Clinical trial NCT03280069: Evaluation of Ocular Surface Changes Following RF Electrocoagulation Treatment of the Periorbital Region
Official title: Evaluation of Ocular Surface Changes Following RF Electrocoagulation Treatment of the Periorbital Region
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skin Laxity
Meibomian Gland Dysfunction
Lead sponsor: Ophthalmic Consultants of Long Island
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: Inclusion Criteria:

* Subjects must be 40-70 Inclusive; Male or Female
* Subjects must demonstrate subjective and objective indicators for periorbital skin laxity and wrinkle grade of 2 or greater out of a 4 point scale
* Subjects must have an OSDI© score of ≥ 15,
* Subjects must have a Grade 1 or higher staining pattern with fluorescein stain in any area of the cornea.
* The subjects may continue their current treatment for dry eye including the use of artificial tears, gels or ointments. They are to continue any topical medications for dry eye such as Cyclosporin or Lifitegrast. Subjects may continue to take chronic medications systemically including anti-inflammatory medications (aspirin, NSAIDS, Prednisone) as long as the dose and frequency is not changed throughout the study.
* Subjects may be included if they have punctual plugs present in any tear duct. If a plug comes out during the study it may be re-inserted so that the Subject is returned to their pre-treatment baseline state.
* Women of childbearing years should have pregnancy testing performed to ensure that pregnancy has not occurred during the study. Urine pregnancy screening will be performed prior to any treatment and on follow up visits until the study is completed

Exclusion Criteria:

* The subject must meet the inclusion criteria as listed
* During the study they cannot have any new medications started that are anti-inflammatory in nature. This includes topical steroids, Lifitegrast, cyclosporine or systemic medications such as steroids, NSAIDS, aspirin, Doxycyline or other Macrolid antibiotics.
* Subjects cannot have a punctual plug inserted into a tear duct that has not had a plug present prior to the start of the study.
* Participation in other clinical trials during the course of this study is not permitted.
* Women who are pregnant or nursing.

Primary outcomes:
measure: Skin Laxity
timeFrame: 5 Months
Secondary outcomes:
measure: Ocular Surface changes
timeFrame: 3 Months
Other outcomes:
Locations:
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
Study officials:
affiliation: Ophthalmic Consultants of Long Island
name: Gerard D'Aversa, MD
role: PRINCIPAL_INVESTIGATOR
References: