Efficacy Evaluation Of A Thermodynamic Treatment System For Meibomian Gland Dysfunction

Objective:To evaluate the safety and clinical efficacy of a Thermal Pulsation System for patients with meibomian gland dysfunction compared with the traditional warm compress.And on this basis to explore the correlation between the tear film lipid layer thickness and the signs related to meibomian gland dysfunction.Methods:This is a prospective,randomized and controlled clinical trial.1.Patients who met the following criteria were eligible for the study.Fifty patients(100 eyes)with MGD were enrolled from Tianjin,Medical University Eye Hosptical between September,2015 and September,2016.Inclusion criteria:(1)Aged over 18,regardless of gender or any race;(2)Reported dry eye symptoms with a standard patient evaluation for eye dryness(SPEED)score greater than 6 at the baseline;(3)Both eyes were MGD.the secretion score of either eye lower than 12 by evaluating 15 meibomian glands of the lower eyelid.(4)Willing to cooperate with test procedures and do the warm compress at home if assigned to the control group;(5)Ability to complete an initial evaluation and the follow-up visits after treatment.Exclusion criteria:(1)Reported dry eye symptoms with a standard patient evaluation for eye dryness(SPEED)score greater than 15 at the baseline;(2)Ocular inflammation,or active infection in either eye;(3)Ocular trauma,surgery or abnormalities of ocular surface function that may affect the integrity of cornea in either eye within three months of the baseline examination;(4)Abnormalities of eyelid function in either eye.(5)Being determined to have dry eye symptoms that were not secondary to MGD,such as a systemic autoimmune disease,and not willing to stop to use the systemic drug which can lead to dry eye during the study period;(6)Treatment with lacrimal plugs or canaliculoplasty in either eye within three months of the baseline examination or the potential of requiring new treatment during the follow-up period(7)Involvement in medical clinical trials within 30 days of the baseline examination.2.Grouping and follow-up: Fifty patients were randomly divided into two groups: group A and group B.Patients in group A received a 12-minutes Lipiflow? thermodynamic system treatment.Patients in group B received warm compress using the Eye Giene? Insta-Warmth TM patch(American Eyedetec Medical,Inc.)for 15 minutes once a day for two weeks.The following clinical tests were performed at each follow-up visit in this order: dry eye questionnaire,uncorrected visual acuity(UCVA),noncontact intraocular pressure examination,lipid layer thickness(LLT)and partial blink ratio(PB)examination,meibomian gland dropout,break-up time(BUT),corneal Fluorescein staining(CFS),Schirmer I test(SIT),and meibomian gland openings evaluation and meibomian gland secretion examination before and after treatment for 1month,2months,3months.3.Statistical Analysis:Data analysis was performed using SPSS for Windows(version 17.0,SPSS Inc.).The measurement data were indicated by(?x± s)and the counting data were compared with the chi-square test.A repeated measures analysis of variance(ANOVA)test was performed for comparison of test group and control group at all time points.To compare the baseline and posttreatment outcomes,paired two-tailed t-test was used.To compare the outcomes for two groups at the same time,the independent sample t test was used.All confidence intervals is set to 95%,using in all cases the same level of significance(P<0.05).Results:1.There were no difference between two groups in gender,age,SPEED scores,UCVA,IOP,LLT,PB,meibomian gland dropout,SIT,BUT,CFS scores,meibomian gland openings and meibomian gland secretion scores before the treatment(P > 0.05).During the study period,there was no any adverse events.2.One month after treatment,symptoms and all signs except meibomian gland dropout of two groups have improved.There were no difference between two groups in SPEED scores,LLT,PB,meibomian gland dropout,BUT,SIT,meibomian gland openings,meibomian gland secretion scores(P > 0.05);The CFS scores were obviously lower than those of the group A(P<0.01).3.Two months after treatment,there were no difference between two groups in LLT,PB,meibomian gland dropout,SIT,CFS scores(P > 0.05);The BUT,meibomian gland openings and meibomian gland secretion scores of group A were obviously better than those of the group B(P<0.01).4.Three months after treatment,the SPEED scores,BUT and CFS scores have obviously improved than the baseline of two groups(p<0.01).There was no significant change in the meibomian gland dropout(P>0.05).There were alsoobviously improvement in LLT,PB,meibomian gland openings and meibomian gland secretion scores in group A when comparing the three-month visit data to baseline visit data(P<0.01).There were improvement in LLT,PB,meibomian gland openings and meibomian gland secretion scores in group B,but the difference between baseline and three-month visits was not statistically significant(P>0.05).There were no difference in PB,SIT,CFS scores between two groups.The LLT,BUT,meibomian gland openings and meibomian gland secretion scores of group A were obviously better than those of the group B(P<0.01).5.The UCVA and IOP had no obviously change comparing the data after treatment data with the baseline(P>0.05).6.The lipid layer thickness was found to positively correlate with BUT,meibomian gland openings,meibomian gland secretion scores(P>0.05).Conclusions:1.The thermodynamic treatment system is safe for the treatment of MGD.During 3-months study period,cornea and the ocular surface damage were not found.Security indicators such as UCVA and IOP had no obvious change.2.The thermodynamic treatment system is effective for the treatment of MGD.It is effective for improving dry eye symptoms,BUT,lipid layer thickness,PB,meibomian gland openings,meibomian gland secretion and ocular surface condition during 3-months follow-up.It results in better effect than warm compress.Meanwhile we find the curative effect of the thermodynamic treatment system was possible for some time.conversely,warm compress was also effective for treatment of MGD,but there was shorter duration more likely to relapse.3.The thermodynamic treatment system can effectively improve dry eye symptoms and signs of patients with MGD,but in the short term it does not improve the meibomian gland atrophy.4.The lipid layer thickness measured by Lipiview? ocular surface interferometer was always found to positively correlate with BUT,meibomian gland openings,meibomian gland secretion scores.Lipiview ? ocular surface interferometer can play a supporting and guiding role to diagnosis of MGD.