CorneaNCT02293122
To Investigate Agreement Between the EM-3000 and the Predicate Device Noncon Robo Pachy (F&A) (CellChek XL)
An observational study of Cornea, run by Tomey Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the precision and agreement of the study device, a specular microscope, in comparison to a currently commercially available specular microscope in establishing substantial equivalence of the two devices in clinical use for diagnostic purposes of the human cornea. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cornea
- What is being tested?
- Observational
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jul 2015
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study plan calls for 75 subjects divided into three sub-groups, young healthy (18-50 yrs), older healthy (51-80 yrs), and pathologic adults (29-80 years).
Who may be able to join
- Eyes with one of the following corneal conditions:
- Non-pathologic younger eyes (18-50 yrs) Non-pathologic older eyes (51-80 yrs) Pathologic adult eyes (29-80)
Who cannot join
- Seriously ill or unconscious subject, mentally ill person, mentally handicapped person, person who is unable to read or write.
- Non-Pathologic subjects who have the following conditions :
- History of corneal transplant
- Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
- Guttata
- History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device
Show all 9Show fewer
- Long term PMMA contact lens use longer than 5 years
- -Pathologic subjects
- Keratoconus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Investigate Agreement Between the EM-3000 and the Predicate Device NonCon Robo Pachy (F&A) (CellChek XL).
The purpose of this study is to evaluate the precision and agreement of the study device, a specular microscope, in comparison to a currently commercially available specular microscope in establishing substantial equivalence of the two devices in clinical use for diagnostic purposes of the human cornea.
Read the detailed description
The observational clinical investigation is intended to measure agreement between two diagnostic instruments of the eye's corneal endothelium. The study device is the EM-3000 specular microscope and the control device is the NonCon Robo Pachy (F\&A) (CellChek XL) specular microscope. Both instruments measure corneal endothelial cell layer parameters including cell density, coefficient of variation, percent hexagonality, and central thickness.
The primary variable is the measurement of agreement between the two instruments for the four parameters described. The secondary variables include repeatability (intra-investigator) and reproducibility both inter-investigator, and inter-instrument.
Additionally, measurements of agreement will be made on the EM-3000 using automated analysis with and without touch-up.
- Conditions
- Cornea
- Being tested
- Observational
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Intervention is observational to two different diagnostic devices for which comparative readings of the corneal endothelium are being measured; the test device- the EM-3000 Specular Microscope against the Konan Robo-pachy F\&A Specular Microscope.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Observational group exposure to three test devices and one comparative device. The test Konan Non-con Robo Pachy F\&A Specular Microscope. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between EM-3000 and NonCon Robo Pachy F&A (CellChek XL)
For Agreement between the two instruments, outcome measures include endothelial cell density (/mm2), coefficient of variation between the two instruments (SD x CD x 10-6, and percent hexagonality of cells in the measured visible field of view between the two instruments.
Measured: 1 day visit per subject.
Secondary outcomes (1)
Investigate Repeatability and Reproducibility between the EM-3000 and NonCon Robo Pachy F&A (CellChek XL) Specular Microscopes
To investigate repeatability (intra-investigator) in the EM-3000 specular microscope in the four outcome measures of the corneal endothelium as well as corneal thickness.
To investigate reproducibility (inter-investigator/instrument) of the EM-3000 specular microscope in the four outcome measures of the corneal endothelium and corneal thickness.
Measured: 1 day visit per subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomey Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University, R. P. Chiacchierini Consulting, LLC
- Responsible party
- Sponsor
- Investigators
- Melissa Bailey, OD, Principal investigator, Professor, College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293122
- Sponsor's protocol ID
- 602-a01
- Status last verified
- Aug 2023
- First submitted
- 13 Nov 2014
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate Agreement Between the EM-3000 and the Predicate Device NonCon Robo Pachy (F&A) (CellChek XL).
- ClinicalTrials.gov ID
- NCT02293122
- Acronym / sponsor ID
- 602-a01
- Conditions
- Cornea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tomey CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Ohio State University, R. P. Chiacchierini Consulting, LLC
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Nov 2014 (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 precision and agreement of the study device, a specular microscope, in comparison to a currently commercially available specular microscope in establishing substantial equivalence of the two devices in clinical use for diagnostic purposes of the human cornea.
Detailed description
The observational clinical investigation is intended to measure agreement between two diagnostic instruments of the eye's corneal endothelium. The study device is the EM-3000 specular microscope and the control device is the NonCon Robo Pachy (F\&A) (CellChek XL) specular microscope. Both instruments measure corneal endothelial cell layer parameters including cell density, coefficient of variation, percent hexagonality, and central thickness.
The primary variable is the measurement of agreement between the two instruments for the four parameters described. The secondary variables include repeatability (intra-investigator) and reproducibility both inter-investigator, and inter-instrument.
Additionally, measurements of agreement will be made on the EM-3000 using automated analysis with and without touch-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: ObservationalObservational group exposure to three test devices and one comparative device. The test Konan Non-con Robo Pachy F\&A Specular Microscope. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study plan calls for 75 subjects divided into three sub-groups, young healthy (18-50 yrs), older healthy (51-80 yrs), and pathologic adults (29-80 years).
Key inclusion criteria (2 listed)
- Eyes with one of the following corneal conditions:
- Non-pathologic younger eyes (18-50 yrs) Non-pathologic older eyes (51-80 yrs) Pathologic adult eyes (29-80)
Key exclusion criteria (9 listed)
- Seriously ill or unconscious subject, mentally ill person, mentally handicapped person, person who is unable to read or write.
- History of corneal transplant
- Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
- Guttata
- History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device
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 |
|---|---|---|
| ObservationalIntervention is observational to two different diagnostic devices for which comparative readings of the corneal endothelium are being measured; the test device- the EM-3000 Specular Microscope against the Konan Robo-pachy F\&A Specular Microscope. | Other | Observational |
Primary outcome
Agreement Between EM-3000 and NonCon Robo Pachy F&A (CellChek XL)
Time frame: 1 day visit per subject.
For Agreement between the two instruments, outcome measures include endothelial cell density (/mm2), coefficient of variation between the two instruments (SD x CD x 10-6, and percent hexagonality of cells in the measured visible field of view between the two instruments.
1 secondary outcome
Investigate Repeatability and Reproducibility between the EM-3000 and NonCon Robo Pachy F&A (CellChek XL) Specular Microscopes
Time frame: 1 day visit per subject.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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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.
Melissa Bailey, OD principal investigator
Professor, College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cornea, run by Tomey Corporation at 1 site in United States.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 22 Aug 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Agreement Between EM-3000 and NonCon Robo Pachy F&A (CellChek XL) (time frame: 1 day visit per subject.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2023.