IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD

• ClinicalTrials.gov Identifier: NCT02066051
• Recruitment Status: Completed
• First Posted: February 19, 2014
• Results First Posted: November 25, 2015
• Last Update Posted: November 25, 2015
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Joanne F. Shen, M.D., Mayo Clinic

Study Description

Brief Summary:

The purpose of this study was to see if Intense Pulsed Light (IPL) can be used safely and effectively to help treat dry eyes from ocular rosacea after chronic graft-versus-host disease (GVHD). Current treatment options for this disease are limited.

Condition or disease	Intervention/treatment	Phase
GVHD; Ocular Rosacea; Dry Eye Syndrome	Device: IPL; Procedure: Meibomian Gland Expression	Not Applicable

Detailed Description:

Ocular rosacea and meibomian gland disease are major contributors to keratoconjunctivitis sicca after chronic GVHD. Rosacea exacerbates the aqueous deficiency caused by damage to lacrimal and accessory lacrimal glands similar to cholestasis damage in the biliary system.

Subjects who had inactive chronic GVHD after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea were recruited and treated with 4 monthly sessions of IPL and meibomian gland expression. Their charts were reviewed prior to treatment to confirm quiescence of active systemic disease. Symptom scores were quantified with Ocular Surface Disease Index (OSDI) and Standard Patient Evaluation of Eye Dryness questionnaire (SPEED2). Baseline complete eye exam was performed, and subjects received an eyes assessment score based on the Chronic Graft-Versus-Host Disease (GVHD) Assessment and Scoring Form.

Symptoms, exam, and diagnostic data were obtained at baseline (month 0, month 1, month 2, month 3, month 4, month 5, month 6, month 9 and month 12). IPL treatment and meibomian gland expression was performed at baseline (month 0), month 1, month 2, and month 3.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intense Pulsed Light (IPL) and Meibomian Gland Expression to Treat Ocular Rosacea Secondary to Inactive Chronic Ocular Graft Versus Host Disease (GVHD)
• Study Start Date: October 2013
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm

Intervention/treatment

Experimental: IPL Treatment; Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.

Device: IPL; Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.; Procedure: Meibomian Gland Expression; After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Responded to Intense Pulsed Light (IPL) [ Time Frame: 12 months ]
   Participants received treatment over 4 months and were monitored for safety and response for an additional 8 months. The symptoms were scored with the Standard Patient Evaluation of Eye Dryness (SPEED2) questionnaire. The SPEED questionnaire presents the four most commonly experienced dry eye symptom groups and asks patients to tick a box for all symptoms that apply to them. The frequency section ratings run from 0 (never) to 3 (constant), and the severity section ratings run from 0 (no problems) to 4 (intolerable), for a total score ranging from 0 (no problem) to 28 (severe problems). Over a 30% improvement in the SPEED2 score equated a response. None of the subjects were expected to get a complete response due to the nature of the damage to their ocular surface from GVHD.

Secondary Outcome Measures :

1. Number of Participants Who Experienced Adverse Events [ Time Frame: 12 months ]
   Participants were screened for any sign of adverse events at each visit by the principal investigator or one of her colleagues.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Ocular rosacea with inactive GVHD

Exclusion Criteria:

• Active GVHD
• Facial laser treatment
• Accutane exposure
• Inability to wear sun protection factor (SPF) 30 sunscreen and avoid sun exposure
• Inability to meet study requirements

Contacts and Locations

Locations

United States, Arizona

Mayo Clinic Arizona

Scottsdale, Arizona, United States, 85259

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Joanne Shen, MD; Mayo Clinic

More Information

• Responsible Party: Joanne F. Shen, M.D., Assistant Professor of Ophthalmology, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02066051
• Other Study ID Numbers: 13-003814
• First Posted: February 19, 2014
• Results First Posted: November 25, 2015
• Last Update Posted: November 25, 2015
• Last Verified: October 2015

Additional relevant MeSH terms:

Dry Eye Syndromes; Rosacea; Lacrimal Apparatus Diseases; Eye Diseases; Skin Diseases