Corneal Thickness MeasurementNCT03473847
Repeatability, Reproducibility and Comparison of Cirrus OCT, RTVue OCT, MS-39 OCT, and Insight 100 VHFDU
A study testing ArcScan Insight 100 very high-frequency digital ultrasound, Carl Zeiss Meditec Cirrus HD OCT 5000 and Optovue RTVue OCT in people with Corneal Thickness Measurement and Epithelial Thickness Measurement, run by London Vision Clinic at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the repeatability and reproducibility of corneal, epithelial, and LASIK flap thickness using the Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT, and ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Thickness Measurement, Epithelial Thickness Measurement, LASIK Flap Thickness Measurement
- What is being tested?
- ArcScan Insight 100 very high-frequency digital ultrasound, Carl Zeiss Meditec Cirrus HD OCT 5000 and Optovue RTVue OCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The purpose of this study is to evaluate the repeatability and reproducibility of corneal, epithelial, and LASIK flap thickness using the Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT, and ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner.
Read the 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.
- Conditions
- Corneal Thickness Measurement, Epithelial Thickness Measurement, LASIK Flap Thickness Measurement, SMILE Cap Thickness Measurement
- Being tested
- ArcScan Insight 100 very high-frequency digital ultrasound, Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT
- Keywords
- VHF digital ultrasound, Optical coherence tomography, Corneal thickness, Epithelial thickness, LASIK, SMILE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArcScan Insight 100 very high-frequency digital ultrasoundDevice
Also called Artemis 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.
Carl Zeiss Meditec Cirrus HD OCT 5000Device
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.
Optovue RTVue OCTDevice
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.
CSO MS-39 OCTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Repeatability and Reproducibility - Normal eyes | Experimental | 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:
1. 5 consecutive repeated scans of the cornea will be performed by the first operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set).
2. There will be a break of about 30 minutes.
3. 5 consecutive repeated scans of the cornea will be performed by the second operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set). Receives: Device: ArcScan Insight 100 very high-frequency digital ultrasound; Device: Carl Zeiss Meditec Cirrus HD OCT 5000; Device: Optovue RTVue OCT; Device: CSO MS-39 OCT |
| Repeatability and Reproducibility - Post-op eyes | Experimental | 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:
1. 5 consecutive repeated scans of the cornea will be performed by the first operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set).
2. There will be a break of about 30 minutes.
3. 5 consecutive repeated scans of the cornea will be performed by the second operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set). Receives: Device: ArcScan Insight 100 very high-frequency digital ultrasound; Device: Carl Zeiss Meditec Cirrus HD OCT 5000; Device: Optovue RTVue OCT; Device: CSO MS-39 OCT |
| Comparison between devices - Normal eyes | Experimental | 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. Receives: Device: ArcScan Insight 100 very high-frequency digital ultrasound; Device: Carl Zeiss Meditec Cirrus HD OCT 5000; Device: Optovue RTVue OCT; Device: CSO MS-39 OCT |
| Comparison between devices - Post-op eyes | Experimental | 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. Receives: Device: ArcScan Insight 100 very high-frequency digital ultrasound; Device: Carl Zeiss Meditec Cirrus HD OCT 5000; Device: Optovue RTVue OCT; Device: CSO MS-39 OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability and reproducibility of Cirrus HD OCT 5000 corneal scans in normal eyes (standard deviation)
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
Measured: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of RTVue OCT corneal scans in normal eyes (standard deviation)
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
Measured: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of MS-39 OCT corneal scans in normal eyes (standard deviation)
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
Measured: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of Insight 100 VHF digital ultrasound corneal scans in normal eyes (standard deviation)
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
Measured: 30 minutes (15 minutes per observer)
Repeatability and reproducibility of Cirrus HD OCT 5000 corneal scans in post-op eyes (standard deviation)
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
Measured: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of RTVue OCT corneal scans in post-op eyes (standard deviation)
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
Measured: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of MS-39 OCT corneal scans in post-op eyes (standard deviation)
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
Measured: 10 minutes (5 minutes per observer)
Repeatability and reproducibility of Insight 100 VHF digital ultrasound corneal scans in post-op eyes (standard deviation)
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
Measured: 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
The difference between each pair of devices for measurements of corneal thickness and epithelial thickness in eyes with no previous ocular surgery.
Measured: 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
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
Measured: 20 minutes for all four scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Sep 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: Devices currently awaiting software updates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Corneal Thickness MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Scans from 4 devices obtained on the same patient population for comparison
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Vision Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Carl Zeiss Meditec AG
- Responsible party
- Sponsor
- Investigators
- Dan Z Reinstein, MD, MA, FRCOphth, Principal investigator, London Vision Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473847
- Sponsor's protocol ID
- LOVC-006
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2018
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No data will be shared with other researchers
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.
