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IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD

Primary Purpose

GVHD, Ocular Rosacea, Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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 GVHD

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Arizona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IPL Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Who Experienced Adverse Events
Participants were screened for any sign of adverse events at each visit by the principal investigator or one of her colleagues.

Full Information

First Posted
February 13, 2014
Last Updated
October 25, 2015
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02066051
Brief Title
IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GVHD, Ocular Rosacea, Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPL Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
IPL
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Meibomian Gland Expression
Intervention Description
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 Measure Information:
Title
Number of Participants Who Responded to Intense Pulsed Light (IPL)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants Who Experienced Adverse Events
Description
Participants were screened for any sign of adverse events at each visit by the principal investigator or one of her colleagues.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Shen, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

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IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD

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