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

NCT03280069 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2017-09-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ophthalmic Consultants of Long Island

    lead OTHER

Principal Investigators

  • Gerard D'Aversa, MD · Ophthalmic Consultants of Long Island

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2018-07-31
Completion
2019-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03280069 on ClinicalTrials.gov