Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Joanne F. Shen, M.D., Mayo Clinic

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

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): NCT02066051


Locations
Layout table for location information
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Joanne Shen, MD Mayo Clinic
Layout table for additonal 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    Key Record Dates
Results First Posted: November 25, 2015
Last Update Posted: November 25, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Dry Eye Syndromes
Rosacea
Lacrimal Apparatus Diseases
Eye Diseases
Skin Diseases