Status:
COMPLETED
Effect of Thermal Pulsation System (Lipiflow) Treatment for Ocular Surface Disease Due to Meibomian Gland Dysfunction
Lead Sponsor:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Conditions:
Evaporative Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, prod...
Detailed Description
Justification: 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. Each gland consists of several ac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03843983
Start Date
March 25 2019
End Date
October 13 2020
Last Update
June 3 2021
Active Locations (1)
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1
Instituto Universitario de Oftalmobiología Aplicada (IOBA)
Valladolid, Spain, 47012