Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPL Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPL | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joanne Shen, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States |
Not provided
Subjects were recruited from the Mayo Clinic in Arizona.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 12 months |
|
Adverse events were collected over 1 year.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joanne F. Shen | Mayo Clinic | 480-301-8377 | shen.joanne@mayo.edu |
Not provided
| ID | Term |
|---|---|
| D012393 | Rosacea |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Meibomian Gland Expression | Procedure | 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. |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Number | participants | 12 months |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
Not provided
Not provided
Not provided