LipiFlow Treatment Research Articles

Vectored Thermal Pulsation as a Treatment for Meibomian Gland Dysfunction: A Review Spanning 15 Years.

The LipiFlow Thermal Pulsation System received its first marketing clearance for the treatment of meibomian gland dysfunction (MGD) 13years ago. Since then, the evidence evaluating the effectiveness and safety of LipiFlow as a treatment for MGD has grown significantly. The objective of this comprehensive review was to summarize all clinical reports evaluating the effectiveness and safety of LipiFlow over the past 15years. The literature was systematically reviewed, and 55 unique articles had subjective (patient-reported outcomes) and objective (meibomian gland function, tear production, and ocular staining) outcomes for extraction. Data were collected from 2101patients and 3521 eyes treated with LipiFlow. Of these, effectiveness was evaluated in 2041patients and 3401 eyes, and safety was evaluated in 1448 patients and 2443 eyes. Taken together, the studies demonstrate that a single 12-min treatment with LipiFlow safely improves signs and symptoms of MGD and associated evaporative dry eye disease (DED), and the benefits persist up to 3years in some cases. The findings are corroborated by multiple meta-analyses and consensus guidelines. While some studies showed that daily eyelid hygiene, warm compress, and/or massage had a similar benefit to a single LipiFlow, these treatments were limited by inconvenience, discomfort, and non-compliance. The majority of studies evaluating safety reported no discomfort or pain associated with LipiFlow treatment, which supports the patient acceptability of LipiFlow therapy. All adverse events (AEs) related to LipiFlow were transient, non-vision-threatening, and did not require treatment. No studies reported serious AEs. The data obtained from 55 studies conducted globally overwhelmingly show that LipiFlow is effective and safe for the treatment of MGD and associated evaporative DED. The conclusions are supported by the diversity of the patient populations (geography, race, disease severity, and diagnosis), the large population treated with LipiFlow, the meta-analyses, and that this review analyzed all published clinical studies to date.

Meibography signal intensity as a novel image biomarker for meibomian gland function: evidence from cross-sectional and longitudinal analyses.

Meibomian gland dysfunction (MGD), one of the most common ocular surface diseases, can induce dry eye and reduce patients' quality of life. Methodological limitations have resulted in contradictory interpretations of gland function. This study sought to investigate the correlation between meibography signal intensity (SI) and meibomian gland (MG) function and to validate an MGD classification strategy based on different levels of SI. A multicenter, cross-sectional analysis was conducted on 817 eyes from 361 patients with MGD and 52 healthy controls. Additionally, 78 eyes from 39 patients with MGD who had undergone LipiFlow treatment were recruited for longitudinal analyses. The SI value was obtained via meibography using an automated analyzer, and all participants underwent ocular surface examinations. A cross-sectional analysis was performed to determine SI distribution and its relationship to clinical characteristics via a generalized estimating equation model. Longitudinal analyses were conducted on the treatment cohort using a mixed-effects model to explore the outcome in different SI levels. Regression analysis revealed significant correlations between SI and lipid layer thickness (β=0.016), meibum expressibility (β=-0.676), meibum quality (β=-0.251), and fluorescein-stained tear-film break-up time (FBUT) (β=0.064) (all P values <0.001 for the above associations). Low-level SI MGD cases exhibited the most severe clinical signs, including the worst meibum expressibility (16% for level 3) and quality scores (19% for level 3), the shortest FBUT (3.82±0.13 s), and the thinnest lipid layer (65.68±2.58 nm), (all P values <0.05, respectively). Patients with medium SI showed the lowest ocular surface disease index (OSDI) value (26.64±1.06), the longest FBUT (4.56±0.08 s), and the thickest lipid layer (80.20±2.90 nm). After treatment, the high SI values reduced significantly at each follow-up point compared to baseline (all P values <0.05). The medium SI group demonstrated the greatest improvement in symptoms and signs, followed by the high SI group, and the low SI group. Automated measurements of SI can effectively reflect MG secretory activity. The proposed low, medium, and high SI classifications represent different functional subtypes of MGD.

Comparison of a single-dose vectored thermal pulsation procedure with 5-day course of daily oral azithromycin for meibomian gland dysfunction.

