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

NCT03843983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-06-03

No results posted yet for this study

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

Interventions

DEVICE

Lipiflow® application

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Margarita Calonge Cano, MD, PhD · Study Principal Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2020-10-13
Completion
2020-10-13

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03843983 on ClinicalTrials.gov