Summary

Summary

The SENSIMED Triggerfish is a contact lens sensor that continuously measures changes in ocular dimensions, which are related to changes in intraocular pressure (IOP, or pressure in the eye). It is designed to record patterns of IOP-related changes over 24 hours, and is intended to be used in people with or at risk of glaucoma.

Effectiveness

  • Thirteen publications were identified involving a total of 237 patients (from 5 patients in the smallest to 40 in the largest). Of these studies, 9 were observational, 2 were interventional, and 1 was a trial register record.

  • No studies were identified showing agreement with a reference standard for monitoring IOP, or which included clinical efficacy outcomes.

  • There is uncertainty about how well dimensional changes measured by the SENSIMED Triggerfish reflect true fluctuations in IOP.

  • No evidence was identified to show that 24‑hour recording with the SENSIMED Triggerfish leads to improved clinical outcomes for patients, such as control of IOP, progression from ocular hypertension (OHT) to glaucoma, or vision loss. One study reported that therapy was changed in 11 patients (73%) following results of 24‑hour recording with the SENSIMED Triggerfish.

Adverse events and safety

  • Of the 13 studies included in the analysis, 10 reported mild or moderate adverse events and 2 reported severe adverse events. Device-related adverse events tended to resolve quickly.

  • Patient comfort or tolerability was reported in 5 studies and found to be good. Poor tolerability of the device resulted in incomplete monitoring with the SENSIMED Triggerfish in 4 people out of the 63 people taking part in 3 of these studies.

Cost and resource use

  • Initial outlay for the SENSIMED Triggerfish system is approximately £5923 for hardware and software. Each use of the device is estimated to cost £424–£549 in single-use consumables, plus clinician time.

  • The SENSIMED Triggerfish sensor is fitted and removed by an ophthalmologist or appropriately trained optometrist. The results must be separately analysed and interpreted.

  • There is no published evidence reporting cost or resource use.

Technical factors

  • The SENSIMED Triggerfish measures ocular dimensional changes captured at the corneoscleral junction area. The device uses this information to produce a qualitative profile of relative IOP-related peaks and patterns over 24 hours.

  • The SENSIMED Triggerfish measures ocular dimensional patterns in electrical units (millivolts), which cannot be directly compared with conventional IOP measurement devices such as Goldmann Applanation Tonometry (GAT).

  • The patient wears the device for 24 hours while they go about usual activities (with some exceptions such as while showering, swimming or driving).