New advances in medical management of dry eye: optimizing treatment strategies for enhanced relief.

PURPOSE: Dry eye disease (DED) is a prevalent ocular surface disease that is conventionally characterized by tear film hyperosmolarity and instability. This review presents a summarized classification of DED, followed by a comprehensive discussion of the most recent topical and systemic medications and clinical recommendations for selecting the most appropriate option for each patient. METHODS: An extensive literature search was conducted on electronic databases, such as PubMed, Scopus, and Web of Science, using keywords including "dry eye syndrome," "ocular surface disease," "medical management," "artificial tears," "topical immunomodulators," and "meibomian gland dysfunction." RESULTS: The underlying reasons for DED can range from insufficient aqueous tear production to increased tear evaporation. Recent literature has provided a more in-depth understanding of the pathophysiology of DED by examining the tear film's lipid, aqueous, and mucin layers. However, despite these advancements, medical management of patients with symptomatic DED has not fully reflected this modernized knowledge of its pathophysiology. CONCLUSION: To develop a rationalized strategy for treating DED, it is crucial to have updated knowledge of therapeutic options, their mechanisms of actions, and indications based on the DED type and underlying causes.

Prevalence of dry eye and Meibomian gland dysfunction in Central and South America: a systematic review and meta-analysis.

BACKGROUND: Dry eye is one of the most common ophthalmic conditions and can significantly impact quality of life. Meibomian gland dysfunction (MGD) is a major cause of evaporative dry eye. We sought to conduct a systematic review and meta-analysis to estimate the prevalence and incidence of dry eye and MGD in Central and South America and to identify factors associated with disease burden. METHODS: Data sources Ovid MEDLINE and Embase. STUDY SELECTION: A search conducted on August 16, 2021, identified studies published between January 1, 2010, and August 16, 2021, with no restrictions regarding participant age or language of publication. Case reports, case series, case-control studies, and interventional studies were excluded. DATA EXTRACTION AND SYNTHESIS: The review was based on a protocol registered on PROSPERO (CRD42021256934). Risk of bias was assessed in duplicate using a risk of bias tool designed for the purposes of descriptive epidemiological studies. Data were extracted by one investigator and verified by another for accuracy. Prevalence of dry eye and MGD were grouped based on study participant characteristics. MAIN OUTCOMES AND MEASURES: Prevalence and incidence of dry eye and MGD in Central and South America. Summary estimates from meta-analysis with 95% confidence intervals (CI). RESULTS: Fourteen studies (11,594 total participants) were included. The population prevalence of dry eye was 13% (95% CI, 12%-14%) in Brazil and 41% (95% CI, 39%-44%) in Mexico based on one study each. Meta-analyses suggested that dry eye prevalence was 70% among indoor workers (95% CI, 56%-80%; I2, 82%; 3 studies), 71% among students (95% CI, 65%-77%; I2, 92%; 3 studies), and 83% in general ophthalmology clinics (95% CI, 77%-88%; I2, 88%; 2 studies). MGD prevalence ranged from 23% among indoor workers (95% CI, 16%-31%; 1 study) to 68% in general ophthalmology clinics (95% CI, 62%-72%; 1 study). No studies reported incidence of dry eye or MGD. CONCLUSIONS: This systematic review and meta-analysis demonstrated considerable variation in the published prevalence of dry eye and MGD among the general population and subpopulations in Central and South America. Local and subpopulation estimates of dry eye disease burden may be valuable to assist needs assessments and implementation of measures to mitigate the condition.

[Acaricidal therapy in chronic demodex blepharitis and meibomian gland dysfunctions]. / Akaritsidnoe lechebnoe vozdeistvie pri khronicheskom demodekoznom blefarite i disfunktsii meibomievykh zhelez.

PURPOSE: The study comparatively evaluates the effectiveness of various approaches to acaricidal treatment in patients with chronic demodex blepharitis and meibomian gland dysfunctions. MATERIAL AND METHODS: The study included 40 patients with chronic blepharitis (CB) of demodicosis etiology in conditions of meibomian gland dysfunction (MGD) and dry eye (DE). The 1st group of patients (20 people) received acaricidal treatment as part of therapeutic eyelid hygiene (TEH; 2 times a day) involving the use of «Blefarogel ochishchenie¼, «Blefarolosion¼, «Blefarogel forte¼ (contains sulfur and metronidazole). Acaricidal treatment in the patients of the 2nd group involved applications of a product containing metronidazole (2 times a day) without TEH. Control points: 1) at inclusion in the study; 2) after a course of therapy (45 days). Evaluation included: patient acarograms, symptoms and signs of CB (points); OSDI; tear film break-up time (TBUT, sec), severity of meibomian gland dysfunction (S-MGD, points). Statistical analysis: calculation of M±SD, Mann-Whitney, and Wilcoxon tests. RESULTS: Acaricidal treatment was effective in both groups (reduction in demodex population, which was more pronounced in the 1st group). Symptoms and signs of CB were significantly less pronounced in the patients of the 1st group after therapy. The patients of the 1st group showed a significant decrease in S-MGD, OSDI and an increase in TBUT, the 2nd group - a significant decrease in OSDI and an increase in TBUT at the second control point. The positive OSDI and TBUT trends were significantly more pronounced in the 1st group. CONCLUSION: Acaricidal treatment as part of TEH showed a significantly more pronounced reduction in demodex population, relief of CB symptoms and sign, OSDI decrease and TBUT increase, compared to the 2nd group. Apparently, this was associated with combined acaricidal effect and significant S-MGD decrease in the patients of the 1st group.

