Corneal Thickness MeasurementNCT02519985
Repeatability and Reproducibility of the ArcScan Insight 100 VHF Digital Ultrasound
A study testing ArcScan Insight 100 very high-frequency digital ultrasound 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 (including corneal, epithelial, stromal, and LASIK flap thickness) and anterior segment measurements using the ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Thickness Measurement, Epithelial Thickness Measurement, Anterior Eye Segment Measurements
- What is being tested?
- ArcScan Insight 100 very high-frequency digital ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2016to 31 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
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 Corneal and Anterior Segment Measurements by ArcScan Insight 100 Very High-frequency Digital Ultrasound
The purpose of this study is to evaluate the repeatability and reproducibility of corneal (including corneal, epithelial, stromal, and LASIK flap thickness) and anterior segment measurements using the 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 of the cornea (the window at the front of the eye) and anterior segment (the space behind the cornea including the iris and the lens). A commercially available instrument, called the Artemis 2, has been used in routine clinical practice since 2001. The Artemis 2 was CE approved as well as having FDA approval (the US equivalent of the CE mark).
The ArcScan Insight 100 VHF digital ultrasound scanner is a new instrument so does not yet have a CE mark. However, the ArcScan Insight 100 is an upgraded version of the Artemis 2, so any differences are improvements to components, but the measurement method remains essentially the same.
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) of the ArcScan Insight 100 device for measuring corneal and anterior segment parameters.
- Conditions
- Corneal Thickness Measurement, Epithelial Thickness Measurement, Anterior Eye Segment Measurements
- Being tested
- ArcScan Insight 100 very high-frequency digital ultrasound
- Keywords
- VHF digital ultrasound, Corneal thickness, Epithelial thickness, Angle diameter, Sulcus diameter, Anterior chamber depth, Repeatability, Reproducibility
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 VHF digital ultrasound
The ArcScan Insight 100 VHF digital ultrasound scanner that 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.
| Study group | Role | What they receive |
|---|---|---|
| Repeatability and Reproducibility of ArcScan Insight 100 | Experimental | For repeatability and reproducibility in normal eyes (n=20):
Firstly, 5 consecutive repeated ArcScan Insight 100 scans of the cornea and anterior segment will be performed by the first operator.
After a break of about 30 minutes, 5 consecutive repeated ArcScan Insight 100 scans of the cornea and anterior segment will be performed by the second operator.
For repeatability and reproducibility in eyes after laser refractive surgery (n=20):
Firstly, 5 consecutive repeated ArcScan Insight 100 scans of the cornea will be performed by the first operator.
After a break of about 30 minutes, 5 consecutive repeated ArcScan Insight 100 scans of the cornea will be performed by the second operator. Receives: Device: ArcScan Insight 100 very high-frequency digital ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability of ArcScan Insight 100 corneal scans in normal eyes (standard deviation)
The standard deviation of 5 repeated measurements for corneal thickness, epithelial thickness, and stromal thickness in normal eyes with no previous corneal surgery
Measured: 1 day
Secondary outcomes (5)
Reproducibility of ArcScan Insight 100 corneal scans in normal eyes (between-operator standard deviation)
The between-operator standard deviation of 5 repeated measurements for each operator for corneal thickness, epithelial thickness, and stromal thickness in normal eyes with no previous corneal surgery
Measured: 1 day
Repeatability of ArcScan Insight 100 anterior segment scans in normal eyes (standard deviation)
The standard deviation of 5 repeated measurements for anterior segment dimensions: angle diameter, sulcus diameter, anterior chamber depth, and lens rise from the zonular plane in normal eyes with no previous corneal surgery
Measured: 1 day
Reproducibility of ArcScan Insight 100 anterior segment scans in normal eyes (between-operator standard deviation)
The between-operator standard deviation of 5 repeated measurements for each operator for anterior segment dimensions: angle diameter, sulcus diameter, anterior chamber depth, and lens rise from the zonular plane in normal eyes with no previous corneal surgery
Measured: 1 day
Repeatability of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (standard deviation)
The standard deviation of 5 repeated measurements for corneal thickness, epithelial thickness, stromal thickness, flap thickness, and residual stromal thickness in eyes after corneal laser refractive surgery
Measured: 1 day
Reproducibility of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (between-operator standard deviation)
The between-operator standard deviation of 5 repeated measurements for each operator for corneal thickness, epithelial thickness, stromal thickness, flap thickness, and residual stromal thickness in eyes after corneal laser refractive surgery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study start1 Nov 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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 (5)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Vision Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Arcscan, Inc.
