IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD
Intense Pulsed Light (IPL) and Meibomian Gland Expression to Treat Ocular Rosacea Secondary to Inactive Chronic Ocular Graft Versus Host Disease (GVHD)
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 13, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
November 25, 2015
CompletedNovember 25, 2015
October 1, 2015
1.1 years
February 13, 2014
October 25, 2015
October 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Responded to Intense Pulsed Light (IPL)
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.
12 months
Secondary Outcomes (1)
Number of Participants Who Experienced Adverse Events
12 months
Study Arms (1)
IPL Treatment
EXPERIMENTALSubjects 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Ocular rosacea with inactive GVHD
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Joanne F. Shen
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne Shen, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Ophthalmology
Study Record Dates
First Submitted
February 13, 2014
First Posted
February 19, 2014
Study Start
October 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
November 25, 2015
Results First Posted
November 25, 2015
Record last verified: 2015-10