Meibomian gland dysfunction and blepharitis: A common and still unsolved ophthalmic problem.

Blepharitis and meibomian gland dysfunction (MGD) are very common, usually underdiagnosed and underappreciated diseases. More than 50% of patients seeking ophthalmologic consultations have symptoms and signs indicating one or both entities. We summarize the key points of diagnosis and management of both diseases, comparing the work of Dry Eye Workshop II (2017) with the dry eye blepharitis syndrome unification theory. The impact of MGD/blepharitis on ocular surgery also is described. Although MGD and blepharitis seem to be uncurable, most of the time they can be successfully controlled. Different management options are available, but the key to success remains simple-routine eyelid hygiene and moisturizing with the use of preservative-free lubricants.

Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients: A Randomized Clinical Trial.

Importance: Meibomian gland dysfunction (MGD) is a leading cause of evaporative dry eye disease (DED). Medical and surgical management for DED is limited; therefore, new treatment options are sought. Objective: To evaluate the efficacy and safety of SHR8058 (perfluorohexyloctane) eye drops in Chinese patients with DED associated with MGD through 57 days. Design, Setting, and Participants: This was a randomized, multicenter, double-masked, saline-controlled, phase 3 clinical trial conducted from February 4, 2021, to September 7, 2022. Patients were recruited from the departments of ophthalmology in 15 hospitals in China. Patients with DED associated with MGD were enrolled between February 4 and July 1, 2021. The diagnosis was based on patient complaint of DED symptoms, an ocular surface disease index of 25 or higher, tear film break-up time of 5 seconds or less, Schirmer I test without anesthesia results of 5 mm or more at 5 minutes, total corneal fluorescein staining (tCFS) score of 4 to 11, and an MGD score of 3 or higher. Interventions: Eligible participants were randomly assigned 1:1 to receive perfluorohexyloctane eye drops or 0.6% sodium chloride [NaCl]) 4 times per day. Main Outcomes and Measures: The primary end points were the changes from baseline in tCFS and eye dryness scores at day 57. Results: A total of 312 participants were included in the analysis: 156 (mean [SD] age, 45.4 [15.2] years; 118 female [75.6%]) in the perfluorohexyloctane group and 156 (mean [SD] age, 43.7 [15.1] years; 127 female [81.4%]) in the NaCl group. Both primary end points were achieved, ie, changes from baseline at day 57 of tCFS score (mean [SD], -3.8 [2.7] vs -2.7 [2.8]) and eye dryness score (mean [SD], -38.6 [21.9] vs -28.3 [20.8]) in the perfluorohexyloctane group were superior to the control group, with estimated mean differences of -1.14 (95% CI, -1.70 to -0.57; P < .001) and -12.74 (95% CI, -17.20 to -8.28, P < .001), respectively. Improvements on both end points appeared to be noted on day 29 and day 15, respectively, and maintained through day 57. Compared with the control, perfluorohexyloctane eye drops also alleviated symptoms including pain (mean [SD] tCFS score, 26.7 [23.7] vs -18.7 [22.5]; P = .003), awareness of DED symptoms (mean [SD] tCFS score, -38.1 [25.1] vs -23.7 [27.6]; P < .001), and frequency of dryness (mean [SD] tCFS score, -43.3 [23.8] vs -29.1 [24.8]; P < .001). Treatment-emergent adverse events occurred in 34 participants (21.8%) and 40 participants (25.6%) in the perfluorohexyloctane and control groups, respectively. Conclusions and Relevance: Results of this randomized clinical trial demonstrate that perfluorohexyloctane eye drops significantly ameliorated the signs and symptoms of DED associated with MGD with a rapid efficacy as well as satisfactory tolerability and safety through 57 days. Findings support the use of these eye drops if results can be confirmed independently and over longer time periods. Trial Registration: ClinicalTrials.gov Identifier: NCT05515471.

Topical review of the relationship between contact lens wear and meibomian gland dysfunction.

