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The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in dry eye symptoms post-treatment, compared to pre-treatment.
The IPL module has FDA clearance (K142860) for a wide range of indications, including benign cavernous hemangiomas, benign venous malformations, telangiectasia, port-wine stains, pigmented lesions and erythema of rosacea. As shown by a retrospective study, in over 85% of the cases, using IPL in subjects with ocular rosacea also alleviated the symptoms of DED caused by MGD. No serious adverse events were recorded, suggesting that IPL therapy administered close to the ocular orbits is safe (provided that the eyes are shielded). However, the above mentioned study was retrospective. Therefore, additional evidence is needed in order to substantiate the hypothesis that alleviation of MGD symptom was facilitated by IPL treatments.
The aim of the current study is to assess the safety and efficacy of IPL treatment for reducing the symptoms of dry eye disease (DED) in subjects with MGD. The study hypothesis is that in a study population of subjects diagnosed with moderate to severe MGD, 4 sessions of IPL therapy with the M22 system, followed by expression of the MGs, will cause a significant increase in tear break-up time post-treatment, compared to pre-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of dry eye secondary to MGD | Experimental | Intervention: Treatment of dry eye symptoms secondary to MGD with the M22-IPL system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M22-IPL | Device | The IPL hand piece operates at a spectrum of 400-1200nm with 7 different filters that can be easily inserted to the hand piece to treat different conditions. The IPL hand piece also includes 2 different sapphire cooled light guides of 8x15mm and 15x35mm. The cut-off filters that will be used for this evaluation are filters blocking wavelengths of 560 and 595 nm. |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break-up time in seconds, using the standard Fluorescein staining method | The number of seconds that elapse between the last blink of the eye to the appearance of the first dry spot in the tear film | from Baseline to 3 weeks after the 3rd treatment and 3 weeks after the fourth/final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal fluorescein staining score, using the Baylor Scheme | The cornea will be viewed and logically divided to 5 zones: central, superior, inferior, temporal and nasal. In each of the 5 zones, grading will be as follows: 0 dots = 0; 1-5 dots = 1; 16-30 dots = 3; > 30 dots = 4; One point will be added to the score in case of 1 area of confluent staining. Two points will be added to the score in case of two or more areas of confluent staining. The total score is the sum of scores in the 5 zones |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events and serious adverse events | Evaluation will be done by subject's report and/or by the physician's judgment | 1 day after baseline; 1 week after baseline ; 3 weeks after baseline (Tx2); 6 weeks after baseline (Tx3); 9 weeks after baseline (Tx4/FU1); 12 weeks after baseline (FU2); and 15 weeks after baseline (FU3) |
Inclusion Criteria:
Able to read, understand and sign an Informed Consent (IC) form
18-80 years of age
Fitzpatrick skin type 1-4
Able and willing to comply with the treatment/follow-up schedule and requirements
At least 5 non-atrophied glands on each eye's lower eyelid
Current diagnosis of moderate to severe MGD in both eyes, including 2 of the following 5 criteria:
Women of child-bearing age are required to be using a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, Nuvaring and partner with vasectomy or abstinence) at least 3 months prior to enrollment and throughout the course of the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Dell, MD | Medical Director, Dell LAser Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaster Eye Center | Beverly Hills | California | 90211 | United States | ||
| Dell Laser Consultants |
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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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|
| from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment |
| Meibomian gland score, using the "Abbreviated MGD grading system for clinical trials" |
| from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment |
| Subjective symptoms, using the SPEED questionnaire | SPEED is a validated questionnaire for quantifying the subjective symptoms of DED. The questionnaire will be filled by the study investigator (with questions answered by the subject). In 4 symptoms are evaluated: (1) dryness, grittiness or scratchiness; (2) Soreness or Irritation; (3) Burning or watering; and (4) Eye fatigue. Two types of questions are asked about these symptoms: frequency and severity. In the Frequency questions, subjects evaluate the 4 symptoms above on a 0-3 scale: 0 = Never; 1 = Sometimes; 2 = Often; and 3 = All the time. In the Severity questions, subjects evaluate the 4 symptoms above on a 0-4 scale: 0 = No problems; 1 = Tolerable (not perfect but not uncomfortable); 2 = Uncomfortable (irritating but does not interfere with my day); 3 = Bothersome (irritating and interferes with my day); and (4) Intolerable (unable to perform my daily tasks). The total score is the sum of the Frequency answers and the Severity answers. | from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment |
| Tear Osmolarity in milliosmol/liter, using a lab-on-a-chip system to simultaneously collect and analyze the electrical impedance of a tear sample | In this current study, tear osmolarity will be measured using a lab-on-a-chip system to simultaneously collect and analyze the electrical impedance of a tear sample (TearLab, San Diego, CA, USA). A small tear sample of 50 nL will be collected from the lower meniscus, using a disposable test chip by passive capillary action, and transferred to the device. Several seconds after the transfer, readings will be given in milliOsmol/L | from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment |
| Lipid Layer Thickness in nanometers, using an interferometer | lipid layer thickness will be measured using an interferometer. In interferometry, when white light is projected over the cornea, a color interference pattern is produced due to specular reflection at the lipid-aqueous interface. The reflected colors from the tear film are captured on a high-resolution video. Each recorded pixel is analyzed, and compared with a color progression table. The output is expressed as interference color units (ICUS), which correlate with lipid layer thickness | from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment |
| immediate/short term skin response | Evaluation will be done by the physician judgment | At Baseline (Tx1); 3 weeks after baseline (Tx2); 6 weeks after baseline (Tx3); and 9 weeks after baseline (Tx4/FU1) |
| Subjective level of pain/discomfort. | Evaluation will be done by the subject, using a Visual Analog Scale (VAS) | At Baseline (Tx1); 3 weeks after baseline (Tx2); 6 weeks after baseline (Tx3); and 9 weeks after baseline (Tx4/FU1) |
| Austin |
| Texas |
| 78746 |
| United States |