Advice

Technology overview

Technology overview

This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.

About the technology

CE marking

The LipiFlow system was CE‑marked under the Medical Devices Directive 2007/47/EC in July 2011 as a Class IIa device.

Description

The LipiFlow system (TearScience) is a thermal pulsation system, which delivers heat at a temperature of 42.5°C to the inner eyelid, and pressure to the outer eyelid surfaces simultaneously. These actions are designed to loosen, liquefy and express hardened meibomian lipids that have blocked the meibomian glands.

The LipiFlow system consists of the control unit (non‑disposable component) and the single‑use disposable activator.

The control unit, known as the console (model LFTP‑1000), enables the user to regulate the application of heat and pressure to the eyelids. The console is a benchtop AC powered device, consisting of a touchscreen display with graphical user interface and patient database, the activator connection points (for either eye), a power cord connection (with a power switch) and 3 USB ports. As an optional extra, the touchscreen display can be mounted onto a pivoting arm, which allows the user to reposition the screen.

The activator is the only component that is in direct contact with the person during treatment. Two models of the activator are available:

  • Model LFD‑1000 is compatible with LipiFlow consoles operating any software version.

  • Model LFD‑1100 is compatible with LipiFlow consoles operating software versions 1.1 and above.

The activator is a single‑use eyepiece made of biocompatible polycarbonate and silicone. It is inserted around the person's eyelids and consists of 5 parts:

  • lid warmer

  • eye cup

  • handle

  • air and electrical tubing

  • electronic connection piece.

The lid warmer is a curved plastic cup, approximately 24 mm in diameter. It sits under the eyelids, on the eyeball. The surface of the lid warmer is silicone‑lined and this makes it soft and flexible. An electric temperature‑controlled heater is embedded in the convex surface of the lid warmer and transfers heat through the inner eyelids to the meibomian glands. The concave surface is insulated to protect the cornea from heat. The eye cup is connected to the lid warmer. It sits over the closed eyelids once the lid warmer is in place. Two inflatable bladders on the eye cup continually pressurise and depressurise, squeezing the meibomian glands against the lid warmer. Each treatment takes 12 minutes.

The handle aids the user in positioning the activator on the eye. One activator is needed for each eye, and the air and electrical tubing connect to separate ports on the console so that both eyes can be treated at the same time.

TearScience produce 2 other products that work with the LipiFlow system, which are beyond the scope of this briefing. These are:

  • LipiView, a Class IIb medical device

  • the Meibomian Gland Evaluator.

Intended use

The LipiFlow system is intended for use in adults with obstructive meibomian gland dysfunction, where terminal meibomian gland ducts are blocked and the glandular secretions cannot be drained.

TearScience list a number of contraindications and advise that the LipiFlow system should not be used in people who have, or have had, the following conditions or treatments:

  • Ocular surgery within the last 3 months.

  • Ocular injury within the last 3 months.

  • Ocular herpes within the last 3 months.

  • Active ocular infection.

  • Active ocular inflammation or history of chronic, recurrent ocular inflammation within the last 3 months.

  • Eyelid abnormalities that affect lid function.

  • Ocular surface abnormality that may compromise corneal integrity.

Setting and intended user

In current NHS eye care services, opticians, optometrists and ophthalmologists advise on eye care. Treatment at specialist eye departments and hospitals can be provided following a referral from a GP or optician (NHS Choices 2014b).

The LipiFlow system is intended to be used by optometrists in primary care, or by optometrists or ophthalmologists in secondary care ophthalmology departments or in tertiary care at specialist eye hospitals.

Current NHS options

The most likely current treatment for meibomian gland dysfunction (MGD) involves regular self‑administration of warm compresses and massage therapy to the eyelids. Commercially available eye pads or flannels can be warmed in water (or a microwave in some cases) and placed over closed eyes for short but regular periods of time. This action is intended to loosen the hardened lipids within the meibomian glands. Eyelid massage, using a finger or cotton wool bud, is then applied to force the lipids out of the meibomian glands, relieving the obstruction. Increased lid hygiene can also be used to aid removal of debris from the eyelids. This can involve washing the eyes in a weak solution of baby shampoo, tea tree shampoo or bicarbonate of soda dissolved in warm water (NHS Choices 2014c).

Generic dry eye treatments may also be prescribed to people with MGD to relieve discomfort. Examples include lubricants, which are intended to increase the aqueous layer in the tear film and keep the surface of the eye moist (NHS Choices 2014d). Oily tear drops and eye ointments, which increase the lipid layer in the tear film, may also provide relief from symptoms (NHS Choices 2014d). In addition, anti‑inflammatory medication to reduce pain caused by swelling of the eyelids can be prescribed (NHS Choices 2014d), as can topical or systemic antibiotics to treat infections. Eating a diet high in omega‑3 fatty acids may also help to improve dry eye symptoms (NHS Choices 2014c). However, these generic eye treatments do not treat the root cause of MGD as they do not loosen blockages in the meibomian glands.

