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Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD

NCT06220474 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-04-27

No results posted yet for this study

Summary

The goal of this prospective, 24-week, double-masked, randomized, sham-controlled clinical trials to compare clinical efficacy and safety of RF and MGX with MGX alone in patients with meibomian gland dysfunction-related dry eye disease. The main question it aims to answer is whether radiofrequency treatment and meibomian gland expression is more effective in improving tear breakup time, as measured using non-invasive video keratography, compared with meibomian gland expression alone, in patients with refractory meibomian gland dysfunction-related dry eye disease.

Participants will be divided into two groups, one group will receive RF treatment followed with MGX and another will receive sham treatment with MGX.

Conditions

  • Dry Eye Syndromes
  • Meibomian Gland Dysfunction

Interventions

DEVICE

The Thermage FLX System

The Thermage FLX System is tested for its therapeutic efficacy and safety on treating refractory Meibomian Gland Dysfunction

DEVICE

Sham treatment

Sham treatment acts as a control to test the therapeutic efficacy and safety of The Thermage FLX System

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Kendrick Co SHIH · The University of Hong Kong, Grantham Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2027-10-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • Hong Kong

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 NCT06220474 on ClinicalTrials.gov