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

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.

Study Overview

• Status: Unknown
• Conditions: Meibomian Gland Dysfunction; Skin Laxity
• Intervention / Treatment: Device: THERMIeyes® 20 RF System

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • New York
    • Lynbrook, New York, United States, 11563
      • Recruiting
      • Ophthalmic Consultants of Long Island
      • Contact: Carla DelCastillo; Phone Number: 516-593-4026; Email: cdelcastillo@ocli.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ophthalmic Consultants of Long Island
• Investigators: Principal Investigator: Gerard D'Aversa, MD, Ophthalmic Consultants of Long Island

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Anticipated): July 31, 2018
• Study Completion (Anticipated): July 31, 2019

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: OCLI-RFE-10D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not be sharing individual participant data with other researchers but do plan to present the total findings of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No