Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea

NCT03194698 | Completed Results FDA Device

• 1 other identifier: 16-008492
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Rosacea; Dry Eye

Keywords

Intense Pulsed Light

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 3 months

Secondary Outcomes (2)

• Change in Meibomian Glands Open - Right Lower Lid

  baseline, 3 months

• Change in Meibomian Glands Open - Left Lower Lid

  3 months

Study Arms (2)

MGX and Intense Pulsed Light Treatment (IPL)

EXPERIMENTAL

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

Device: Intense Pulsed Light Treatment (IPL); Procedure: Meibomian Gland Expression

Meibomian Gland Expression (MGX)

ACTIVE COMPARATOR

Treatment with 4 visits and 4 treatments of MGX only

Procedure: Meibomian Gland Expression

Interventions

Intense Pulsed Light Treatment (IPL) DEVICE

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.

MGX and Intense Pulsed Light Treatment (IPL)

Meibomian Gland Expression PROCEDURE

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.

MGX and Intense Pulsed Light Treatment (IPL); Meibomian Gland Expression (MGX)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

• 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.

  PMID: 33536740 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Rosacea; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Joanne F. Shen, M.D.
• Organization: Mayo Clinic

Shen.Joanne@mayo.edu

480-301-8085

Study Officials

• Joanne F Shen

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Ophthalmology - Arizona

Study Record Dates

• First Submitted: June 17, 2017
• First Posted: June 21, 2017
• Study Start: August 17, 2017
• Primary Completion: December 6, 2018
• Study Completion: December 6, 2018
• Last Updated: January 3, 2020
• Results First Posted: January 3, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)