Evaporative Dry Eye Disease Clinical Trial
Official title:
Lipiflow Effect on Lacrimal Meibum Composition and on Adverse Environmental Conditions in Subjects With Meibomian Gland Dysfunction
Meibomian glands are a kind of sebaceous gland located in the tarsus of lower and upper lids and their function is to express lipids to the tear film. The secretion of lipids, polar and no-polar, produced in the Meibomian glands is denominated as meibum and it forms the external layer of the tear film. Its thickness varies from 15 to 200 nm and it is related with the tear film stability and the evaporation of the tear film. The meibum composition is variable among participants, especially in those who suffer Meibomian gland dysfunction or dry eye disease. Meibomian gland dysfunction is the leading cause of ocular surface disease. Meibomian gland dysfunction management depends on its severity, but eyelid hygiene, including warming and expression of Meibomian gland, is recommended from clinical stage 1 and it has proven its efficacy. However, lack of participant compliance can be a problem when this therapy is prescribed. In the last few years, some devices have been developed to improve the efficacy of this therapy, as for example the application of Vectored Thermal Pulsation with the Lipiflow device. It has been reported that low relative humidity values increase evaporative rates in both dry eye participants and healthy participants. Also, our group has extensively proven the negative effect of adverse environments (in the Controlled Environment Laboratory (CELab)) in clinical variables such as tear stability, dry eye symptoms and corneal staining both in healthy and dry eye participants. Therefore, the hypothesis of this study is that improving the Meibomian gland secretion through the application of warm and pressure with Lipiflow device, meibum composition would change in participants with Meibomian gland dysfunction and they would be less affected by adverse environmental conditions simulated in a controlled environmental chamber. The study will try to assess the effect of Lipiflow on the meibum in patients exposed to controlled adverse environmental conditions.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 13, 2020 |
Est. primary completion date | October 13, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age of 18 or older. - Signature of informed consent form. - Ocular Surface Index (OSDI) questionnaire score more or equal 13. - Meibomian gland secretion score of the lower lid in both eyes less or equal 12 in the Meibomian Gland Yielding Liquid Secretion (MGYLS) Score. - At least 10 out of 15 functioning MG of the lower eyelid, evaluated with the Meibomian Gland Evaluator (MGE). Exclusion Criteria: - Any ocular pathology other than Ocular Surface Disease due Meibomian Gland Dysfunction (MGD). - Unwilling to abstain from the use of systemic or topical treatments for MGD or dry eye for the study duration (except for artificial tears, ocular lubricants or dietary supplements). - Unwilling to abstain from the use of systemic medications known to cause dryness for the study duration. - History of severe ocular inflammation or infection in the 6 previous months. - Eyelid abnormalities that affect lid function. - Any ocular surgery or trauma that may affect corneal sensitivity and/or normal tear distribution in the 6 previous months. - Contact lens use must be stopped 15 days before inclusion and will not be resumed until the end of the study. - Punctal plugs or punctal occlusion within the past three months. - Pregnancy or breastfeeding. |
Country | Name | City | State |
---|---|---|---|
Spain | Instituto Universitario de Oftalmobiología Aplicada (IOBA) | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tear break up time (TBUT) | Measure of tear film stability with fluorescein. Tear Break Up Time with fluorescein (TBUT): fluorescein sodium (Entod Research Cell United Kingdom Ltd, New Southgate, London, United Kingdom) will be instilled in the inferior conjunctiva. Tear film pattern will be observed through a slit lamp with blue light and yellow filter. Participants will be asked to blink three times and then maintain their eye open as longer as possible. The time between the last blink and the moment when the first black spot appears will be noted in seconds. This measure will be repeated three times and the average of them will be calculated. Measures lower than 8 seconds are considered no normal. | 3 months after treatment | |
Secondary | Meibomian Gland Score (MGS) 12 months after treatment | Meibomian Gland Evaluator device will be used. This instrument applies a constant pressure of 1.25g/gmm^2 in 8 glands on the lower lid during 10-15 seconds. Total of 15 glands are evaluated along the lower eyelid margin, consisting of five glands located in each of the temporal, central, and nasal regions. For each of the 15 glands, expressed secretion characteristics were graded as 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). This is the Meibomian Gland Score (MGS).
For data analysis, the MGS score for each eye was calculated based on the sum of the secretion grades for all 15 glands evaluated with a range of 0 to 45. Lower score means a better function of meibomian glands. |
12 months after treatment |
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