Effect of Thermal Pulsation System (Lipiflow) Treatment for Ocular Surface Disease Due to Meibomian Gland Dysfunction

NCT03843983 | Completed

• 1 other identifier: IOBA-2019-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Evaporative Dry Eye Disease

Keywords

Meibomian gland dysfunction; Lipiflow; Meibum composition; Adverse environmental conditions; Dry eye disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Meibomian Gland Score (MGS) 12 months after treatment

  12 months after treatment

Study Arms (1)

Lipiflow treatment

OTHER

Lipiflow® application: Treated with Lipiflow. All patients in this study are treated with Lipiflow once.

Device: Lipiflow® application

Interventions

Lipiflow® application DEVICE

Lipiflow® will be applicated in both lids of each eye during 12 minutes once. Firstly, a drop of anesthetic will be instilled in each eye. Then, while the participant stays with his eyes closed, a one-used applicator will be placed covering the subject's lid. The instrument applies heat and pressure in the lid during 12 minutes. Time frame: between 2 and 7 days after visit 1. Then, there will be 3 follow-up visits in 3, 6 and 12 months after treatment.

Lipiflow treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Punctal plugs or punctal occlusion within the past three months.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA: lead

Study Sites (1)

Instituto Universitario de Oftalmobiología Aplicada (IOBA)

Valladolid, 47012, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• Margarita Calonge Cano, MD, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 18, 2019
• Study Start: March 25, 2019
• Primary Completion: October 13, 2020
• Study Completion: October 13, 2020
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)