This study aims at comparing the efficacy of a single-dose vectored thermal pulsation (VTP) procedure versus 5 days once daily oral azithromycin in patients with meibomian gland disease (MGD) by measuring the symptomatology and ocular surface parameters. The study was conducted as a prospective, nonrandomized, comparative study over a period of 17 months at a tertiary care center. In this study, 60 patients with MGD were enrolled after they gave their informed consent according to the inclusion-exclusion criteria and were divided into two groups, 30 each in the azithromycin group and the VTP, i.e., the LipiFlow group. One group was treated with oral azithromycin for 5 days and the other group was given LipiFlow treatment. Postprocedure, follow-up was done for 2 weeks, 3 months, and 6 months. A statistically significant difference was noted in the score Standard Patient Evaluation of Eye Dryness questionnaire after 3 months of treatment in both the azithromycin and LipiFlow group (P < 0.0001), and the LipiFlow group showed sustained improvement at 6-month follow-up as score improved to 8.83 ± 2.32, whereas it deteriorated in azithromycin group to 13.77 ± 1.65. Pretreatment Ocular Surface Disease Index score (P = 0.126) and posttreatment (P < 0.0001) showed significant differences in both groups. The LipiFlow group showed an improved score of 25.65 ± 6.11 after 6 months of treatment, whereas it deteriorated to 34.79 ± 4.98 in the azithromycin group. Pretreatment, tear film break-up time (P = 0.28) and 6 months posttreatment score (P < 0.0001) showed significant differences in both groups, but in the LipiFlow group, it improved to 15.30 ± 1.76 after 6 months, whereas in the azithromycin group, it was 10.07 ± 1.60. The pretreatment MG score was 4.10 ± 0.99 and 4.23 ± 1.07 (P = 0.62) in the azithromycin and LipiFlow group, respectively. After 2 weeks, 3 months, and 6 months, the MG score was 24.20 ± 3.38, 21.67 ± 3.46, and 15.83 ± 2.41, respectively, in azithromycin group. In the LipiFlow group, the score was 13 ± 1.88, 14.27 ± 2.07, and 14.37 ± 1.85 at 2 weeks, 3 months, and 6 months, respectively, suggestive of improvement in all visits. Both oral azithromycin and LipiFlow treatment are effective in patients with MGD. The effect of LipiFlow treatment lasted longer as compared to azithromycin. The efficacy of azithromycin in resolving the symptoms of MGD was greater compared to LipiFlow in the initial 2 weeks of treatment. However, the effect deteriorated in the subsequent follow-up at 3 months and 6 months.

Preoperative Treatment of Meibomian Gland Dysfunction with a Vectored Thermal Pulsation System Prior to Extended Depth of Focus IOL Implantation.

Patients implanted with a range-of-vision intraocular lens (IOL) (multifocal or extended depth of focus, EDOF) may be more susceptible to visual disturbances from poor tear film quality, and prophylactic treatment of meibomian gland dysfunction (MGD) has been recommended. The purpose was to evaluate whether vectored thermal pulsation (LipiFlow™) treatment prior to cataract surgery with a range-of-vision IOL safely improves postoperative outcomes. This is a prospective, randomized, open-label, crossover, multicenter study of patients with mild-to-moderate MGD and cataract. The test group underwent LipiFlow treatment prior to cataract surgery and implantation of an EDOF IOL, while the control group did not. Both groups were evaluated 3months postoperatively, after which the control group received LipiFlow treatment (crossover). The control group was re-evaluated 4months postoperatively. A total of 121 subjects were randomized, with 117 eyes in the test group and 115 eyes in the control group. At 3months after surgery, the test group had a significantly greater improvement from baseline in total meibomian gland score compared with the control group (P = 0.046). At 1month after surgery, the test group had a significant decrease in corneal (P = 0.04) and conjunctival (P = 0.002) staining compared to the control group. At 3months after surgery, the test group had significantly lower incidence of being bothered by halos compared with the control group (P = 0.019). The control group had a significantly lower incidence of being bothered by multiple or double vision compared with the test group (P = 0.016). After crossover, patients had significant improvement in vision (P = 0.03) and total meibomian gland score (P < 0.0001). No safety concerns or relevant safety findings were uncovered. Presurgical LipiFlow treatment of patients implanted with range-of-vision IOLs improved meibomian gland function and postoperative ocular surface health. This supports guidelines recommending proactive diagnosis and management of MGD in patients with cataracts to improve patient experience. The study was registered on www. gov (NCT03708367).