PubMed 19928698Reinstein 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.
PubMed 26186562Yap 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.
PubMed 26856428Kiraly 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.
PubMed 28357136
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03473847
- Acronym / sponsor ID
- LOVC-006
- Conditions
- Corneal Thickness Measurement, Epithelial Thickness Measurement, LASIK Flap Thickness Measurement, SMILE Cap Thickness Measurement
- Keywords
- VHF digital ultrasound, Optical coherence tomography, Corneal thickness, Epithelial thickness, LASIK, SMILE
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Devices currently awaiting software updates
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- London Vision ClinicUniversity, hospital or other
- Collaborators
- Carl Zeiss Meditec AG
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the repeatability and reproducibility of corneal, epithelial, and LASIK flap thickness using the Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT, and ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Scans from 4 devices obtained on the same patient population for comparison
| Arm | Type | Receives |
|---|---|---|
| Repeatability and Reproducibility - Normal eyes | Experimental | Device: ArcScan Insight 100 very high-frequency digital ultrasound, Device: Carl Zeiss Meditec Cirrus HD OCT 5000, Device: Optovue RTVue OCT, Device: CSO MS-39 OCTThis 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: 1. 5 consecutive repeated scans of the cornea will be performed by the first operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set). 2. There will be a break of about 30 minutes. 3. 5 consecutive repeated scans of the cornea will be performed by the second operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set). |
| Repeatability and Reproducibility - Post-op eyes | Experimental | Device: ArcScan Insight 100 very high-frequency digital ultrasound, Device: Carl Zeiss Meditec Cirrus HD OCT 5000, Device: Optovue RTVue OCT, Device: CSO MS-39 OCTThis 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: 1. 5 consecutive repeated scans of the cornea will be performed by the first operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set). 2. There will be a break of about 30 minutes. 3. 5 consecutive repeated scans of the cornea will be performed by the second operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set). |
| Comparison between devices - Normal eyes | Experimental | Device: ArcScan Insight 100 very high-frequency digital ultrasound, Device: Carl Zeiss Meditec Cirrus HD OCT 5000, Device: Optovue RTVue OCT, Device: CSO MS-39 OCTThis 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. |
| Comparison between devices - Post-op eyes | Experimental | Device: ArcScan Insight 100 very high-frequency digital ultrasound, Device: Carl Zeiss Meditec Cirrus HD OCT 5000, Device: Optovue RTVue OCT, Device: CSO MS-39 OCTThis 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Only patients who are medically suitable for corneal laser refractive surgery can be included in the study.
- 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.
- Eyes with no ocular pathology
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArcScan Insight 100 very high-frequency digital ultrasoundAlso: Artemis very high-frequency digital ultrasoundThe 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 | Comparison between devices - Normal eyes, Comparison between devices - Post-op eyes, Repeatability and Reproducibility - Normal eyes, Repeatability and Reproducibility - Post-op eyes |
| Carl Zeiss Meditec Cirrus HD OCT 5000The 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 | Comparison between devices - Normal eyes, Comparison between devices - Post-op eyes, Repeatability and Reproducibility - Normal eyes, Repeatability and Reproducibility - Post-op eyes |
| Optovue RTVue OCTThe 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 | Comparison between devices - Normal eyes, Comparison between devices - Post-op eyes, Repeatability and Reproducibility - Normal eyes, Repeatability and Reproducibility - Post-op eyes |
| CSO MS-39 OCTThe 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. | Device | Comparison between devices - Normal eyes, Comparison between devices - Post-op eyes, Repeatability and Reproducibility - Normal eyes, Repeatability and Reproducibility - Post-op eyes |
Primary outcome
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
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
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
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
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
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
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
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
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Background: PubMed 19928698Reinstein 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.
- Background: PubMed 26186562Reinstein 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.
- Background: PubMed 26856428Yap 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.
- Background: PubMed 28357136Kiraly 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.
- Individual participant dataSharing planned: No. No data will be shared with other researchers
Related trials for Corneal Thickness Measurement
Not yet recruitingObservational study
Thick Cornea with High Back Elevation
Corneal Thickness Measurement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Z Reinstein, MD, MA, FRCOphth principal investigator
London Vision Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArcScan Insight 100 very high-frequency digital ultrasound, Carl Zeiss Meditec Cirrus HD OCT 5000 and Optovue RTVue OCT in people with Corneal Thickness Measurement and Epithelial Thickness Measurement, run by London Vision Clinic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeatability and reproducibility of Cirrus HD OCT 5000 corneal scans in normal eyes (standard deviation) (time frame: 10 minutes (5 minutes per observer)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03473847, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.