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

NASuspendedINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

December 1, 2023

Study Completion Date

December 1, 2023

Conditions
Corneal Thickness MeasurementEpithelial Thickness MeasurementLASIK Flap Thickness MeasurementSMILE Cap Thickness Measurement
Interventions
DEVICE

ArcScan Insight 100 very high-frequency digital ultrasound

The ArcScan Insight 100 VHF digital ultrasound scanner can measure individual layers within the cornea with very high precision, as well as being able to image the interior of the eye including the chamber between the iris and the cornea, the lens and other structures behind the iris. The ArcScan Insight 100 device is a digital ultrasound scanner, meaning that it uses ultrasound waves to measure parameters of the eye. The Insight examination involves the patient sitting in front of the ultrasound unit and looking through a disposable goggle-like eyepiece at a light source. Warm sterile balanced saline solution (like natural tears) are used to fill the space between the light source and the eye, to allow ultrasound transmission. There is no contact between the instrument and the eye other than being immersed in this water bath.

DEVICE

Carl Zeiss Meditec Cirrus HD OCT 5000

The Cirrus HD OCT 5000 uses high definition spectral domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them.

DEVICE

Optovue RTVue OCT

The Optovue RTVue OCT uses high definition Fourier/spectral domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them.

DEVICE

CSO MS-39 OCT

"The CSO MS-39 OCT uses high definition Fourier domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. The MS-39 also includes a Placido topographer within the device to simultaneously obtain a measurement of the shape (curvature) of the front surface of the cornea, which is then combined with the OCT thickness measurement to generate the shape of the back surface of the cornea.~An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them."

Trial Locations (1)

W1G 7LA

London Vision Clinic, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Carl Zeiss Meditec AG

INDUSTRY

lead

London Vision Clinic

OTHER

NCT03473847 - Repeatability, Reproducibility and Comparison of Cirrus OCT, RTVue OCT, MS-39 OCT, and Insight 100 VHFDU | Biotech Hunter | Biotech Hunter