Efficacy of Vector Thermal Pulsation treatment in reducing post-cataract surgery dry eye disease in patients affected by meibomian gland dysfunction.

To evaluate the effect of a single LipiFlow vector thermal pulsation treatment (Johnson & Johnson) performed before cataract surgery in reducing signs and symptoms of postoperative dry eye disease (DED) in patients with mild-moderate meibomian gland dysfunction (MGD). Eye Clinic, Careggi Hospital, University of Florence, Florence, Italy. Prospective, unmasked, randomized, controlled clinical trial. This study included patients affected by age-related cataract and mild-moderate MGD, who were randomized in two groups: 1) A single LipiFlow treatment performed at 5 preoperative weeks; 2) Warm compresses and eyelid massages twice a day for one preoperative month (control group). Non-invasive break-up time (NI-BUT), Schirmer test, SPEED questionnaire and MG functionality parameters were evaluated at Visit 0 (5 preoperative weeks), Visit 1 (1 preoperative week), Visit 2 (1 postoperative month). Confocal microscopy of MG of lower eyelids was performed at visit 0 and visit 2. In the LipiFlow group (n=23) NI-BUT, SPEED questionnaire, MG functionality parameters significantly improved at Visit 1 (p<0.05) and Visit 2 (p<0.05) compared to baseline and remained stable after surgery. In the control group (n=23) they did not significantly improve after treatment, while worsened after surgery. Moreover, the changes in all parameters from baseline were significantly different between the two groups. Confocal microscopy imaging highlighted lower post-operative MG alterations in the Lipiflow group. A single preoperative LipiFlow treatment was effective in preventing post-cataract surgery DED in patients with mild-moderate MGD. After surgery, treated patients displayed a better ocular surface status compared to warm compresses.

Effect of a single vectored thermal pulsation treatment of Meibomian gland dysfunction patients under controlled environmental conditions

To assess the prophylactic effect of LipiFlow treatment in Meibomian gland dysfunction (MGD) patients exposed to an adverse environmental humidity. MGD patients were exposed to normal (23 °C; 50% relative humidity; 30 min) and adverse (23 °C; 10% relative humidity; 2 h) controlled environments consecutively during baseline and follow-up visits (3, 6, and 12 months) after a single LipiFlow treatment. Ocular Surface Disease Index (OSDI), lipid layer thickness (LLT), fluorescein tear break-up time (TBUT), corneal and conjunctival staining, change in dry eye symptoms questionnaire (CDES-Q), and Meibomian gland yielding liquid secretion (MGYLS), were assessed. Linear mixed-effects and cumulative logit mixed models were fitted to assess the effect of the LipiFlow treatment over time and within the controlled environments. Seventeen females and 4 males (59.6 ± 9.4 years) completed the study. LLT and TBUT did not vary significantly (p > 0.05) after LipiFlow treatment. OSDI, corneal and conjunctival staining, and MGYLS scores were improved (p ≤ 0.01) 12 months after treatment. After the adverse exposure, corneal staining increased at all visits (p = 0.01), and there was no significant improvement in CDES-Q scores after LipiFlow treatment (p ≥ 0.07). One LipiFlow treatment improved objective and subjective outcomes in MGD disease for at least one year. Further studies are needed to support that LipiFlow might also help as an adjuvant to avoid acute flares against an adverse environmental humidity.

Efficacy and Safety evaluation of a single thermal pulsation system treatment (Lipiflow®) on meibomian gland dysfunction: a randomized controlled clinical trial.