Contact lens (CL) wearers often suffer from ocular discomfort, which leads to cessation of CL wear. About 30% to 50% of CL wearers complain of dry eye (DE) symptoms. Meibomian gland dysfunction (MGD) is considered the most common cause of evaporative DE. Numerous studies have investigated whether CL wear might affect the meibomian glands. This manuscript reviews studies examining the relationship between CL use and MGD. A PubMed database search was conducted for studies published between 1980-2021 with one or a combination of search terms related to "meibomian gland", "meibomian gland dysfunction", "contact lens", and/or "dry eye". Of the 115 papers reviewed, 22 articles were identified that examined the association between CL and MGD. Fifteen showed that CL wear affects the morphology and function of meibomian glands (MGs), while seven reported no significant impact of CL wear on MGs. This review provides an overview of these studies, emphasizing the diagnostic tests of MGD and conclusions. The review highlights the need for longitudinal prospective large cohort studies with control non- CL wearers to clarify the ambiguous relationship between MGD and CL wear, with special attention to varying CL material and wear times in order to identify the long-term impact of CLs on MG.

Antibiotic treatment for dry eye disease related to meibomian gland dysfunction and blepharitis - A review.

BACKGROUND: Dry eye disease (DED) is among the most prevalent ophthalmic conditions but is often underdiagnosed and mistreated. Antibiotics are regularly used to treat DED caused by meibomian gland dysfunction (MGD) or blepharitis, but their use has been questioned. OBJECTIVE: To critically evaluate the use of oral and topical antibiotics in DED management. METHODS: A literature search was conducted on November 15th, 2021, in the PubMed database. The search terms were: (antibiotics OR azithromycin OR doxycycline OR minocycline) AND (dry eye disease OR meibomian gland OR blepharitis anterior OR blepharitis posterior OR chronic blepharitis). All relevant original articles with English full-text were included. Case reports and review articles were excluded. RESULTS: The search provided 619 articles, of which 22 met the inclusion criteria. Oral and topical antibiotics appeared to have short-term positive effects on signs and symptoms of blepharitis- or MGD-related DED. However, these improvements often reverted upon cessation of treatment. The need for repeated treatments and mild adverse events were common. CONCLUSIONS: Current evidence suggests that patients with blepharitis- or MGD-related DED experience short-term benefits of antibiotics. However, evidence for lasting improvement after completed treatment was lacking. Given the unclear long-term benefits, common side effects, and increasing antibiotic resistance seen globally, the existing literature is not sufficient to conclude that antibiotics are useful in long-term MGD management. A survival-analysis of a single round of antibiotics, in addition to the effects of repeated rounds of treatment, on DED parameters could provide useful insights.

Prevalence and Incidence of Dry Eye and Meibomian Gland Dysfunction in the United States: A Systematic Review and Meta-analysis.

Importance: Dry eye is a common clinical manifestation, a leading cause of eye clinic visits, and a significant societal and personal economic burden in the United States. Meibomian gland dysfunction (MGD) is a major cause of evaporative dry eye. Objective: To conduct a systematic review and meta-analysis to obtain updated estimates of the prevalence and incidence of dry eye and MGD in the United States. Data Sources: Ovid MEDLINE and Embase. Study Selection: A search conducted on August 16, 2021, identified studies published between January 1, 2010, and August 16, 2021, with no restrictions regarding participant age or language of publication. Case reports, case series, case-control studies, and interventional studies were excluded. Data Extraction and Synthesis: The conduct of review followed a protocol registered on PROSPERO (CRD42021256934). PRISMA guidelines were followed for reporting. Joanna Briggs Institute and Newcastle Ottawa Scale tools were used to assess risk of bias. Data extraction was conducted by 1 reviewer and verified by another for accuracy. Prevalence of dry eye and MGD were combined in separate meta-analyses using random-effects models. Main Outcomes and Measures: Prevalence and incidence of dry eye and MGD in the United States. Summary estimates from meta-analysis of dry eye and MGD prevalence with 95% CI and 95% prediction intervals (95% PI). Results: Thirteen studies were included in the systematic review. Dry eye prevalence was reported by 10 studies, dry eye incidence by 2 studies, and MGD prevalence by 3 studies. Meta-analysis estimated a dry eye prevalence of 8.1% (95% CI, 4.9%-13.1%; 95% PI, 0%-98.9%; 3 studies; 9 808 758 participants) and MGD prevalence of 21.2% (95% CI, 7.2%-48.3%; 95% PI, 0%-100%; 3 studies; 19 648 participants). Dry eye incidence was 3.5% in a population 18 years and older and 7.8% in a population aged 68 years and older. No studies reported MGD incidence. Conclusions and Relevance: This systematic review and meta-analysis demonstrated uncertainty about the prevalence and incidence of dry eye and MGD in the United States. Population-based epidemiological studies that use consistent and validated definitions of dry eye and MGD are needed for higher-certainty estimates of dry eye and MGD prevalence and incidence in the United States.

