- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03473847
Repeatability, Reproducibility and Comparison of Cirrus OCT, RTVue OCT, MS-39 OCT, and Insight 100 VHFDU
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
Study Overview
Status
Conditions
Detailed Description
Very high-frequency (VHF) digital ultrasound was first used in 1993 to obtain images and measure the thickness of the cornea (the window at the front of the eye) and the layers within the cornea, such as the epithelium (the layer of skin on the surface of the cornea). A commercially available instrument, known as the Artemis, has been used in routine clinical practice since 2001. The ArcScan Insight 100 VHF digital ultrasound scanner is an updated version, which obtained CE mark in 2016.
Optical coherence tomography (OCT) is another method of measuring the thickness of the cornea and the corneal epithelium. OCT has been used for measuring corneal thickness since 1997 and the technology had evolved to also measure epithelial thickness since 2012. There are currently three OCT scanners capable of measuring epithelial thickness; Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT.
The aim of the study is to establish the repeatability (i.e. the variability in measurements taken by a single examiner during a single visit) and reproducibility (i.e. the variability in measurements taken in the same conditions between two examiners) for each of the four devices for measuring corneal thickness and epithelial thickness.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom, W1G 7LA
- London Vision Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Only patients who are medically suitable for corneal laser refractive surgery can be included in the study.
As general inclusion criteria the following aspects are defined:
- Subjects should be 21 years of age or older.
- Contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses.
- Patient will be able to understand the patient information and willing to sign an informed consent.
For the normal eye populations:
- Eyes with no ocular pathology
- Eyes with no previous ocular or corneal surgery
For the post-op eye populations:
• Eyes between 3 and 9 months after LASIK or SMILE
Exclusion Criteria:
- Previous ocular or corneal surgery (for normal eyes)
- Patient not being able to tolerate local or topical anesthesia
- Patient has active conjunctivitis or any active ocular infection or inflammation
- Patient has a corneal ulcer
- Patient has an open wound on the corneal epithelium
- Patient has compromised epithelium (e.g. ≥Grade 3 superficial punctate keratitis)
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Repeatability and Reproducibility - Normal eyes
This arm will include 20 eyes of 20 patients with no previous ocular surgery. The research participant will be scanned a number of times using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). The scan sequence will be undertaken on a single day as follows:
|
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.
Other Names:
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.
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.
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. |
Experimental: Repeatability and Reproducibility - Post-op eyes
This arm will include 20 eyes of 20 patients between 3 and 9 months after corneal laser refractive surgery. The research participant will be scanned a number of times using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). The scan sequence will be undertaken on a single day as follows:
|
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.
Other Names:
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.
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.
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. |
Experimental: Comparison between devices - Normal eyes
This arm will include 101 eyes of 101 patients with no previous ocular surgery. The research participant will be scanned once using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). Expected total time approximately 20 minutes to complete all four scans. |
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.
Other Names:
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.
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.
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. |
Experimental: Comparison between devices - Post-op eyes
This arm will include 101 eyes of 101 patients between 3 and 9 months after corneal laser refractive surgery. The research participant will be scanned once using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). Expected total time approximately 20 minutes to complete all four scans. |
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.
Other Names:
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.
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.
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Repeatability and reproducibility of Cirrus HD OCT 5000 corneal scans in normal eyes (standard deviation)
Time Frame: 10 minutes (5 minutes per observer)
|
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery
|
10 minutes (5 minutes per observer)
|
Repeatability and reproducibility of RTVue OCT corneal scans in normal eyes (standard deviation)
Time Frame: 10 minutes (5 minutes per observer)
|
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery
|
10 minutes (5 minutes per observer)
|
Repeatability and reproducibility of MS-39 OCT corneal scans in normal eyes (standard deviation)
Time Frame: 10 minutes (5 minutes per observer)
|
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery
|
10 minutes (5 minutes per observer)
|
Repeatability and reproducibility of Insight 100 VHF digital ultrasound corneal scans in normal eyes (standard deviation)
Time Frame: 30 minutes (15 minutes per observer)
|
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery
|
30 minutes (15 minutes per observer)
|
Repeatability and reproducibility of Cirrus HD OCT 5000 corneal scans in post-op eyes (standard deviation)
Time Frame: 10 minutes (5 minutes per observer)
|
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery
|
10 minutes (5 minutes per observer)
|
Repeatability and reproducibility of RTVue OCT corneal scans in post-op eyes (standard deviation)
Time Frame: 10 minutes (5 minutes per observer)
|
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery
|
10 minutes (5 minutes per observer)
|
Repeatability and reproducibility of MS-39 OCT corneal scans in post-op eyes (standard deviation)
Time Frame: 10 minutes (5 minutes per observer)
|
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery
|
10 minutes (5 minutes per observer)
|
Repeatability and reproducibility of Insight 100 VHF digital ultrasound corneal scans in post-op eyes (standard deviation)
Time Frame: 30 minutes (15 minutes per observer)
|
The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery
|
30 minutes (15 minutes per observer)
|
Difference in corneal thickness measurements between Cirrus HD OCT 5000, RTVue OCT, MS-39 OCT, and Insight 100 VHF digital ultrasound in normal eyes
Time Frame: 20 minutes for all four scans
|
The difference between each pair of devices for measurements of corneal thickness and epithelial thickness in eyes with no previous ocular surgery.
|
20 minutes for all four scans
|
Difference in corneal thickness measurements between Cirrus HD OCT 5000, RTVue OCT, MS-39 OCT, and Insight 100 VHF digital ultrasound in post-op eyes
Time Frame: 20 minutes for all four scans
|
The difference between each pair of devices for corneal thickness, epithelial thickness and interface thickness in eyes between 3 and 9 months after corneal laser refractive surgery
|
20 minutes for all four scans
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dan Z Reinstein, MD, MA, FRCOphth, London Vision Clinic
Publications and helpful links
General Publications
- Reinstein DZ, Archer TJ, Gobbe M, Silverman RH, Coleman DJ. Repeatability of layered corneal pachymetry with the artemis very high-frequency digital ultrasound arc-scanner. J Refract Surg. 2010 Sep;26(9):646-59. doi: 10.3928/1081597X-20091105-01. Epub 2009 Nov 16.
- Reinstein DZ, Yap TE, Archer TJ, Gobbe M, Silverman RH. Comparison of Corneal Epithelial Thickness Measurement Between Fourier-Domain OCT and Very High-Frequency Digital Ultrasound. J Refract Surg. 2015 Jul;31(7):438-45. doi: 10.3928/1081597X-20150623-01.
- Yap TE, Archer TJ, Gobbe M, Reinstein DZ. Comparison of Central Corneal Thickness Between Fourier-Domain OCT, Very High-Frequency Digital Ultrasound, and Scheimpflug Imaging Systems. J Refract Surg. 2016 Feb;32(2):110-6. doi: 10.3928/1081597X-20151223-01.
- Kiraly L, Stange J, Kunert KS, Sel S. Repeatability and Agreement of Central Corneal Thickness and Keratometry Measurements between Four Different Devices. J Ophthalmol. 2017;2017:6181405. doi: 10.1155/2017/6181405. Epub 2017 Mar 5.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LOVC-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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