Recruiting

RF Electrocoagulation

Sponsor:

Ophthalmic Consultants of Long Island

Code:

NCT03280069

Conditions

Skin Laxity

Meibomian Gland Dysfunction

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

Interventions

THERMIeyes® 20 RF System

Study Details

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

Study ID

NCT03280069

Start date

Jul 25, 2017

Status verified date

Sep, 2017

Completion date

Jul 31, 2019

Anticipated

Primary completion date

Jul 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Skin Laxity [ Time Frame: 5 Months ]

Central Contacts and Locations

Central contacts

Carla DelCastillo

516-593-4026cdelcastillo@ocli.net

Locations

Ophthalmic Consultants of Long Island

Recruiting

Lynbrook, New York, United States, 11563

Contacts

Carla DelCastillo

516-593-4026cdelcastillo@ocli.net

More Information

Sponsor

Ophthalmic Consultants of Long Island

Last update posted

Sep 12, 2017

Last verified

Sep, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ophthalmic Consultants of Long Island on 2017-09-12.