Evaluate the efficacy and safety of LipiFlow® thermal pulsation treatment system compared with lid massage combined warm compress in Chinese patients with meibomian gland dysfunction (MGD). Patients (n = 100 eyes, 50 subjects) diagnosed with MGD were recruited for this prospective, randomized, 3-month clinical trial. In Lipiflow group, patients (n = 50 eyes) received a single LipiFlow® thermal pulsation system treatment. In warm compress group, patients (n = 50 eyes) underwent warm compress daily for two weeks after an initial manual lid massage. Patients' symptoms were evaluated using Standard Patient Evaluation for Eye Dryness (SPEED) questionnaire. Safety parameters included best-corrected visual acuity (BCVA), intraocular pressure (IOP) and objective parameters including meibomian glands yielding lipid secretion (MGYLS) number, meibomian glands secretion (MGS) score, lipid layer thickness (LLT), tear-film breakup time (TBUT), corneal fluorescein staining (CFS) were measured and presented from baseline and to 3months post-treatment. Baseline parameters in both groups were comparable (p > 0.05). SPEED score and TBUT improved in two groups from baseline to 3months. MGYLS number, MGS score, LLT improved in LipiFlow group and these improvements were maintained with no significant regression at 3months. CFS showed significant improvement in warm compress group at 1month compared with LipiFlow group. Moreover, the correlation analysis indicated LLT was positively correlated with TBUT, MGS score, and MGYLS number. A single 12-min LipiFlow treatment is an effective therapy for MGD patients and can achieve improvements in symptoms alleviation and meibomian gland lipid secretion function lasting for at least 3months.

A Comparison of TearCare and Lipiflow Systems in Reducing Dry Eye Disease Symptoms Associated with Meibomian Gland Disease

PurposeTo compare TearCare and Lipiflow systems in the ability to reduce the symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).MethodsIn this multicenter, masked, randomized-controlled trial, 235 subjects received a single TearCare treatment (n = 115) or a single LipiFlow treatment (n = 120) and were followed for 1-month post-treatment. DED symptoms were assessed using the Ocular Surface Disease Index (OSDI), Symptom Assessment in Dry Eye (SANDE), and Eye Dryness (ED) questionnaires at baseline and at 1 month. Post-hoc subgroup analysis was conducted on subjects with less severe and more severe gland obstruction determined by baseline meibomian gland secretion score (MGSS).ResultsTearCare system significantly improved total OSDI, SANDE, and ED scores from baseline (p < 0.0001) at 1-month follow-up. Subjects with more severe disease (MGSS <7) achieved statistically greater reduction with TearCare compared to LipiFlow in total OSDI score (30.4 ± 2.53 and 21.9 ± 2.37, respectively, pANCOVA = 0.0160), OSDI Section B score for quality of vision (5.1 ± 0.48 and 3.6 ± 0.45, respectively, pANCOVA= 0.0206), and SANDE frequency score (51.9 ± 3.70 and 41.5 ± 3.45, respectively, pANCOVA = 0.0455).ConclusionTearCare provides significant DED symptom relief at 1 month after a single treatment. Outcomes were consistent in OSDI, SANDE, and ED assessments. In subjects with more severe gland dysfunction, TearCare performed significantly better than LipiFlow in improving quality of vision and overall DED symptom frequency determined by OSDI and SANDE.Clinical Trial Registration NumberNCT03857919.

Effects of Lipiflow Treatment Prior to Cataract Surgery: A Prospective, Randomized, Controlled Study

Prospective, randomized controlled study. This study comprised 124 eyes of 124 patients with planned surgery for senile cataract. Participants were randomly allocated into control and Lipiflow groups based on administration of Lipiflow treatment 3 weeks before cataract surgery. For meibomian gland (MG) evaluation, MG atrophy, degree of gland expressibility, and quality of gland secretions were examined at the baseline visit and 1 and 3 months postoperatively. Ocular surface parameters of tear film break-up time, Oxford corneal staining score, and tear film lipid layer thickness were measured at each visit. Ocular Surface Disease Index and Dry Eye Questionnaire were also assessed. The control group exhibited a significant decrease in MG expressibility, worsened meibum quality, decreased lipid layer thickness, and worsened corneal staining after cataract surgery. Also, dry eye symptom showed significant worsening. Conversely, the Lipiflow group showed significantly improved MG patency and meibum quality, increased tear film break-up time, and reduced corneal staining, and presented improved subjective outcomes reported on both Ocular Surface Disease Index and Dry Eye Questionnaire. The improvement of each parameter in the Lipiflow group showed a linear correlation with baseline MGD grade. In addition, patients without baseline MGD showed less worsening or improvement of MGD and dry eye induced by surgery, with preoperative Lipiflow treatment. Preoperative Lipiflow treatment conducted before cataract surgery may be a safe and effective intervention for relieving MGD and dry eye induced by surgery. It might be recommended not only for the patients with preoperative MGD but also for those without baseline MGD, to prevent the development of MGD and dry eye induced by ocular surgeries.

