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| ID | Type | Description | Link |
|---|---|---|---|
| 0171-17-SZMC | Other Identifier | Shaarei Zedek Hospital |
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The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by expression of the meibomian glands. In the control arm, subjects will undergo the same treatments, except that the IPL pulses will be disabled. For each subject, the duration of the study will be 10 weeks, as explained in the detailed description,
Outcome measures (tear break-up time, tear film osmolarity, meibomian gland assessment, number of meibomian glands yielding liquid secretion in lower eyelid , meibography, self-assessed symptoms and close up photos of the lid margins) will be measured at baseline. All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with IPL administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the IPL administration, the meibomian glands will be manually expressed from both eyelids. Subjects in the control arm will receive exactly the same treatment, except that the IPL administration will be sham. A single follow-up will occur at 10 weeks after the baseline (or 4 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms.
For each subject, the duration of the study will be 10 weeks: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 10 weeks after baseline).
Statistically significant differences between the two arms will support the study hypothesis that IPL treatment itself provides relief to both signs and symptoms of dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intense Pulsed Light (IPL) therapy | Experimental | Subjects with receive 10-15 intense pulsed light (IPL) pulses on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid. Following the administration of IPL pulses, subjects will undergo meibomian gland expression. |
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| Sham therapy | Placebo Comparator | Participants will undergo a sham treatment that will mimic the intense pulsed light (IPL) therapy. The tip of the IPL lightguide will be placed in 10-15 locations on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid, but IPL pulses will not be actually delivered. Following this sham procedure, subjects will undergo meibomian gland expression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intense Pulsed Light (IPL) therapy | Device | Intense pulsed light therapy is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications on 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of baseline TBUT | Change of Tear break up time in the study eye, from baseline to follow-up | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline MGA | Change of Meibomian gland secretion score, from baseline to follow-up, in both eyes | 10 weeks |
| Change from baseline OSDI | Change of self-assessed symptoms with the OSDI questionnaire, from baseline to follow-up, in both eyes |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline MGYLS | Change of the number of meibomian glands yielding liquid secretion, from baseline to the follow-up | 10 weeks |
| Change from baseline TFO | Change of the tear film osmolarity, from baseline to the follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Zadok, MD | Shaarei Zedek Hospital ( Jerusalem) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek | Jerusalem | Israel |
At this point it is not yet decided if and how to share IPD with other researchers
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with IPL and meibomian gland expression. Subjects in the control arm will be treated with sham and meibomian gland expression.
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Subjects in the study arm will receive a series of IPL pulses using the M22 IPL handpiece. In subjects of the control arm, the device will be disabled. The subject will feel the lightguide on the skin, will hear clicking sounds, but no light will be actually produced by the M22 device. Since during treatment both eyes of the subject will be fully occluded, no subject will be able to see if the treatment is actual or sham. There is no way to completely mask the subjects, since the IPL generally causes slight redness of the skin, and in some patients is may also cause some discomfort
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| Sham therapy | Device | Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include a sham application of IPL on 10-15 locations in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps. |
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| 10 weeks |
| 10 weeks |
| Change from baseline Meiboscore | Change of the Meiboscore evaluated with meibography, from baseline to the follow-up | 10 weeks |
| Percentage of study eyes with normal TBUT | Percentage of study eyes with TBUT > 10 seconds at the follow-up | 10 weeks |
| Percentage of subjects with normal OSDI | Percentage of subjects with OSDI < 23 at the follow-up | 10 weeks |
| Percentage of subjects with normal MGA | Percentage of eyes with MGA > 12 at the follow-up | 10 weeks |
| Qualitative assessment of eyelid appearance | High resolution photos of the upper and lower eyelids in both eyes | 10 weeks |