Effects of Eyelid Warming Devices on Tear Film Parameters in Normal Subjects and Patients with Meibomian Gland Dysfunction.
Reiko Arita, Naoyuki Morishige, Rika Shirakawa...
https://pubmed.ncbi.nlm.nih.gov/26031204Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03767530
Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction
Led by Universidad Autonoma de Nuevo Leon · Updated on 2026-05-08
42
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
U
Universidad Autonoma de Nuevo Leon
Lead Sponsor
H
Hospital Universitario Dr. Jose E. Gonzalez
Collaborating Sponsor
AI-Summary
What this Trial Is About
Dry eye syndrome affects about 10 to 20% of people worldwide, with meibomian gland dysfunction (MGD) being a common cause. MGD occurs when the small glands in the eyelids that produce oils for the tear film become blocked or change, leading to faster tear evaporation and symptoms like eye irritation and inflammation. This study is evaluating whether thermal therapy using the MiBo Thermoflo device works better than the standard treatment of warm compresses and eyelid massage for dry eye caused by MGD. Participants will be randomly assigned to one of two treatment groups to compare these approaches over 24 weeks. One group will receive three sessions of thermal therapy with the MiBo Thermoflo device, each session 11 minutes per eye, spaced two weeks apart. The other group will use warm compresses and perform eyelid massage twice daily for 11 minutes per eye. Both groups will continue their usual dry eye care as needed during the study period. This design allows researchers to assess differences in treatment effects over time. Participants will be followed for 24 weeks, during which various eye health measures will be regularly checked. These include tests of gland function, tear quality and stability, eye surface staining, symptom questionnaires, and tear composition. Researchers will monitor safety and any adverse events throughout the study. The goal is to see if thermal therapy provides better relief and improvement compared to traditional warm compresses and massage therapy.
CONDITIONS
Brief Title
Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with dry eye syndrome with meibomian gland dysfunction alone or combined with other types of dry eye
- Patients who were previously treated with eyelid massages and warm compresses without improvement
- Adults aged 18 years or older
You will not qualify if you...
- Pregnant women
- History of ocular surgery within three months prior to inclusion
- History of trauma, infection, or inflammation within three months prior to inclusion
- Contact lens use in the last week before inclusion
- Patients with active ocular allergic disease
- Patients with microbial keratitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants receive either 3 sessions of thermal therapy with the Mibo Thermoflo device at 2-week intervals or apply warm compresses and eyelid massage twice daily.
3 treatment sessions for the Mibo Thermoflo group or twice daily self-care for the control group
Follow-up
Duration - 24 weeks
Participants are followed for 24 weeks to monitor treatment effectiveness and safety.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
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Research Team
K
Karim Mohamed-Noriega, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
TFOS DEWS II Definition and Classification Report.
Jennifer P Craig, Kelly K Nichols, Esen K Akpek...
https://pubmed.ncbi.nlm.nih.gov/28736335The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction.
Gerd Geerling, Joseph Tauber, Christophe Baudouin...
https://pubmed.ncbi.nlm.nih.gov/21450919Prevalence and severity of symptomatic dry eyes in Hispanics.
Milton Hom, Paul De Land
https://pubmed.ncbi.nlm.nih.gov/15767875Changes in the tear film and ocular surface from dry eye syndrome.
Michael E Johnson, Paul J Murphy
https://pubmed.ncbi.nlm.nih.gov/15219877TFOS DEWS II Management and Therapy Report.
Lyndon Jones, Laura E Downie, Donald Korb...
https://pubmed.ncbi.nlm.nih.gov/28736343The Limitation of Applying Heat to the External Lid Surface: A Case of Recalcitrant Meibomian Gland Dysfunction.
Christen J Kenrick, Sabiha S Alloo
https://pubmed.ncbi.nlm.nih.gov/28203190Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study.
Michael A Lemp, Leslie A Crews, Anthony J Bron...
https://pubmed.ncbi.nlm.nih.gov/22378109Disposable eyelid-warming device for the treatment of meibomian gland dysfunction.
Asako Mori, Jun Shimazaki, Shigeto Shimmura...
https://pubmed.ncbi.nlm.nih.gov/14636848The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee.
J Daniel Nelson, Jun Shimazaki, Jose M Benitez-del-Castillo...
https://pubmed.ncbi.nlm.nih.gov/21450914