Comparison of Cirrus OCT, RTVue OCT, MS-39 OCT and Insight 100 VHFDU

  • Research type

    Research Study

  • Full title

    Repeatability and reproducibility of Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT and ArcScan Insight 100 very high-frequency digital ultrasound and comparison between devices

  • IRAS ID

    252319

  • Contact name

    Mary Durbin

  • Contact email

    mary.durbin@zeiss.com

  • Sponsor organisation

    Carl Zeiss Meditec

  • Clinicaltrials.gov Identifier

    NCT03473847

  • Duration of Study in the UK

    1 years, 0 months, 6 days

  • Research summary

    Accurate and repeatable measurements of the thickness of the cornea (the clear window at the front of the eye) are of great importance for many applications in ophthalmology, and for laser refractive surgery in particular. Recently, it has also become apparent that measuring the thickness of the corneal epithelium (the layer of skin on the surface of the cornea) is useful for screening before surgery and monitoring healing after surgery. The ability to image and measure the interfaces created within the cornea in a laser refractive surgery procedure is also important for monitoring safety and planning further treatments.

    These measurements can be obtained either by very high-frequency (VHF) digital ultrasound or optical coherence tomography (OCT). VHF digital ultrasound has been used for this purpose for over 25 years, while OCT has been used for over 15 years. Recently, new versions of these devices have become available that have either improved or added the ability to measure epithelial thickness and interfaces within the cornea. These devices include the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT.

    This study aims to evaluate the precision (repeatability and reproducibility) of these four devices and compare the measurements between devices. Specifically, the aims of the study are:
    1) To report the repeatability and reproducibility of each device to understand the overall precision and therefore which applications each device can be reliably used for.
    2) To report the comparison between each pair of devices to understand whether thickness measurements can be used interchangeably. This may be either within an individual patient who has been scanned on different devices at different time points, or to evaluate the results of studies where different devices have been used.
    3) To investigate whether there was a systematic difference between VHF digital ultrasound and OCT measurements.

  • REC name

    London - Harrow Research Ethics Committee

  • REC reference

    18/LO/1469

  • Date of REC Opinion

    21 Dec 2018

  • REC opinion

    Further Information Favourable Opinion