Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-03 @ 10:55 PM
Study NCT ID:
NCT03280069
Status:
UNKNOWN
Last Update Posted:
2017-09-12
First Post:
2017-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Ocular Surface Changes Following RF Electrocoagulation Treatment of the Periorbital Region
Sponsor:
Ophthalmic Consultants of Long Island
Organization:
Study Overview
Official Title:
Evaluation of Ocular Surface Changes Following RF Electrocoagulation Treatment of the Periorbital Region
Status:
UNKNOWN
Status Verified Date:
2017-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: