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

NCT03280069 | Unknown FDA Device

• 1 other identifier: OCLI-RFE-10D
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Laxity; Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ocular Surface changes

  3 Months

Study Arms (1)

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

Interventions

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.

Subjects between the ages of 40 - 70

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ophthalmic Consultants of Long Island: lead

Study Sites (1)

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

RECRUITING

MeSH Terms

Conditions

Cutis Laxa; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Eyelid Diseases; Eye Diseases

Study Officials

• Gerard D'Aversa, MD

  Ophthalmic Consultants of Long Island

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla DelCastillo

CONTACT

516-593-4026; cdelcastillo@ocli.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 12, 2017
• Study Start: July 25, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2019
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)