Effect of Intense Pulsed Light Therapy in Dry Eye Disease Caused by Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis.

BACKGROUND: This study aimed to systematically evaluate the effect of intense pulsed light (IPL) therapy in patients harboring dry eye disease caused by meibomian gland dysfunction (MGD) based on qualified studies. METHODS: The electronic databases, including PubMed, Cochrane, and Embase, were searched using keywords to identify available publications updated to November 2021. Relative risk or weighted mean difference combined with 95% confidence interval was used to synthesize the outcomes of included studies. The meta-analysis included 15 randomized controlled trials with 1,142 patients (2,284 eyes). RESULTS: The results revealed that IPL could significantly decrease the ocular surface disease index (OSDI), standard patient evaluation of eye dryness (SPEED), artificial tear usage, tear film lipid layer, meibomian gland quality (MGQ), meibomian gland expression (MGX), and corneal fluorescein staining (CFS) while increase tear break-up time (TBUT) and noninvasive tear break-up time (NIBUT) compared with sham. Compared with MGX, IPL+MGX markedly decreased the SPEED, CFS, and tear meniscus height (TMH), but with increased TBUT. Compared with MGX, IPL showed significant effect in increasing the OSDI and TBUT, but decreasing the TMH and NIBUT. However, no significant differences were seen between IP+MGX and MGX in OSDI, MGQ, and MGX, nor between IPL and MGX in OSDI, SPEED, and TBUT. CONCLUSION: We identified that the application of IPL alone or IPL combined with MGX elicited superior clinical effect for improving the eye function and symptoms in the treatment of MGD-related dry eye disease, which is considered available for wide clinical application.

Comparison of the clinical effects of two different doses (0. 05% and 0. 1%) of topical cyclosporine A in dry eyes with meibomian gland dysfunction / Comparação de efeitos clínicos de duas doses diferentes (0, 05% e 0, 1%) de ciclosporina A tópica em olhos secos com disfunção da glândula tarsal

ABSTRACT Objective: To compare the clinical efficacy of two different doses of topical cyclosporine A used in addition to artificial tears in the treatment of patients with meibomian dysfunction and secondary dry eye. Methods: Fifty patients aged 18 to 40 years, who presented to our clinic between June 2020 and June 2021 were included in our study. Patients were divided into two groups as Group A (topical cyclosporine A 0.05%) and Group B (topical cyclosporine A 0.1%). All the patients underwent a detailed ophthalmological examination, basal Ocular Surface Disease Index measurement, and Schirmer 1 and tear break-up time tests at all visits. Results: The mean age was 32±7.1 years in Group A and 30.7±8.5 years in Group B. In Group A, there were 15 women and ten men, and Group B consisted of 14 women and 11 men. There was no difference between the groups in terms of age and gender distribution (p>0.05). Schirmer 1 and tear break-up time results and Ocular Surface Disease Index score also did not significantly differ between the groups (p>0.05). Conclusion: Cyclosporine A 0.05% and 0.1% eye drops were both seen to be effective in managing dry eye disease in patients with meibomian gland dysfunction.

RESUMO Objetivo: Comparar a eficácia clínica de duas doses diferentes de ciclosporina A tópica utilizada além da lágrima artificial no tratamento de pacientes com disfunção da glândula tarsal e olho seco secundário. Métodos: No estudo, foram incluídos 50 pacientes com idades entre 18 e 40 anos, que se apresentaram em nossa clínica entre junho de 2020 e junho de 2021. Os pacientes foram divididos em dois grupos: Grupo A (ciclosporina A 0,05% tópica) e Grupo B (ciclosporina A 0,1% tópica). Todos os pacientes foram submetidos a um exame oftalmológico detalhado, medição basal do Índice de Doença da Superfície Ocular, e testes de Schirmer 1 e de tempo de ruptura em todas as visitas. Resultados: A idade média foi de 32±7,1 anos no Grupo A e 30,7±8,5 anos no Grupo B. No Grupo A, havia 15 mulheres e dez homens, e o Grupo B consistia de 14 mulheres e 11 homens. Não havia diferença significativa entre os grupos em termos de distribuição por idade e gênero (p>0,05). Os resultados do Schirmer 1 e do tempo de ruptura e do Índice de Doenças da Superfície Ocular também não apresentaram diferença significativa entre os grupos (p>0,05). Conclusão: Observou-se que os colírios de ciclosporina A 0,05% e 0,1% são eficazes no tratamento da síndrome do olho seco em pacientes com disfunção da glândula tarsal.

