Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea
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|ClinicalTrials.gov Identifier: NCT03194698|
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : December 7, 2018
Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long term improvement of symptoms for patients by improving the quality of meibum, increasing meibum flow, improving tear film stability and decreasing inflammation.
Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation, topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers, intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses, among other. Despite this variety of symptoms, patients often do not experience complete or long term relief of symptoms.
Forced meibomian gland expression (MGX) has been shown to be an effective method of rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are forcefully compressed to express gland contents. Research has shown improvement in patient symptoms with the use of MGX.
Intense pulsed light (IPL) have been used in dermatology to treat various conditions. Patients with DED who have tried other therapies and found no relief, often resort to IPL as a last resort. Research has shown IPL alone may be effective in improving patient symptoms. In addition, such studies have failed to show significant adverse events with the use of IPL.
Here, we propose a prospective, randomized, case controlled clinical pilot study to examine the efficacy for both subjective and objective measures. 20 patients with DED will be recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL. Objective measures will include tear cytokine levels, impression cytology, meibography, tear osmolarity and others. Subjective measures will include quality of life screening tools.
We hypothesize that the use of MGX with IPL will lead to greater improvement in subjective dry eye symptoms and objective measures. Given the lack of adverse effects reported in the literature, we do not anticipate adverse effects in our study.
Rochester staff Drs. Faustch and Bourne are providing clinical research advice but have no contact with subjects or biospecimens.
|Condition or disease||Intervention/treatment||Phase|
|Ocular Rosacea Dry Eye||Device: IPL Procedure: MGX||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Examine Efficacy and Cytokines Levels After Meibomian Gland Expression (MGX) With and Without Intense Pulsed Light Treatment (IPL)|
|Actual Study Start Date :||August 17, 2017|
|Actual Primary Completion Date :||December 6, 2018|
|Actual Study Completion Date :||December 6, 2018|
Treatment with 4 visits and 4 treatments of IPL and MGX
Intense Pulsed Light with Meibomian Gland Expression
Meibomian Gland Expression
Active Comparator: Control
Treatment with 4 visits and 4 treatments of MGX only
Meibomian Gland Expression
- Ocular Surface Disease Index symptom survey [ Time Frame: 4 months ]symptom survey on severity of dry eye symptoms
- Pathologic microbial load [ Time Frame: 4 months ]Analysis of RNA of ocular microbiome in tear sample
- TGF-B1 growth cytokine level [ Time Frame: 4 month ]Analysis of growth cytokines in tear sample
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194698
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|Principal Investigator:||Joanne F Shen||Mayo Clinic|