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Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea

Primary Purpose

Ocular Rosacea, Dry Eye

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intense Pulsed Light Treatment (IPL)
Meibomian Gland Expression
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Rosacea focused on measuring Intense Pulsed Light

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Dry eye of moderate severity with ocular rosacea diagnosed by ophthalmologist. No contraindications of severe ocular surface disease or inability to be safely treated with IPL.

Dry eye symptoms must be alleviated with topical anesthetic. No GVHD, Stevens Johnson, active allergic conjunctivitis or other conjunctivitis, alkali burn history.

Subjects must have at least 50% meibomian glands viable on meibography and no new treatments for dry eye in the past 6 months.

Contact lenses and refractive surgery is okay.

Sites / Locations

  • Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MGX and Intense Pulsed Light Treatment (IPL)

Meibomian Gland Expression (MGX)

Arm Description

Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX)

Treatment with 4 visits and 4 treatments of MGX only

Outcomes

Primary Outcome Measures

Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score
Symptom survey on severity of dry eye symptoms. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.

Secondary Outcome Measures

Change in Meibomian Glands Open - Right Lower Lid
The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Change in Meibomian Glands Open - Left Lower Lid
The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.

Full Information

First Posted
June 17, 2017
Last Updated
December 14, 2019
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03194698
Brief Title
Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea
Official Title
Pilot Study to Examine Efficacy and Cytokines Levels After Meibomian Gland Expression (MGX) With and Without Intense Pulsed Light Treatment (IPL)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 17, 2017 (Actual)
Primary Completion Date
December 6, 2018 (Actual)
Study Completion Date
December 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Rosacea, Dry Eye
Keywords
Intense Pulsed Light

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MGX and Intense Pulsed Light Treatment (IPL)
Arm Type
Experimental
Arm Description
Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX)
Arm Title
Meibomian Gland Expression (MGX)
Arm Type
Active Comparator
Arm Description
Treatment with 4 visits and 4 treatments of MGX only
Intervention Type
Device
Intervention Name(s)
Intense Pulsed Light Treatment (IPL)
Intervention Description
IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments.
Intervention Type
Procedure
Intervention Name(s)
Meibomian Gland Expression
Intervention Description
Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Primary Outcome Measure Information:
Title
Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score
Description
Symptom survey on severity of dry eye symptoms. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.
Time Frame
baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in Meibomian Glands Open - Right Lower Lid
Description
The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Time Frame
baseline, 3 months
Title
Change in Meibomian Glands Open - Left Lower Lid
Description
The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Dry eye of moderate severity with ocular rosacea diagnosed by ophthalmologist. No contraindications of severe ocular surface disease or inability to be safely treated with IPL. Dry eye symptoms must be alleviated with topical anesthetic. No GVHD, Stevens Johnson, active allergic conjunctivitis or other conjunctivitis, alkali burn history. Subjects must have at least 50% meibomian glands viable on meibography and no new treatments for dry eye in the past 6 months. Contact lenses and refractive surgery is okay.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne F Shen
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33536740
Citation
Sagaser S, Butterfield R, Kosiorek H, Kusne Y, Maldonado J, Fautsch MP, Patel D, Shen JF. Effects of Intense Pulsed Light on Tear Film TGF-beta and Microbiome in Ocular Rosacea with Dry Eye. Clin Ophthalmol. 2021 Jan 27;15:323-330. doi: 10.2147/OPTH.S280707. eCollection 2021.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea

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