Rete Ridges in Eyelid Margin and Inflammatory Cytokines in Meibomian Gland Dysfunction Associated with Dry Eye Symptom.

PURPOSE: To evaluate the morphology and function of rete ridges in eyelid margin and inflammatory cytokines in meibomian gland dysfunction (MGD) associated with dry eye symptom. METHODS: A total of 63 subjects with OSDI score ≥13 were enrolled in MGD group and no-MGD group. Main measurements included tear cytokines levels and the rete ridges morphology. RESULTS: Meibomian gland loss (MGL), corneal staining score (CSS), and IL-6 and TNF-α increased, meibomian gland secretion (MGS) decreased, the density of the rete ridges was lower, the longest diameters and shortest diameters of the rete ridges were longer in MGD group. The MGD group showed a negative correlation between MGL and BUT and MGS, but it showed a positive correlation with CSS. CSS was negatively correlated with IL-6. LLT was negatively correlated with IL-2 and IL-4. The shortest diameters of rete ridges in eyelid margin had a significant positive correlation with IL-2, IL-4, IL-10, and IFN-γ levels. CONCLUSION: Change of meibomian gland function and the rete ridges morphology might have some correlation with the injury to ocular surface. Some inflammatory cytokines were correlated with the change of the rete ridges morphology, which might in turn affect the ocular surface function.

The Effect of Therapeutic Meibomian Glands Expression on Evaporative Dry Eye: A Prospective Randomized Controlled Trial.

PURPOSE: To determine the clinical benefits of Meibomian gland expression therapy for the treatment of dry-eye disease caused by Meibomian gland dysfunction (MGD). METHODS: In a prospective randomized controlled double-masked trial, 87 eyes of 44 patients with MGD and dry-eye symptoms were enrolled. Patients were randomly assigned into two groups; a study group that received therapeutic Meibomian gland expression once every month, and a control group that received sham treatment. All patients received treatment with artificial tears. RESULTS: One week after the first treatment, the Ocular Surface Disease Index (OSDI) score improved significantly in the study group (mean change -18.5 ± 21.2, p = .01) but not in the control group (-3.8 ± 15.8, p = .16); after 1 month, both groups improved significantly (-20.5 ± 19 p = .001 in the study group and -6.5 ± 11, p = .016 in the control group). The improvement continued at 2 months in the study group (-28.4 ± 26.1, P < .0001) and in the control group (-9.6 ± 9.9, p = .007). The blepharitis questionnaire score improved in the study group compared to controls after 1 week (-9.95 ± 12.52 versus -1.77 ± 9.1, p = .03) 1 month (-11.5 ± 10.9 versus -1.1 ± 9.4, p = .02) and 2 months (-16.5 ± 8.0 versus -8.8 ± 11.7, p = .02). Burning sensation was significantly reduced only in the study group. Mean change after 2-month treatment was -2.00 ± 1.2583 (p < .0001) vs -0.67 ± 1.44 (p = .08). The trend was similar in Eyelid scales. Conjunctival hyperemia improved only in the study group 1 week after the treatment (-0.12 ± 0.32 p = .03). CONCLUSION: Therapeutic Meibomian gland expression improves dry-eye symptoms in subjects with MGD, compared to conventional treatment with artificial tears.

Evaluation of Ocular Surface and Meibomian Glands in Patients With Scleroderma.

PURPOSE: To evaluate the prevalence of dry eye and meibomian gland dysfunction in patients with scleroderma. METHODS: A total of 32 patients with scleroderma (study group) and 31 healthy subjects (control group) were enrolled. Besides routine ophthalmologic evaluation, Schirmer 1 test, tear break-up time, tear osmolarity, ocular surface staining with fluorescein (Oxford score), and Ocular Surface Disease Index (OSDI) score, meibomian gland dysfunction evaluation (foamy tears, telangiectasia of the eyelid, eyelid contour abnormalities, and meibomian plugs), and meibography were performed. RESULTS: Sixty-four eyes of 32 patients with scleroderma and 62 eyes of 31 healthy individuals were evaluated. Mean ages of the study group was 48.34 ± 9.73 years (21-62 years) and of the control group was 45.84 ± 4.42 years (38-54 years) (P = 0.067). Mean duration of systemic sclerosis or scleroderma in study group was 9.78 ± 7.40 years (1-30 years). Mean tear break-up time was shorter in study group than that in the control group (P < 0.0005). No statistical differences were detected for osmolarity, OSDI score, and Schirmer 1 values between groups (P = 0.051, P = 0.053, and P = 0.358, respectively). The prevalence of grade 1 and higher Oxford score was higher in the study group (P < 0.0005). Upper meiboscores of grade 1 and higher were found to be more common in the study group than those in the control group (P = 0.036). The presence of foamy tears and telangiectasia of the eyelids were significantly higher in the study group (P = 0.002 and P = 0.002, respectively). OSDI score was the only significantly correlated data with disease duration (Spearman ρ coefficient = 0.396, P = 0.001). CONCLUSIONS: Evaporative type dry eye is more common in patients with scleroderma than the healthy population.

