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The purpose of this study is to verify the safety of tinted soft scleral eye shields when IPL is applied directly on eyelids.
Patients with dry eye disease due to meibomian gland dysfunction will be treated with one session of IPL applied directly on upper and lower eyelids, when eyes are protected with tinted soft scleral eye shields which prevent IPL from penetrating into ocular structures. Ocular structures will be examined with various tests (including: biomicroscopy, OCT and specular microscopy) at baseline and at 10 minutes after IPL, 24 hours after IPL, and 7 days after IPL. In addition, visual acuity will be measured at each of these times, and the patient will report of any visual symptoms at each of these times. The primary objective is to verify that no morphological or functional changes occur between the baseline and the 7 days follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Protection of eyes with tinted soft scleral eye shields followed by IPL administration directly on eyelids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protection of eyes with tinted soft scleral eye shields | Combination Product | In subjects with dry eye disease due to meibomian gland dysfunction, protection of eyes with tinted soft scleral eye shields followed by IPL administration on eyelids |
| Measure | Description | Time Frame |
|---|---|---|
| Ophthalmic morphological changes at 1 week after intervention | Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 1 week after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Ophthalmic morphological changes at 10 minutes after intervention | Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 10 minutes after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy) | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
• Fitzpatrick skin type VI
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| Name | Affiliation | Role |
|---|---|---|
| Rolando Toyos, MD | Toyos Clinic (Nashville, TN, USA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toyos Clinic | Nashville | Tennessee | 37215 | United States |
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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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| Ophthalmic morphological changes at 24 hours after intervention | Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 24 hours after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy) | 24 hours |
| Objective functional change at 10 minutes after intervention | Change in best-corrected visual acuity (ETDRS chart) at 10 minutes after intervention | 10 minutes |
| Objective functional change at 24 hours after intervention | Change in best-corrected visual acuity (ETDRS chart) at 24 hours after intervention | 24 hours |
| Objective functional change at 1 week after intervention | Change in best-corrected visual acuity (ETDRS chart) at 1 week after intervention | 1 week |
| Subjective functional change at 10 minutes after intervention | Change in perception of visual symptoms (Visual analog scale) at 10 minutes after intervention | 10 minutes |
| Subjective functional change at 1 day after intervention | Change in perception of visual symptoms (Visual analog scale) at 1 day after intervention | 1 day |
| Subjective functional change at 1 week after intervention | Change in perception of visual symptoms (Visual analog scale) at 1 week after intervention | 1 week |