Preoperative Management of MGD with Vectored Thermal Pulsation before Cataract Surgery: A Prospective, Controlled Clinical Trial

ABSTRACT Purpose: To investigate the efficacy of preoperative monocular treatment in elderly cataract patients with Meibomian Gland Dysfunction (MGD) utilizing vectored thermal pulsation treatment. Materials and Methods: This study was a prospective, examiner-masked contralateral eye clinical trial. Patients previously diagnosed with MGD undergoing uncomplicated cataract surgery in two eyes were enrolled. The eye perceived by the patient to be more symptomatic of MGD received a 12 min vectored thermal pulsation treatment using the LipiFlow Thermal Pulsation System, and was referred to as the LipiFlow-surgery eye. The contralateral eye then served as the nonLipiFlow-surgery eye. Patients with MGD not undergoing cataract surgery were enrolled as the control group. Within the control group, the eye that received LipiFlow treatment was considered the LipiFlow-nonsurgery eye, while the contralateral eye served as the nonLipiFlow-nonsurgery eye. All patients were examined before treatment and at one-week, one-month, and three-month intervals after treatment. Clinical parameters included dry eye symptoms, average lipid layer thickness (LLT-ave), tear breakup time (TBUT), corneal staining, Schirmer I tests, Meibomian glands yielding liquid secretion (MGYLS), and meibomian gland dropout. Results: A total of 32 patients (64 eyes) were examined during the three-month follow-up. There was a significant reduction in dry eye symptoms in non-surgery patients with monocular treatment of MGD, while no change in surgery patients was observed. Significant improvement of MGYLS in LipiFlow-surgery and LipiFlow-nonsurgery eyes during the follow-up time (p < .001) was reported, while no difference was observed in nonLipiFlow-surgery and nonLipiFlow-nonsurgery eyes. A statistically significant difference was seen in TBUT between LipiFlow-surgery and nonLipiFlow-surgery eyes at one-week and one-month intervals (p = .019 and 0.019, respectively). Differences in other clinical parameters were not statistically significant. Conclusions: Our findings suggest that although subjective symptoms were not alleviated, a single application of LipiFlow treatment before cataract surgery is effective in alleviating blockage of meibomian glands and preventing the decline of TBUT after cataract surgery.

Pellevé™ vs Lipiflow™ MGD-Related Dry Eye Treatment Study: The ThermaLid™ Procedure

Objective: To assess the safety and efficacy of the Pellevé Wrinkle Treatment System as compared to LipiFlow, for treatment of dry eye syndrome due to meibomian gland dysfunction (MGD).&#x0D; Materials and Methods: In this split face, randomized study, ten patients who met specific criteria for inclusion were followed after treatment with the Pellevé Wrinkle Reduction System (what the authors have dubbed the "thermaLid Procedure") and a standard LipiFlow procedure performed the same day, with 1 and 3 months follow-up. Pre- and post- treatment MGD was assessed using a variety of subjective and objective measurements. &#x0D; Results: The function of the meibomian glands improved significantly from baseline to 3 months for both thermaLid and Lipiflow treated eyes, with no significant difference between them, as measured by MGE grading, wax plug scoring, Standard Patient Evaluation of Eye Dryness (SPEED) and Ocular Surface Disease Index (OSDI) scoring. A significant change in conjunctival staining was found after both treatments at the 1-month time point but not the 3-month time point. thermaLid but not Lipiflow treatment, significantly decreased MARX line measurements at 3-months. Lipiview, Non-Invasive Tear Breakup Time (NITBUT), corneal surface staining, Tear Osmolarity, and anesthetic Schirmer's testing did not show statistically significant improvement, nor differences between treatment modalities.&#x0D; Conclusions: thermaLid treatment of the eyelids appears to show efficacy similar to Lipiflow treatment in reducing symptoms, reducing wax plugging and improving the number of functioning MGs as well as reducing conjunctival staining in MGD related dry eye disease.