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

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 8J/cm2 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 (<40y, 40-60y, and >60y) 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.

A Randomized Clinical Study (SEECASE) to Assess Efficacy, Safety, and Tolerability of NOV03 for Treatment of Dry Eye Disease.

PURPOSE: NOV03 has a unique dual mode of action to address dry eye disease (DED) associated with meibomian gland dysfunction. SEECASE evaluated the efficacy, safety, and tolerability of NOV03 at 2 dosing regimens compared with a saline comparator in patients with DED. METHODS: SEECASE was a prospective, multicenter, randomized, double-masked, saline-controlled clinical study. A total of 336 DED patients [tear film breakup time ≤5 seconds, abnormal meibum secretion, total corneal fluorescein staining (tCFS) score of 4 ≤ X ≤ 11 (National Eye Institute scale), Schirmer of ≥5 mm] were randomized in a 2:2:1:1 manner to NOV03 4 times daily (QID), NOV03 twice daily (BID), saline BID, and saline QID, respectively. The primary efficacy endpoint was tCFS staining at 8 weeks for both regimens. Secondary endpoints included visual analog scales and the Ocular Surface Disease Index questionnaire for symptom assessment. RESULTS: The study met its primary endpoint, change from baseline of tCFS over control, for both dosing regimens QID and BID (P < 0.001 and P = 0.009, respectively). NOV03 also showed pronounced improvement in various symptoms. For the Eye Dryness Score, changes from baseline were statistically significant compared with those of the control at week 8 [P < 0.001 (QID) and P = 0.002 (BID)]. Benefits on tCFS and symptoms started at 2 weeks after start of treatment and were maintained over the study duration. The effects were dosing schedule dependent. NOV03 was well tolerated with instillation site reactions below 3% in both treatment regimes. CONCLUSIONS: The SEECASE study demonstrated that NOV03 improves signs and symptoms in patients with highly symptomatic evaporative dry eye disease.

Subjective Quality of Vision in Evaporative Dry Eye Patients After Intense Pulsed Light.

Background and objective: Intense pulsed light (IPL) improves visual and clinical symptoms of dry eye disease and helps improve meibomian gland (MG) function thereby positively contributing to the tear lipid layer, a major component for a normal tear film physiology. The objective of this study was to assess the effectiveness of IPL in moderate to severe evaporative dry eye (DE) owing to meibomian gland dysfunction (MGD) on the subjective quality of vision (QOV). Methods: This is a prospective, open-label study; patients with moderate to severe evaporative DE owing to MGD were consecutively enrolled and underwent two IPL treatment sessions at 3-week intervals. Clinical assessments included: Ocular Surface Disease Index (OSDI) and QOV questionnaires, noninvasive tear breakup time (NITBUT), interferometric fringe pattern as determined by tear film lipid layer (TFLL) quality, lid margin abnormalities, corneal fluorescein staining (CFS), conjunctival hyperemia (CH) redness score, MG (evaluated with a slit-lamp microscope), best-corrected visual acuity, endothelial cell count, and intraocular pressure were conducted at pretreatment, days 21 and 42 after IPL treatment. Results: A total of 128 eyes of 64 patients (39 women, 25 men; mean age 36.09 ± 11.13 years) with moderate to severe DE owing to MGD consecutively received IPL treatment at days 1 and 21. OSDI (p < 0.05), QOV (p < 0.05), NITBUT (p < 0.05), TFLL score (p < 0.05), and MG quality and expressibility (p < 0.05) improved significantly at day 42, whereas CFS and CH showed minor not significant improvements (p > 0.05) at day 42 of assessment. Conclusions: IPL treatment reduced the severity of DE symptoms and improved the overall tear film stability in patients with moderate to severe evaporative DE owing to MGD. In addition, visual complaints experienced by DE patients secondary to MGD significantly decreased.

Preliminary Assessment of Intense Pulsed Light Treatment on the Upper Eyelids for Meibomian Gland Dysfunction.