- Responsible party
- Principal investigator, Dan Reinstein, London Vision Clinic
- Investigators
- Dan Z Reinstein, MD MA, Principal investigator, London Vision Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519985
- Sponsor's protocol ID
- LoVC-005
- Status last verified
- Dec 2023
- First submitted
- 7 Aug 2015
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reinstein DZ, Silverman RH, Raevsky T, Simoni GJ, Lloyd HO, Najafi DJ, Rondeau MJ, Coleman DJ. Arc-scanning very high-frequency digital ultrasound for 3D pachymetric mapping of the corneal epithelium and stroma in laser in situ keratomileusis. J Refract Surg. 2000 Jul-Aug;16(4):414-30. doi: 10.3928/1081-597X-20000701-04.
PubMed 10939721Paul T, Lim M, Starr CE, Lloyd HO, Coleman DJ, Silverman RH. Central corneal thickness measured by the Orbscan II system, contact ultrasound pachymetry, and the Artemis 2 system. J Cataract Refract Surg. 2008 Nov;34(11):1906-12. doi: 10.1016/j.jcrs.2008.07.013.
PubMed 19006737Ursea R, Feng M, Urs R, RoyChoudhury A, Silverman RH. Comparison of artemis 2 ultrasound and Visante optical coherence tomography corneal thickness profiles. J Refract Surg. 2013 Jan;29(1):36-41. doi: 10.3928/1081597X-20121126-01. Epub 2012 Nov 30.
PubMed 23205905Ogbuehi KC, Osuagwu UL. Repeatability and interobserver reproducibility of Artemis-2 high-frequency ultrasound in determination of human corneal thickness. Clin Ophthalmol. 2012;6:761-9. doi: 10.2147/OPTH.S31690. Epub 2012 May 21.
PubMed 22693418Pinero DP, Plaza AB, Alio JL. Anterior segment biometry with 2 imaging technologies: very-high-frequency ultrasound scanning versus optical coherence tomography. J Cataract Refract Surg. 2008 Jan;34(1):95-102. doi: 10.1016/j.jcrs.2007.08.033.
PubMed 18165088
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability and Reproducibility of Corneal and Anterior Segment Measurements by ArcScan Insight 100 Very High-frequency Digital Ultrasound
- ClinicalTrials.gov ID
- NCT02519985
- Acronym / sponsor ID
- LoVC-005
- Conditions
- Corneal Thickness Measurement, Epithelial Thickness Measurement, Anterior Eye Segment Measurements
- Keywords
- VHF digital ultrasound, Corneal thickness, Epithelial thickness, Angle diameter, Sulcus diameter, Anterior chamber depth, Repeatability, Reproducibility
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Devices currently awaiting software updates
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- London Vision ClinicUniversity, hospital or other
- Collaborators
- Arcscan, Inc.
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Aug 2015 (estimated)
- 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 (including corneal, epithelial, stromal, and LASIK flap thickness) and anterior segment measurements using the 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 of the cornea (the window at the front of the eye) and anterior segment (the space behind the cornea including the iris and the lens). A commercially available instrument, called the Artemis 2, has been used in routine clinical practice since 2001. The Artemis 2 was CE approved as well as having FDA approval (the US equivalent of the CE mark).
The ArcScan Insight 100 VHF digital ultrasound scanner is a new instrument so does not yet have a CE mark. However, the ArcScan Insight 100 is an upgraded version of the Artemis 2, so any differences are improvements to components, but the measurement method remains essentially the same.
