Ocular Rosacea, Dry Eye
Conditions
Keywords
Intense Pulsed Light
Brief summary
Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long term improvement of symptoms for patients by improving the quality of meibum, increasing meibum flow, improving tear film stability and decreasing inflammation. Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation, topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers, intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses, among other. Despite this variety of symptoms, patients often do not experience complete or long term relief of symptoms. Forced meibomian gland expression (MGX) has been shown to be an effective method of rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are forcefully compressed to express gland contents. Research has shown improvement in patient symptoms with the use of MGX. Intense pulsed light (IPL) have been used in dermatology to treat various conditions. Patients with DED who have tried other therapies and found no relief, often resort to IPL as a last resort. Research has shown IPL alone may be effective in improving patient symptoms. In addition, such studies have failed to show significant adverse events with the use of IPL. Here, we propose a prospective, randomized, case controlled clinical pilot study to examine the efficacy for both subjective and objective measures. 20 patients with DED will be recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL. Objective measures will include tear cytokine levels, impression cytology, meibography, tear osmolarity and others. Subjective measures will include quality of life screening tools. We hypothesize that the use of MGX with IPL will lead to greater improvement in subjective dry eye symptoms and objective measures. Given the lack of adverse effects reported in the literature, we do not anticipate adverse effects in our study. Rochester staff Drs. Faustch and Bourne are providing clinical research advice but have no contact with subjects or biospecimens.
Interventions
DEVICEIntense Pulsed Light Treatment (IPL)
IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments.
PROCEDUREMeibomian Gland Expression
Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Dry eye of moderate severity with ocular rosacea diagnosed by ophthalmologist. No contraindications of severe ocular surface disease or inability to be safely treated with IPL. Dry eye symptoms must be alleviated with topical anesthetic. No GVHD, Stevens Johnson, active allergic conjunctivitis or other conjunctivitis, alkali burn history. Subjects must have at least 50% meibomian glands viable on meibography and no new treatments for dry eye in the past 6 months. Contact lenses and refractive surgery is okay.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score | baseline, 3 months | Symptom survey on severity of dry eye symptoms. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to none of the time and 4 corresponding to all of the time. A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Meibomian Glands Open - Right Lower Lid | baseline, 3 months | The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye. |
| Change in Meibomian Glands Open - Left Lower Lid | 3 months | The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MGX and Intense Pulsed Light Treatment (IPL) Treatment with 4 visits and 4 treatments of IPL and Meibomian Gland Expression (MGX)
Intense Pulsed Light Treatment (IPL): IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments.
Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye. | 10 |
| Meibomian Gland Expression (MGX) Treatment with 4 visits and 4 treatments of MGX only
Meibomian Gland Expression: Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | MGX and Intense Pulsed Light Treatment (IPL) | Meibomian Gland Expression (MGX) | Total |
|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 11.7 | 60.5 years STANDARD_DEVIATION 12.1 | 59.9 years STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized Hispanic/Latino | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Disclosed | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 9 Participants | 18 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score
Symptom survey on severity of dry eye symptoms. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to none of the time and 4 corresponding to all of the time. A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.
Time frame: baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MGX and Intense Pulsed Light Treatment (IPL) | Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score | -25.9 percentage of change in OSDI score | Standard Deviation 20 |
| Meibomian Gland Expression (MGX) | Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score | -2.0 percentage of change in OSDI score | Standard Deviation 17.9 |
p-value: 0.0312Wilcoxon (Mann-Whitney)
Secondary
Change in Meibomian Glands Open - Left Lower Lid
The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MGX and Intense Pulsed Light Treatment (IPL) | Change in Meibomian Glands Open - Left Lower Lid | 14.4 percentage of blocked meibomian | Standard Deviation 16.1 |
| Meibomian Gland Expression (MGX) | Change in Meibomian Glands Open - Left Lower Lid | 10.0 percentage of blocked meibomian | Standard Deviation 14.1 |
p-value: 0.74Wilcoxon (Mann-Whitney)
Secondary
Change in Meibomian Glands Open - Right Lower Lid
The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
Time frame: baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MGX and Intense Pulsed Light Treatment (IPL) | Change in Meibomian Glands Open - Right Lower Lid | 6.9 percentage of blocked meibomian pores | Standard Deviation 11 |
| Meibomian Gland Expression (MGX) | Change in Meibomian Glands Open - Right Lower Lid | 5.0 percentage of blocked meibomian pores | Standard Deviation 11 |
p-value: 0.79Wilcoxon (Mann-Whitney)