In very rare circumstances, surgery may be offered to treat severe dry eye symptoms. Punctal occlusion involves the insertion of silicone plugs to block the tear ducts. This prevents the tears draining from the surface of the eye. If the plugs fail the tear ducts can be cauterised, permanently blocking the ducts to stop tears draining from the surface of the eye (NHS Choices 2014d). The final surgical option is salivary gland auto‑transplantation. The transplanted salivary gland produces fluid, which acts as a substitute for tears (NHS Choices 2014d).

NICE is aware of the following CE marked device that appears to fulfil a similar function to the LipiFlow system:

  • Blephasteam, Laboratoires Théa.

Costs and use of the technology

The capital component of the LipiFlow system, the console, costs £35,500 (excluding VAT), and has a lifespan of 3 years. The single‑use activators are sold in packs of 10 that cost £2250 each. Annual software upgrades, including servicing, cost £5000.

The treatment takes 12 minutes for either a single or bilateral eye treatment. If it is assumed that the procedure would take a total of 20 minutes (including set‑up time), then approximately 20 cases can be treated in a day.

Assuming that 20 treatments were done per day for 240 days per year, the overall equipment cost per treatment is estimated to be £228 per eye or £453 for both eyes. This assumes a standard annuity method with an equipment lifespan of 3 years and a discount rate of 3.5% (Drummond et al. 2005). Free on‑site user training is provided by the manufacturer.

The alternative treatment options are self‑administered warm compresses or lid massage, which incur only minimal equipment costs. Artificial tears used for relieving dry eye symptoms are available over the counter (price range £3–10). However, they are not considered as an alternative treatment to LipiFlow since they do not remove blockages from meibomian glands.

No other practical difficulties have been identified in using or adopting the technology.

Likely place in therapy

The LipiFlow system is not currently being offered within the NHS, although it is available for purchase in the UK. The LipiFlow system is currently only available in private clinics. If adopted within the NHS, the LipiFlow system would be used to treat people who have not responded to currently available treatments. These people are likely to be referred from their optician or GP to ophthalmologists for treatment with the LipiFlow system.

Specialist commentator comments

Two specialist commentators noted that the LipiFlow system is 1 of many treatment options intended to alleviate symptoms of dry eye in people with meibomian gland dysfunction (MGD). One commentator added that LipiFlow should only be used to treat people who have not responded to conservative treatment options, such as increased lid hygiene or lubricants. These people may benefit from treatment with the LipiFlow system, which could be considered before invasive surgical intervention.

One specialist commentator reflected that the LipiFlow system cannot treat symptoms caused by poor‑quality meibomian lipid secretions that tend to solidify at body temperature and so are prone to blocking the meibomian glands. These poor‑quality secretions can have underlying causes such as infection with Demodex parasites (eyelash mites), seborrhoeic conditions, or omega‑3 fatty acid deficiency. Therefore, the LipiFlow system should always be used in conjunction with other adjuvant therapies. This specialist felt that the LipiFlow system would be more beneficial to people with more acute and transient dry eye rather than those with chronic symptoms. People with chronic symptoms often have meibomian gland 'drop‑out', where the meibomian glands are partly or completely lost, so the LipiFlow system would be of little benefit to these people.

One specialist commentator noted that there are currently no published studies comparing use of the LipiFlow system with the standard therapies for MGDs, including omega‑3 supplements and systemic or topical antibiotics.

One specialist commentator felt that the LipiFlow system could be used to treat people whose meibomian secretions are cloudy and of poor quality. They speculated that LipiFlow treatment would be probably not be performed in specialist eye hospitals, as it is currently being performed by technicians. This commentator did not consider LipiFlow treatment to be a specialist procedure, and so in the NHS it would be more likely to be performed by trained ophthalmologists or nurses.

Equality considerations

NICE is committed to promoting equality and eliminating unlawful discrimination. We aim to comply fully with all legal obligations to:

  • promote race and disability equality and equality of opportunity between men and women, and

  • eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief, in the way we produce our guidance (these are protected characteristics under the Equality Act (2010).

TearScience state that the LipiFlow system is intended for use in adults, which therefore excludes children or young people from being treated with the device.

The reportedly high prevalence of meibomian gland dysfunction in people of Asian family origin compared with figures for people of white origin (Nichols et al. 2011) could mean that more people of Asian family origin are eligible for treatment with the LipiFlow System compared with the general population. Dry eye can impact upon all age groups, but it is more common in people aged over 65 years (NHS Choices 2014a). Age and race are protected characteristics defined in the Equality Act 2010.