Advice

Summary

Summary

The LipiFlow system applies heat and gentle pressure to the eyelids to treat dry eyes caused by meibomian gland dysfunction. Two randomised controlled trials showed that the LipiFlow system was at least as effective as warm compresses and reported some improved patient‑reported outcomes. The LipiFlow system costs £35,500 with additional costs for consumables and software upgrades.

Product summary and likely place in therapy

  • The LipiFlow system applies heat to the inner eyelid and pressure to the outer eyelid surfaces at the same time. These actions are designed to loosen, liquefy and express hardened meibomian lipids, which have blocked the meibomian glands.

  • The LipiFlow system is intended to remove blockages to the meibomian glands, thereby relieving both dry eye symptoms and preventing meibomian gland atrophy.

  • The LipiFlow system could be used in primary care by optometrists, or in ophthalmology departments in secondary or tertiary care.

Effectiveness and safety

  • Two randomised controlled trials (n=139 and n=31) compared the efficacy and safety of the LipiFlow system with regular, self‑administered warm compresses, with or without massage, to the eyelids for people with obstructed meibomian glands. The first study showed that the LipiFlow system was more effective and the second study showed LipiFlow therapy was non‑inferior.

  • In the first trial, there was a statistically significant improvement in meibomian gland secretion and tear break‑up time after treatment with the LipiFlow system. Patient‑reported symptoms also statistically significantly improved after treatment, with the exception of pain and discomfort scores.

  • In the second trial, the number of expressible meibomian glands statistically significantly improved after treatment with the LipiFlow system. Patient‑reported symptoms statistically significantly improved after treatment.

  • A clinical feasibility study (n=14) compared the LipiFlow system with heated manual expression of the meibomian glands. Results demonstrated a statistically significant improvement (p<0.05) in meibomian gland secretion scores, tear break‑up time, corneal staining score and patient‑reported symptom scores for people suffering with meibomian gland dysfunction over 3 month follow‑up in those who used the LipiFlow system.

  • Three adverse events were reported in the clinical feasibility study, although they were all resolved without long‑term harm.

Technical factors

  • The system uses a standard AC power supply and is run from a table‑top console.

  • Heat is delivered from the lid warmer to the eyelids at a temperature of 42.5°C. The treatment must be delivered to both the top and bottom eyelids of each eye simultaneously.

  • Treatment can be given to 1 eye at a time or both eyes simultaneously.

Cost and resource use

  • No publicly available reports were identified about the resource consequences of adopting the LipiFlow system for obstructed meibomian glands.

  • The LipiFlow system costs £35,500. The single‑use, single‑eye activators are sold in packs of 10 that cost £2250 each. Annual software upgrades and servicing cost £5000 per year (all prices exclude VAT).