Objective: To conduct a preliminary assessment of the intense pulsed light (IPL) treatment on the upper eyelid. Background: IPL therapy is an effective therapy for meibomian gland dysfunction (MGD). The normal treatment region includes the skin below the lower eyelids and both temporal parts, but not the upper eyelid. Methods: Thirty patients with mid-to-severe dry eye disease caused by MGD were selected and randomly divided into two groups. Fifteen controls in group A received normal IPL treatment. Fifteen patients in Group B underwent additional IPL treatment on the upper eyelid. The change in noninvasive tear breakup time (BUT), Ocular Surface Disease Index (OSDI) questionnaire, patient satisfaction, and adverse events were measured and recorded at each visit, before each treatment. Results: The dry eye symptoms of the patients in both groups improved. The patients in group B had better recovery than those in group A: BUT (right eye: 11.6 ± 3.67 sec vs. 7.73 ± 1.99 sec; left eye: 12.73 ± 4.19 sec vs. 7.73 ± 1.40 sec), OSDI (8.87 ± 4.31 vs. 14.93 ± 3.47); patient satisfaction in group B remained good, but decreased in group A with prolonged treatment duration. No serious skin and eye complications were found in any patient. Conclusions: This study showed the patients who received IPL treatment on the upper eyelid experienced improved symptoms of MGD. A further long-term study should be conducted to increase our understanding of the effect of expanded IPL treatment.

Evaluation of the efficacy of optimal pulsed technology treatment in patients with cataract and Meibomian gland dysfunction in the perioperative period.

BACKGROUND: The aim of this study was to evaluate the efficacy and safety of M22 Optimal Pulsed Technology (OPT) applied in patients with age-related cataract and Meibomian gland dysfunction (MGD) in perioperative period. METHODS: This prospective observational study was carried out in the Jinan Mingshui Eye Hospital (Zhangqiu, China). We studied 60 patients (30 in the OPT treatment group and 30 in the conventional surgery group) with age-related cataract and MGD who underwent phacoemulsification and evaluated the efficacy of OPT treatment before and 1 month and 3 months after surgery. Ocular Surface Disease Index (OSDI) questionnaire, biomicroscopic examination of lid margins, Meibomian gland yielding secretion score (MGYSS), corneal fluorescein staining scores (CFS), tear film break-up time (TBUT), tear meniscus height (TMH) and the morphology of the MG (meibography) followed by Keratograph 5 M (K5M) were used to assess the patients' conditions. RESULTS: There were significant differences in the scores of OSDI, MGYSS, TBUT, and CFS between the preoperative and postoperative outcomes (p < 0.05). In the OPT treatment group, the postoperative ocular surface condition was obviously better and the patient satisfaction rate was higher than those before surgery. There were significant differences in the scores of OSDI, EMAS, MGYSS and CFS before and 1 month after surgery (p < 0.05). In addition, there were also significant differences in the scores of OSDI, EMAS, MGYSS and MGLS before and 3 months after surgery (p < 0.05). No complications appeared during OPT treatment. CONCLUSIONS: Cataract surgery can aggravate MGD and is detrimental to ocular surface health. OPT treatment was a safe and effective intervention for patients with MGD and cataract during perioperative period.

Intense pulsed light (IPL) therapy for the treatment of meibomian gland dysfunction.

