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This protocol will evaluate THERMIeyes® for its ability to treat periorbital skin laxity and wrinkles and monitor ocular surface changes and their effect on evaporative dry eye associated with MGD.
Subjects with skin laxity and evaporative dry eye will be recruited for enrollment in this study. Subjects must present with subjective and objective indicators for periorbital skin laxity and wrinkle grade of 2 or greater out of a 4 point scale. To qualify, subjects must present with high symptoms score on subjective Ocular Surface Disease Index© (OSDI©) Questionnaires (scores≥ 15); Rapid Tear Break up (< 5 seconds) and Grade ≥ 1 of Flourescein Staining in one area of the cornea. Each of these parameters are to be assessed prior to treatment and at each follow up visit. Treatment is to be performed on periorbital skin only around one eye of the subject using the THERMIeyes® standard protocol. This may result in some redness of the periorbital skin. Subjects are to be seen and treated 2-3 weeks apart for a total of 3 treatments. Subjects will be followed at 6 and 12 weeks after the final treatment. A Validated Grading Scale for Crow's Feet will be used to evaluate changes in skin wrinkles and dry eye signs and symptoms scores will be compared with pre-treatment findings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects between the ages of 40 - 70 | Subjects who present with signs of skin laxity & evaporation dry eye will receive 3 treatments with the THERMIeyes® 20 RF System and monitored for improvements in the conditions for which they have presented. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THERMIeyes® 20 RF System | Device | The masked evaluating physician will be blinded as to which eye is treated. The evaluation on all visits will be performed on both eyes by the masked physician who will not know which eye has been treated with the THERMIeyes® 20 RF System. The treating technician will be aware of the treated eye so as to ensure all treatments are performed to the same eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Laxity | Subjective and Objective improvement in skin laxity and wrinkles using the validation Grading Scale for Crow's Feet • To identify an improvement in the signs of dry eye defined as a decrease in total corneal staining after treatment compared with pre-treatment findings. | 5 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface changes | Improvement in dry eye symptoms defined by a decrease in the OSDI score by 25% and decrease in total corneal staining | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects presenting with a Crow Feet Grading score of 2 or greater for skin laxity around their periorbital area and an OSDI score of 15 or greated
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carla DelCastillo | Contact | 516-593-4026 | cdelcastillo@ocli.net |
| Name | Affiliation | Role |
|---|---|---|
| Gerard D'Aversa, MD | Ophthalmic Consultants of Long Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Consultants of Long Island | Recruiting | Lynbrook | New York | 11563 | United States |
We will not be sharing individual participant data with other researchers but do plan to present the total findings of the study.
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |