NCT Number: NCT03767530
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Monterrey, Nuevo León, 64460, Mexico
Location status: Recruiting
Karim Mohamed-Noriega, M.D.
CONTACT
[email protected], [email protected]
Karim Mohamed-Noriega, M.D.
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Thermal therapy with Mibo Thermoflo for 11 minutes per eye, during each session.
Warm compresses plus eyelid massage 2 times per day 11 minutes per eye.
Time frame: Basal to 24 weeks
Changes in meibomian gland structure will be evaluated by meibomian gland expressibility.
Time frame: Basal to 24 weeks
Changes in meibomian gland structure will be evaluated with the meibum quality in slit lamp graded as: clear, opaque, granular and toothpaste for meibum worst secretion.
Time frame: Basal to 24 weeks
Ocular surface damage will be graded with corneal and conjunctival staining with fluorescein dye.
Time frame: Basal to 24 weeks
Ocular surface damage will be graded with corneal and conjunctival staining with lissamine green dye.
Time frame: Basal to 24 weeks
Tear stability will be measured with Tear Break-up Time (TBUT). A result >10 seconds will be considered normal, a result <10 seconds will be considered pathological.
Time frame: Basal to 24 weeks
Tear production will be measured by Schirmer test with and without anesthesia. A Schirmer test >10 mm will be considered normal, a result >5 mm pathological. The Schirmer test with anesthesia >15 mm is consider normal.
Time frame: Basal to 24 weeks
Ocular surface symptoms will be assessed by the Symptom Assessment in Dry Eye (SANDE) questionnaire. The SANDE questionnaire has two questions presented in a visual scale. The two questions assess the frequency and severity of dry eye symptoms.
Time frame: Basal to 24 weeks
Ocular surface symptoms will be assessed by the Ocular Surface Disease Index (OSDI). The OSDI questionnaire consists of 12 questions that assess dry eye symptoms and their effects on vision related function. The questionnaire is divided in 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients are asked to rate their responses on a 0 to 4 scale where 0 represents "none of the time", 1 "some of the time", 2 "half of the time", 3 "most of the time", and 4 "all of the time". The total score is calculated using the following formula: ([sum of scores for all questions answered x 100] / [total number of questions answered x 4]). Lower scores represent a better outcome.
Time frame: Basal to 24 weeks
Ocular surface symptoms will be assessed by the Dry Eye Questionnaire 5 (DEQ-5). The Dry Eye Questionnaire 5 asses habitual dry eye symptoms (discomfort, dryness and wetty eyes) and severity level.
Time frame: Basal to 24 weeks
Patients with dry eye have increased levels of tear osmolarity wich is one of tear inflammation biomarkers. Tear osmolarity will be performed with Tear Lab Osmolarity System, a result of 308 mOsm/L or higher indicates dry eye disease.
Time frame: Basal to 24 weeks
MMP-9 is an inflammatory biomarker wich is elevated in the tears of patients with dry eye and an early diagnostic evaluation, it is realized in consulting room with the InflammaDry test (Rapid Pathogen Screening Inc.). The presence of 1 line is a negative result and two lines means positive result.
Time frame: Basal to 24 weeks
NIKBUT will be measured with Keratograph 5M. A JENVIS Dry Eye report will be generated to document findings.
Time frame: Basal to 24 weeks
Tear meniscus height will be measured with Keratograph 5M. A JENVIS Dry Eye report will be generated to document findings.
Time frame: Basal to 24 weeks
Conjuctival hypermeia will be graded with JENVIS Scale performed by Keratograph 5M. A JENVIS Dry Eye report will be generated to document findings. Conjuctival hyperemia will be . graded as: none, mild moderate or severe.
Time frame: Basal to 24 weeks
Lipid layer thickness will be measured with Keratograph 5M. A JENVIS Dry Eye report will be generated to document findings.
Time frame: Basal to 24 weeks
Adverse events will be evaluated during the ophthalmic evaluation.
Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in ocular surface damage will be graded 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 in ocular surface damage will be graded with corneal and conjunctival staining with lissamine green dye.
Time frame: These parameterd will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in tear stability will be measured with Tear Break-up Time (TBUT). A result >10 seconds will be considered normal, a result <10 seconds will be considered pathological.
Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in ocular surface symptoms will be assessed by the Symptom Assessment in Dry Eye (SANDE). The SANDE questionnaire has two questions presented in a visual scale. The two questions assess the frequency and severity of dry eye symptoms. A less rate prove changes in ocular surface symptoms and quality of life improvement.
Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in ocular surface symptoms will be assessed by the Ocular Surface Disease Index (OSDI). The OSDI questionnaire consists of 12 questions that assess dry eye symptoms and their effects on vision related function. The questionnaire is divided in 3 subscales: ocular symptoms, vision-related function, and environmental triggers.. A less rate prove changes in ocular surface symptoms and quality of life improvement.
Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in ocular surface symptoms will be assessed by the Dry Eye Questionnaire 5 (DEQ-5). The Dry Eye Questionnaire 5 asses habitual dry eye symptoms (discomfort, dryness and wetty eyes) and severity level. A less rate prove changes in coular surface symptoms and quality of life improvement.
Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Eyelid skin temperature will be measured with the thermographic infrared scientific equipment FLIR SC4000 to verify if 42 celsius degree are obtain as maker recommends.
Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Corneal conjunctival temperature will be measured with the thermographic infrared scientific equipment FLIR SC4000 to verify if 42 celsius degree are obtain as maker recommends.
Time frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Bulbar conjunctival temperature will be measured with the thermographic infrrared scientific equipment FLIR SC4000 to verify if 42 celsius degree are obtain as maker recommends.
Time frame: These parameters will be evaluated before sessions of thermal therapy at week 2 and week 4.
Tarsal conjunctival temperature will be measured with the thermographic infrared scientific equipment FLIR SC4000 to verify if 42 celsius degree are obtain as maker recommends.
Contact information is provided by the study sponsor or research team.
Universidad Autonoma de Nuevo Leon
Other
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