Clinical Study: Thermomechanical Innovation in Dry Eye Treatment: How Tixel Compares to LipiFlow

The Smart Group
By The Smart Group

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Dry eye sufferers know the frustration of discomfort, irritation, and ongoing treatment routines. A new clinical study offers hope: a thermomechanical action (TMA) device known as Tixel C may be just as effective—and potentially more convenient—than traditional thermal pulsation methods. This blog explores the key findings of a recent multicentre, randomised study comparing Tixel to the established LipiFlow system, shedding light on what this could mean for Meibomian Gland Dysfunction (MGD) treatment.

 

Effectiveness_and_safety_of_a_thermomechanical.-Novoxel.pdf

To view the PDF please click here.

Understanding Meibomian Gland Dysfunction (MGD)

  • MGD affects up to 68% of people over 40, contributing to evaporative dry eye.
  • It's caused by blockages in the meibomian glands, disrupting the tear film and leading to irritation.
  • Traditional first-line therapy includes warm compresses and eyelid hygiene, but patient compliance is low.

Study Overview: Tixel vs LipiFlow

  • Design: Randomised, evaluator-masked trial conducted across five U.S. sites.
  • Participants: 106 adults with MGD symptoms and clinical indicators.
  • Treatment Arms:
    • Tixel: Three 2-weekly sessions applying localised heat via a non-contact thermal tip.
    •  LipiFlow: A single session using in-eye thermal pulsation.

Key Findings: Safety & Effectiveness

1. Tear Break-Up Time (TBUT)

- Both devices showed significant improvement at 4 and 12 weeks.

- Tixel was non-inferior to LipiFlow, meeting the primary study endpoint.

 

2. Symptom Relief (OSDI Scores)

- OSDI scores improved in both groups, with slightly greater gains in the Tixel group at 12 weeks.

 

3. Gland Function (MGS Scores)

- Both groups experienced notable improvements in meibomian gland function.

 

4. Drop Usage and Pain Scores

- Participants used fewer lubricant drops post-treatment, with mild discomfort reported in both groups.

- Pain scores were slightly higher for Tixel but remained low overall.

Why Tixel Stands Out

- Radiation-Free: Tixel uses brief thermal pulses with no radiation or gel required.

- No Eye Contact: The device doesn’t touch the ocular surface, enhancing comfort.

- Portable and Efficient: Each session takes just 2 minutes per eye.

- FDA Cleared: Tixel is now cleared for evaporative dry eye treatment in the US.

Conclusion

This clinical trial shows that Tixel is a safe and effective alternative to LipiFlow for treating MGD-related dry eye. With its non-contact design and efficient treatment time, it offers eye care professionals a compelling new tool for managing a widespread and often debilitating condition.

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