Meibomian gland dysfunction patients with novel Sj&amp;ouml;gren&amp;rsquo;s syndrome biomarkers benefit significantly from a single vectored thermal pulsation procedure: a retrospective analysis

PurposeTo measure the effects from a single vectored thermal pulsation treatment of the meibomian glands on dry eye signs and symptoms in patients who tested positively versus negatively for novel Sjögren’s syndrome (SS) biomarkers.MethodsThe retrospective study included the deidentified data of 102 eyes of 59 patients with dry eye and meibomian gland dysfunction (MGD), who were also tested for novel biomarkers for SS and underwent a single 12-minute LipiFlow thermal pulsation procedure. All patients were already being treated with individualized dry eye therapy but remained symptomatic. Meibomian gland secretion (MGS) scores, Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores and tear breakup times (TBUTs) before and 8 weeks after thermal pulsation treatment were analyzed.ResultsTwenty-three patients tested positive for novel biomarkers of SS and 36 patients tested negative. At baseline, MGS, SPEED and TBUT of both SS-positive and SS-negative patients were equivalent. At 8 weeks’ post-treatment, mean MGS score, SPEED and TBUT were 13.0±7.8, 12.5±6.8 and 9.6±4.6, respectively, in SS-positive patients and 15.9±7.9, 10.0±6.3 and 8.3±4.6, respectively, in SS-negative patients (P<0.001). While the post-treatment MGS was significantly better in SS-negative patients than SS-positive (P=0.021), no significant difference between post-treatment SPEED and TBUT was observed between the two groups (P>0.05).ConclusionLipiFlow treatment in MGD patients who were SS-positive for novel biomarkers of SS demonstrated improvement in signs and symptoms of dry eye. While improvement in MGS scores in SS-negative patients was higher than that observed in SS-positive patients, SPEED and TBUT were equivalent between these two groups.

Evaluation of Monocular Treatment for Meibomian Gland Dysfunction with an Automated Thermodynamic System in Elderly Chinese Patients: A Contralateral Eye Study

Purpose. To investigate the safety and efficacy of monocular treatment for elderly Chinese patients with meibomian gland dysfunction (MGD) with an automated thermodynamic system. Methods. This study was a prospective, examiner-masked, contralateral eye clinical trial. The eye perceived by the patient to be worse (test eye) received a 12-minute LipiFlow treatment, while the other eye served as control. All patients were examined before treatment and one week, one month, and three months after treatment. Clinical parameters included dry eye symptoms, lipid layer thickness (LLT), partial blink (PB) ratio, invasive tear breakup time (ITBUT) and cornea staining, Schirmer I test, meibomian glands yielding liquid secretion (MGYLS), and meibomian gland dropout. Results. A total of 29 patients were examined during the three-month follow-up. At each posttreatment visit, they had a significant reduction in dry eye symptoms accompanied by an increase of ITBUT and MGYLS and a reduction in corneal staining compared with the baseline parameters. There was a significant improvement in MGYLS and ITBUT in the test eye compared with the control eye. Other clinical parameters were not statistically significant. Conclusion. LipiFlow is an effective treatment for patients with MGD. Monocular treatment with LipiFlow may be a cost-effective treatment option to those afflicted with MGD in the developing world.

Evaluation of an Automated Thermodynamic Treatment (LipiFlow®) System for Meibomian Gland Dysfunction: A Prospective, Randomized, Observer-Masked Trial

PurposeTo compare the effectiveness of a single LipiFlow® treatment with combined lid warming and massage in patients with meibomian gland dysfunction (MGD). MethodsIn this prospective, randomized, crossover, observer-masked clinical trial, subjects were randomized to receive either a single 12-min LipiFlow-LipiFlow Thermal Pulsation (LTP) system treatment or to perform combined twice-daily lid warming and massage for 3 months. All subjects were examined before, and 1 and 3 months after initiation of treatments. Investigated parameters included subjective symptoms, lipid layer thickness, meibomian gland assessment, tear break-up time, tear osmolarity, corneal and conjunctival staining, Schirmer test values, and tear meniscus height. ResultsA total of 31 subjects completed the 3-month follow-up. At 1 and 3 months, patients in the LipiFlow treatment group had a significant reduction in Ocular Surface Disease Index (OSDI) scores compared with those in the lid-margin hygiene group. Both treatments produced a significant improvement in expressible meibomian glands compared to the baseline parameters, but no significant difference was noted between the two groups. The other investigated objective parameters did not show a significant difference. ConclusionResults of our study show that a single LipiFlow treatment is as least as effective as a 3-month, twice-daily lid margin hygiene regimen for MGD. However, the present study was observer-masked only, and therefore a placebo effect may have confounded any improvements in subjective symptoms and other parameters in both groups.

