Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction

Overview

Dry eye syndrome is a common eye disease that affects 1 to 2 out of 10 persons around the planet. One common cause of this disease is the meibomian gland dysfunction. Meibomian glands are very small glands located at the rim of the eyelids that produce an oily substance that prevents the evaporation of tears. When these glands are compromised, the tear film evaporates quickly and the eyes dry up. This disease presents as eye irritation, foreign body sensation, inflammation, etc. The treatment of choice for MGD is eyelid massage and warm compresses 2 times a day. However, these treatments not always work perfectly, and as a result, patients find it hard to follow doctor's orders. Another kind of treatment is thermal therapy. There are several devices that are designed to apply heat on the eyelids, such as Lipiflow, MiBo Thermoflo, and Blephasteam. In this study, we want to find out whether thermal therapy with MiBo Thermoflo works better than warm compresses and eyelid massage use in the treatment of dry eye caused by MGD. To do this, we will select several patients and will assign them randomly to either the group with thermal therapy with MiBo Thermoflo or to the group with warm compresses and eyelid massage. The Mibo group will receive 3 sessions of thermal therapy at 2 weeks interval and the control group warm compresses and eyelid massage 2 times per day. All subjects will have a follow up of 24 weeks and we will compare results for both groups at the end of the study.

Detailed description

Dry eye syndrome is considered one of the most important ophthalmologic diseases, affecting 10 to 20% of the general population. Of these, 3.7% to 70% of cases are due to meibomian gland dysfunction (MGD). MGD is a chronic diffuse disease characterized by terminal duct obstruction and/or qualitative/quantitative changes in gland secretion. This causes a disruption in the tear film, ocular irritation symptom, inflammation, and ocular surface symptoms. The gold standard for the treatment of meibomian dysfunction is the use of warm compresses and eyelid massage 2 times a day. These have variable results and consequently patient's adherence to treatment is low. An alternative treatment is the use of thermal therapy devices such as Lipiflow, MiBo Thermoflo, and Blephasteam. The objective of this study is to determine if the thermal device MiBo Thermoflo is more effective than warm compresses and eyelid massage in the treatment of dry eye secondary to MGD. Participants will be randomly assigned to one of two groups: the Mibo group will receive 3 sessions of thermal therapy at 2 weeks interval and the control group warm compresses and eyelid massage 2 times per day. All subjects will have follow up of 24 weeks and we will compare results for both groups at the end of the study. During the protocol patients in both groups will continue with their standard treatment for dry eye as needed.

Interventions

• Device Mibo Thermoflo
  Thermal therapy with Mibo Thermoflo for 11 minutes per eye, during each session.
• Other Warm compresses and eyelid massage
  Warm compresses plus eyelid massage 2 times per day 11 minutes per eye.

Primary outcome measures

• Meibomian gland expressibility [Time frame: Basal to 24 weeks]
• Meibum quality [Time frame: Basal to 24 weeks]
• Corneal and conjunctival staining with fluorescein dye [Time frame: Basal to 24 weeks]
• Corneal and conjunctival staining with lissamine green dye [Time frame: Basal to 24 weeks]
• Tear Break-up Time (TBUT) [Time frame: Basal to 24 weeks]
• Schirmer test with and without anesthesia [Time frame: Basal to 24 weeks]
• Symptom Assessment in Dry Eye questionnaire (SANDE) [Time frame: Basal to 24 weeks]
• Ocular Surface Disease Index (OSDI) [Time frame: Basal to 24 weeks]
• Dry Eye Questionnaire 5 (DEQ-5) [Time frame: Basal to 24 weeks]
• Tear osmolarity [Time frame: Basal to 24 weeks]

Secondary outcome measures (10)

• Short term changes with corneal and conjunctival staining with fluorescein dye [Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4]
• Short term changes with corneal and conjunctival staining with lissamine green dye [Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4]
• Short term changes in tear stability [Time frame: These parameterd will be evaluated before sessions of termal therapy at week 2 and week 4]
• Short term changes in Symptom Assessment in Dry Eye questionnaire (SANDE) [Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4]
• Short term changes in Ocular Surface Disease Index (OSDI) [Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4]
• Short term changes in Dry Eye Questionnaire 5 (DEQ-5) [Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4]
• Eyelid skin temperature [Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4]
• Corneal conjunctival temperature [Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4]
• Bulbar conjunctival temperature [Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4]
• Tarsal conjunctival temperature [Time frame: These parameters will be evaluated before sessions of thermal therapy at week 2 and week 4.]

Eligibility criteria

Inclusion criteria

• Patients diagnosed with:

• Dry eye syndrome with meibomian gland dysfunction alone or in combination of other type of dry eye.
• Patients who were previously treated with eyelid massages and warm compresses without any improvement.

Exclusion criteria

• Pregnant women.
• History of ocular surgery within three months prior to inclusion.
• History of trauma, infection or inflammation within three months prior to inclusion.
• Contact lens use in the last week before inclusion.
• Patients with active ocular allergic disease.
• Patient with microbial keratitis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Mexico · 1 center

• Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey

Publications

• Arita R, Morishige N, Shirakawa R, Sato Y, Amano S. Effects of Eyelid Warming Devices on Tear Film Parameters in Normal Subjects and Patients with Meibomian Gland Dysfunction. Ocul Surf. 2015 Oct;13(4):321-30. doi: 10.1016/j.jtos.2015.04.005. Epub 2015 May 30. PMID 26031204
• Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20. PMID 28736335
• Foulks, G. N., Lemp, M., Jester, J., Sutphin, J., Murube, J., & Novack, G. (2007). report of the international dry eye workshop (DEWS). Ocul Surf, 5(2), 65-204. Foulks, G. N., Lemp, M., Jester, J., Sutphin, J., Murube, J., & Novack, G. (2007). Report of the international dry eye workshop (DEWS). Ocul Surf, 5(2), 65-204.
• Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available. PMID 21450919
• Hom M, De Land P. Prevalence and severity of symptomatic dry eyes in Hispanics. Optom Vis Sci. 2005 Mar;82(3):206-8. doi: 10.1097/01.opx.0000156310.45736.fa. PMID 15767875
• Johnson ME, Murphy PJ. Changes in the tear film and ocular surface from dry eye syndrome. Prog Retin Eye Res. 2004 Jul;23(4):449-74. doi: 10.1016/j.preteyeres.2004.04.003. PMID 15219877
• Jones L, Downie LE, Korb D, Benitez-Del-Castillo JM, Dana R, Deng SX, Dong PN, Geerling G, Hida RY, Liu Y, Seo KY, Tauber J, Wakamatsu TH, Xu J, Wolffsohn JS, Craig JP. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017 Jul;15(3):575-628. doi: 10.1016/j.jtos.2017.05.006. Epub 2017 Jul 20. PMID 28736343
• Kenrick CJ, Alloo SS. The Limitation of Applying Heat to the External Lid Surface: A Case of Recalcitrant Meibomian Gland Dysfunction. Case Rep Ophthalmol. 2017 Jan 16;8(1):7-12. doi: 10.1159/000455087. eCollection 2017 Jan-Apr. PMID 28203190

Identifiers

NCT: NCT03767530 · OF18-00006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