Is Heat or Radiofrequency the Key to Treating Dry Eye Disease?

Effect of Radiotherapy Adjunctive to Surface Heating and Meibomian Gland Expression on Dry Eye Symptoms in Adults with Meibomian Gland Dysfunction

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000120370

Enrollment

Registered

2026-01-30

Start date

2026-03-01

Completion date

2026-04-01

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Dry eye disease is a common long-term condition that often occurs when the oil-producing glands in the eyelids become blocked and do not work properly. This study aims to find out whether radiofrequency treatment provides a marked improvement compared the first-line heat-based treatment which is heat masking. We hypothesise that radiofrequency treatment will be more effective than heat masking for patients with varying severities of dry eyes, which justifies the financial investment the machine requires. Participants will receive standard eyelid gland expression following either radiofrequency treatment for heat masking. The results will help inform decisions on deciding between radiofrequency and heat masking for patients with meibomian gland dysfunction.

Interventions

Brief name: Intervention arm: Radiofrequency therapy (RF) plus meibomian gland expression (MGX) for meibomian gland dysfunction Control arm: Heat masking plus meibomian gland expression for meibomian gland dysfunction Description: This study involves the comparison of meibomian gland expression following either radiofrequency treatment or heat masking for the management of meibomian gland dysfunction. Participants will be randomly allocated to either an intervention group or an active control group: Intervention (RF + MGX): Participants will receive RF therapy via the Envision® Forma-I RF device according to therapeutic guidelines (42°C effective temperature). After cleansing the periocular area, ultrasound gel will be applied, and RF will be delivered to the upper and lower eyelids using a continuous probe motion along the orbital rim for a total of 20 minutes. Therapeutic meibomian gland expression will be performed immediately after RF treatment, where the tarsal plates along the lid margin is mechanically squeezed to release obstructed gland contents. Sterile forceps will be used after topical anaesthetics to apply firm, controlled pressure. The total duration should not exceed 40 minutes. All treatments will be delivered face-to-face by trained optometrists at the UNSW School of Optometry and Vision Science clinic. Each participant will receive five treatment sessions, spaced two weeks apart over an 8-week period. To ensure adherence, a session attendance list will be used, and absentees will be contacted.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subject must be above 18 years of age 2. Subjects must have signs and symptoms of dry eye disease, defined as having: - OSDI-12 score >= 13 AND - meibomian gland secretion quality score <= 12 for 15 glands of the lower lid AND - EITHER: - a previous diagnosis of Meibomian Gland Dysfunction OR - one or both of the following tear homeostasis issues: - tear breakup time < 10 seconds - ocular surface damage >5 corneal spots, or >9 conjunctival spots

Exclusion criteria

1. Recent (<3 months) ocular surgery 2. Active ocular infection or inflammation 3. Current use of topical cyclosporin or topical corticosteroids 4. Use of topical ocular medications that is expected to change during the intervention period (or new treatments in last month) 5. Prescence of implanted electronic medical devices 6. Pregnancy or breastfeeding 7. Contact lens wear or use of contact lenses within the last month 8. Recent physical treatment (intense pulsed light, radiofrequency or quantum magnetic resonance therapy) for dry eye disease in the last 4 weeks.

Outcome results