][9][10][11][12][13][14][15][16] and with the combined meibomian gland expressibility (MGX) [17][18][19][20][21][22]. The American Academy of Ophthalmology have recently published a report on the efficacy of IPL treatment for MGD, concluding that the existing body of the scientific literature demonstrates improvements in the signs of symptoms of this condition, although methodological limitations and potential conflicts of interest were present in some studies [23].…”

“…This process is repeated in 2-4 sessions [29]. This irradiation of filtered polychromatic broad-bandwidth wavelengths with varying pulse durations generates various effects that contribute to its therapeutic properties: Meibomian glands warming that facilitates the expressibility and release of the meibum inside, improvement of the function of Meibomian glands, reduction of tear osmolarity, reduction of proinflammatory mediators contributing to dry eye, improvement of the cellular functions including fibroblasts regeneration, collagen synthesis, motility in immunoregulatory cells and photobiomodulation [15,30,31]. All these effects have a significant impact on different clinical measures.…”