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) of the ArcScan Insight 100 device for measuring corneal and anterior segment parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repeatability and Reproducibility of ArcScan Insight 100 | Experimental | Device: ArcScan Insight 100 very high-frequency digital ultrasoundFor repeatability and reproducibility in normal eyes (n=20): Firstly, 5 consecutive repeated ArcScan Insight 100 scans of the cornea and anterior segment will be performed by the first operator. After a break of about 30 minutes, 5 consecutive repeated ArcScan Insight 100 scans of the cornea and anterior segment will be performed by the second operator. For repeatability and reproducibility in eyes after laser refractive surgery (n=20): Firstly, 5 consecutive repeated ArcScan Insight 100 scans of the cornea will be performed by the first operator. After a break of about 30 minutes, 5 consecutive repeated ArcScan Insight 100 scans of the cornea will be performed by the second operator. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
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: VHF digital ultrasoundThe ArcScan Insight 100 VHF digital ultrasound scanner that 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 | Repeatability and Reproducibility of ArcScan Insight 100 |
Primary outcome
Repeatability of ArcScan Insight 100 corneal scans in normal eyes (standard deviation)
Time frame: 1 day
The standard deviation of 5 repeated measurements for corneal thickness, epithelial thickness, and stromal thickness in normal eyes with no previous corneal surgery
5 secondary outcomes
Reproducibility of ArcScan Insight 100 corneal scans in normal eyes (between-operator standard deviation)
Time frame: 1 day
Repeatability of ArcScan Insight 100 anterior segment scans in normal eyes (standard deviation)
Time frame: 1 day
Reproducibility of ArcScan Insight 100 anterior segment scans in normal eyes (between-operator standard deviation)
Time frame: 1 day
Repeatability of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (standard deviation)
Time frame: 1 day
Reproducibility of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (between-operator standard deviation)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 10939721Reinstein DZ, Silverman RH, Raevsky T, Simoni GJ, Lloyd HO, Najafi DJ, Rondeau MJ, Coleman DJ. Arc-scanning very high-frequency digital ultrasound for 3D pachymetric mapping of the corneal epithelium and stroma in laser in situ keratomileusis. J Refract Surg. 2000 Jul-Aug;16(4):414-30. doi: 10.3928/1081-597X-20000701-04.
- Background: PubMed 19006737Paul T, Lim M, Starr CE, Lloyd HO, Coleman DJ, Silverman RH. Central corneal thickness measured by the Orbscan II system, contact ultrasound pachymetry, and the Artemis 2 system. J Cataract Refract Surg. 2008 Nov;34(11):1906-12. doi: 10.1016/j.jcrs.2008.07.013.
- Background: PubMed 23205905Ursea R, Feng M, Urs R, RoyChoudhury A, Silverman RH. Comparison of artemis 2 ultrasound and Visante optical coherence tomography corneal thickness profiles. J Refract Surg. 2013 Jan;29(1):36-41. doi: 10.3928/1081597X-20121126-01. Epub 2012 Nov 30.
- Background: PubMed 22693418Ogbuehi KC, Osuagwu UL. Repeatability and interobserver reproducibility of Artemis-2 high-frequency ultrasound in determination of human corneal thickness. Clin Ophthalmol. 2012;6:761-9. doi: 10.2147/OPTH.S31690. Epub 2012 May 21.
- Background: PubMed 18165088Pinero DP, Plaza AB, Alio JL. Anterior segment biometry with 2 imaging technologies: very-high-frequency ultrasound scanning versus optical coherence tomography. J Cataract Refract Surg. 2008 Jan;34(1):95-102. doi: 10.1016/j.jcrs.2007.08.033.
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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 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 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 0 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 11 Dec 2023. 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 of ArcScan Insight 100 corneal scans in normal eyes (standard deviation) (time frame: 1 day). 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 NCT02519985, which also lists 5 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 11 Dec 2023.