A Systematic Approach to Dry Eye using LipiFlow Treatment

The complex strategy to understanding dry eye syndrome has led to a widespread change in approaching this condition as an ocular surface disease, stratified as evaporative dry eye, aqueous deficient dry eye, and ocular allergy. The diagnostic armamentarium has vastly expanded to include tear osmolarity and inflammatory markers as redefined by the new International Dry Eye WorkShop (DEWS) in 2007. The Tear Film &amp; Ocular Surface Society (TFOS) panel on meibomian gland dysfunction (MGD) further expanded the interpretation of evaporative dry eye and its therapeutic options, including the newest US Food and Drug Administration (FDA)-approved device known as LipiFlow Thermal Pulsation System. This paper will give an overview on understanding dry eye disease, its etiology, diagnostic methods, and current therapeutic options.

Case Report

The aim of this study was to investigate whether a single case of meibomian gland dysfunction (MGD), with significant MG dropout resulting in evaporative dry eye, could be effectively treated with the LipiFlow (a new Food and Drug Administration-approved thermodynamic pulsatile treatment). A 39-year-old white woman experienced severe dry eye symptoms because of MGD with considerable MG dropout resulting in evaporative dry eye. Standardized diagnostic MG expression and meibography led to the tentative diagnosis of nonobvious MGD (only 1 functional MG on each lower lid) and MG dropout (∼50% of the lower lid MGs were missing with the remaining MGs being severely truncated). The patient underwent a single 12-min LipiFlow treatment per eye and returned for follow-up at 1 and 7 months posttreatment. The LipiFlow treatment increased the number of functional lower lid MGs from 1 to 5 glands OD and 1 to 7 glands OS at 1 month with slight regression at 7 months (4 OD and 4 OS); increased fluorescein break-up time from 4 to 7 sec OD and 4 to 9 sec OS at both 1 and 7 months; and decreased symptom scores by approximately 50% at 1 month and approximately 75% at 7 months. These results demonstrate the effectiveness of the LipiFlow in restoring MG function and improving ocular comfort even in this particular case of significant MG dropout and MG truncation.

A New System, the LipiFlow, for the Treatment of Meibomian Gland Dysfunction

To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress (WC) for adults with meibomian gland dysfunction (MGD). This was a non-significant risk, prospective, open-label, randomized, crossover multicenter clinical trial. One hundred thirty-nine subjects were randomized between LipiFlow (n=69) and WC control (n=70). Subjects in the LipiFlow group received a 12-minute LipiFlow treatment and were reexamined at 1 day, 2 weeks and 4 weeks. Control subjects received a 5-minute iHeat treatment with instructions to perform the same treatment daily for 2 weeks. At 2 weeks, they crossed over (LipiFlow Crossover) and received the LipiFlow treatment. Effectiveness parameters: meibomian gland (MG) assessment, tear break-up time (TBUT) and dry eye symptoms. Safety parameters: adverse events, ocular health exam, ocular surface staining, intraocular pressure, visual acuity and discomfort. LipiFlow resulted in significant improvement (P < 0.05) in MG secretion at 2 and 4 weeks (mean ± standard deviation at baseline = 6.3 ± 3.5; 2 weeks = 14.3 ± 8.7; 4 weeks = 16.7 ± 8.7); and TBUT at 2 and 4 weeks: (at baseline = 5.5 ± 2.9; 2 weeks = 6.9 ± 5.0; 4 weeks = 7.4 ± 5.5). There was no significant change in MG secretion or TBUT in the control group. LipiFlow resulted in a greater significant reduction in dry eye symptoms than the iHeat WC. The crossover group demonstrated similar significant improvement 2 weeks post-treatment with the LipiFlow. There was no significant difference between groups in the incidence of non-serious, device-related adverse events. The LipiFlow System was significantly more effective than iHeat WC. These results support its safety and effectiveness in the treatment of MGD and dry eye symptoms.