An interventional study of IPL and Meibomian Gland Expression in GVHD, Ocular Rosacea and Dry Eye Syndrome, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2015-11-25.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
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.
231 studies on the registry are indexed under Rosacea; 20 are open to participants now.
This study's enrollment of 8 is below the median of 61 across 199 interventional studies indexed under Rosacea.
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Exclusion Criteria:
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 · Procedure: Meibomian Gland Expression
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.
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.
Time frame: 12 months
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.
Time frame: 12 months
Subjects were recruited from the Mayo Clinic in Arizona.
| Milestone | IPL Treatment |
|---|---|
| Started | 8 |
| Completed | 7 |
| Not completed | 1 |
| Withdrew: Subject developed active gvhd | 1 |
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.
| participants | IPL Treatment |
|---|---|
| Participants who responded positively to IPL | 5 |
| Participants who did not respond to IPL | 2 |
Participants were screened for any sign of adverse events at each visit by the principal investigator or one of her colleagues.
| participants | IPL Treatment |
|---|---|
| Number of Participants Who Experienced Adverse Events | 0 |
Collected over Adverse events were collected over 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IPL Treatment | — | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | IPL Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | IPL Treatment |
|---|---|
| Female | 5 |
| Male | 3 |
| Region of Enrollment(participants) | IPL Treatment |
|---|---|
| United States | 8 |
The record gives a start of Oct 2013, a primary completion of Nov 2014 and a completion of Nov 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2015, 1 year after primary completion.
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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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