BACKGROUND: Meibomian gland dysfunction (MGD) is the major cause of evaporative dry eye disease, which is the more prevalent form of dry eye disease. Intense pulsed light (IPL) therapy, involving treatment of the skin near the eyelids, has emerged as a potential treatment for MGD. OBJECTIVES: To evaluate the effectiveness and safety of intense pulsed light (IPL) for the management dry eye disease resulting from meibomian gland dysfunction (MGD). SEARCH METHODS: We searched CENTRAL, MEDLINE (Ovid), Embase Ovid and three trial registers for eligible clinical trials on 1 August 2019. There were no restrictions on publication status, date or language. SELECTION CRITERIA: We included randomised controlled trials (RCTs) studying the effectiveness or safety of IPL for treating MGD. DATA COLLECTION AND ANALYSIS: Our outcomes of interest were the change from baseline in subjective dry eye symptoms, adverse events, changes to lipid layer thickness, tear break-up time (TBUT), tear osmolarity, eyelid irregularity, eyelid telangiectasia, meibomian gland orifice plugging, meibomian gland dropout, corneal sodium fluorescein staining and conjunctival lissamine green staining. Two review authors independently screened abstracts and full-text articles, extracted data from eligible RCTs and judged the risk of bias using the Cochrane tool. We reached consensus on any disagreements by discussion. We summarised the overall certainty of the evidence using the GRADE Working Group approach. MAIN RESULTS: We included three RCTs, one from New Zealand, one from Japan and one from China, published between 2015 and 2019. Together, these trials enrolled 114 adults (228 eyes). Two studies used a paired-eye (inter-eye comparison) design to evaluate the effects of a sham (control) IPL treatment relative to an actual IPL treatment. One study randomised individuals to either an IPL intervention combined with meibomian gland expression (MGX), or MGX alone (standard therapy). The study follow-up periods ranged from 45 days to nine months. None of the trials were at low risk of bias in all seven domains. The first authors of two included studies were in receipt of funding from patents or the manufacturers of IPL devices. The funding sources and declaration of interests were not given in the report of the third included trial. All three trials evaluated the effect of IPL on dry eye symptoms, quantified using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. Pooling data from two trials that used a paired-eye design, the summary estimate for these studies indicated little to no reduction in dry eye symptoms with IPL relative to a sham intervention (mean difference (MD) -0.33 units, 95% confidence interval (CI) -2.56 to 1.89; I² = 0%; 2 studies, 144 eyes). The other study was not pooled as it had a unit-of-analysis error, but reported a reduction in symptoms in favour of IPL (MD -4.60, 95% CI -6.72 to -2.48; 84 eyes). The body of evidence for this outcome was of very low certainty, so we are uncertain about the effect of IPL on dry eye symptoms. There were no relevant combinable data for any of the other secondary outcomes, thus the effect of IPL on clinical parameters relevant to dry eye disease are currently unclear. For sodium fluorescein TBUT, two studies indicated that there may be an improvement in favour of IPL (MD 2.02 seconds, 95% CI 0.87 to 3.17; MD 2.40 seconds, 95% CI 2.27 to 2.53; 172 eyes total; low-certainty evidence). We are uncertain of the effect of IPL on non-invasive tear break-up time (MD 5.51 seconds, 95% CI 0.79 to 10.23; MD 3.20, 95% CI 3.09 to 3.31 seconds; two studies; 140 eyes total; very low-certainty evidence). For tear osmolarity, one study indicated that there may be an improvement in favour of IPL (MD -7.00 mOsmol/L, 95% -12.97 to -1.03; 56 eyes; low-certainty evidence). We are uncertain of the effect of IPL on meibomian gland orifice plugging (MD -1.20 clinical units, 95% CI -1.24 to -1.16; 84 eyes; very low-certainty evidence). We are uncertain of the effect of IPL on corneal sodium fluorescein staining. One study reported no evidence of a difference between the IPL and sham intervention arms at three months of follow-up (P = 0.409), and a second study reported data favouring IPL (MD -1.00 units, 95% CI -1.07 to -0.93 units; 172 eyes in total; very low-certainty evidence). We considered the incidence of adverse events at the study endpoint, as a measure of safety. As most trials did not specifically report adverse events, the safety of IPL as a treatment for MGD could also not be determined with any certainty. Very low-certainty results from individual studies suggest some adverse effects that may be experienced by participants, include mild pain and burning, and the potential for partially losing eyelashes (due to clinician error). AUTHORS' CONCLUSIONS: This systematic review finds a scarcity of RCT evidence relating to the effectiveness and safety of IPL as a treatment for MGD. Whether IPL is of value for modifying the symptoms or signs of evaporative dry eye disease is currently uncertain. Due to a lack of comprehensive reporting of adverse events, the safety profile of IPL in this patient population is also unclear. The current limitations in the evidence base should be considered by clinicians using this intervention to treat MGD, and outlined to individuals potentially undergoing this procedure with the intent of treating dry eye disease. The results of the 14 RCTs currently in progress will be of major importance for establishing a more definitive answer regarding the effectiveness and safety of IPL for treating MGD. We intend to update this review when results from these trials become available.

Intense pulse light therapy treatment for refractory dry eye disease due to meibomian gland dysfunction.

PURPOSE: To assess the effect of the intense pulse light (IPL) therapy for the treatment of meibomian gland dysfunction (MGD) and dry eye parameters. METHODS: Patients who underwent an IPL therapy for the treatment of MGD were included in this retrospective study. Ocular Surface Disease Index (OSDI) scores, the frequency of daily lubricant use, non-invasive tear break-up time (NIBUT), meibomian glad dropout scores, corneal staining scores, and Schirmer test results were collected from patient charts that recorded at baseline and follow-up visits at 1 month, 3 months, and 12 months. For the analysis, patients were grouped based on the severity of their baseline meibomian gland dropout score as mild, moderate, and severe atrophy. RESULTS: Forty-three patients (mild atrophy = 22, moderate atrophy = 17, and severe atrophy = 4) were included for analysis. Except for the Schirmer test, all dry eye parameters significantly improved in patients with mild and moderate atrophy following the treatment and this effect lasted until the 12-month follow-up visit (p < 0.001). No significant improvement in any parameter was observed in patients with severe atrophy at any time point (p > 0.05). In the mild and moderate atrophy groups, OSDI scores, as well as NIBUT, started improving at 1 month (p < 0.01), while corneal staining and meibomian gland dropout scores showed earliest improvements at 3 months (p < 0.01). No adverse events were observed, except for temporary redness in 4 patients. CONCLUSION: The IPL treatment seems an effective and safe treatment for patients with MGD. This study shows that the IPL resulting in an earlier improvement in symptoms and signs with long-lasting beneficial effect on the meibomian glands.