NCT03280069

Evaluation of Ocular Surface Changes Following RF Electrocoagulation Treatment of the Periorbital Region

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Ophthalmic Consultants of Long Island · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Skin Laxity
• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DEVICE	THERMIeyes® 20 RF System	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.

Timeline

• Start date: 2017-07-25
• Primary completion: 2018-07-31
• Completion: 2019-07-31
• First posted: 2017-09-12
• Last updated: 2017-09-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study