Corneal and Endothelial Cell MeasurementsNCT02977793
Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL
An observational study of Corneal and Endothelial Cell Measurements, run by Tomey Corporation.
Trial summary
The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal and Endothelial Cell Measurements
- What is being tested?
- Tomey EM-4000 Specular Microscope and Konan CellChek XL Specular Microscope
- Type of treatment
- Medical device
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jan 2017
- 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: Subjects recruited can be male or female, of any race or ethnicity, ages 18-80 years of age at Visit 1. All subjects enrolled must meet all the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- Subjects who agree to participate in the study;
- At least one eye with any of the following conditions:
- History of post-op surgical trauma including pseudophakic or aphakic bullous keratopathy
- History of corneal transplant
Show all 19Show fewer
- Physical injury or trauma to the cornea
- Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
- Keratoconus
- Long-term polymethyl methacrylate (PMMA) contact lens use (greater than 3 years).
- Exclusion Criteria - Non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old)
- History of post-op surgical trauma including bullous keratopathy;
- History of corneal transplant;
- Evidence of physical injury or trauma to the cornea;
- Fuch's dystrophy, Guttata or other corneal endothelial dystrophies;
- Keratoconus;
- Long-term PMMA contact lens use (greater than 3 years);
- History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
- Fixation problems which may prevent obtaining good Tomey EM-4000 and Konan CellChek XL images in either eye.
Who cannot join
- History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
- Fixation problems which may prevent obtaining at least poor quality Tomey EM-4000 and Konan CellChek XL images in either eye.
About this study
Official title: Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL for the Measurements of Endothelial Cell Density, Coefficient of Variation of Endothelial Cell Area, % Hexagonality, Central Corneal Thickness
The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.
Read the detailed description
The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium by capturing an image of corneal endothelium tissues. without making contact, analyzing the captured image, and calculating data such as cell density.
- Being tested
- Tomey EM-4000 Specular Microscope, Konan CellChek XL Specular Microscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomey EM-4000 Specular MicroscopeDevice
Konan CellChek XL Specular MicroscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Non-pathologic young adults | 18-28 years old Receives: Device: Tomey EM-4000 Specular Microscope; Device: Konan CellChek XL Specular Microscope | |
| Non-pathologic adults | 29-80 years old Receives: Device: Tomey EM-4000 Specular Microscope; Device: Konan CellChek XL Specular Microscope | |
| Pathologic adults | 29-80 years old Receives: Device: Tomey EM-4000 Specular Microscope; Device: Konan CellChek XL Specular Microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell density measurements
Measured: 1 day
Coefficient of variation of endothelial cell area
Measured: 1 day
% Hexagonality
Measured: 1 day
Central Corneal Thickness
Measured: 1 day
Secondary outcomes (1)
Adverse Events
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 posted30 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal and Endothelial Cell MeasurementsStudies 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomey Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977793
- Sponsor's protocol ID
- TOMEY-EM4000-US-001
- Status last verified
- Aug 2023
- First submitted
- 28 Nov 2016
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL for the Measurements of Endothelial Cell Density, Coefficient of Variation of Endothelial Cell Area, % Hexagonality, Central Corneal Thickness
- ClinicalTrials.gov ID
- NCT02977793
- Acronym / sponsor ID
- TOMEY-EM4000-US-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Tomey CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Nov 2016 (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 Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.
Detailed description
The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium by capturing an image of corneal endothelium tissues. without making contact, analyzing the captured image, and calculating data such as cell density.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-pathologic young adults | – | Device: Tomey EM-4000 Specular Microscope, Device: Konan CellChek XL Specular Microscope18-28 years old |
| Non-pathologic adults | – | Device: Tomey EM-4000 Specular Microscope, Device: Konan CellChek XL Specular Microscope29-80 years old |
| Pathologic adults | – | Device: Tomey EM-4000 Specular Microscope, Device: Konan CellChek XL Specular Microscope29-80 years old |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects recruited can be male or female, of any race or ethnicity, ages 18-80 years of age at Visit 1. All subjects enrolled must meet all the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (19 listed)
- Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- Subjects who agree to participate in the study;
- At least one eye with any of the following conditions:
- Exclusion Criteria - Non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old)
Key exclusion criteria (2 listed)
- History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
- Fixation problems which may prevent obtaining at least poor quality Tomey EM-4000 and Konan CellChek XL images in either eye.
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 |
|---|---|---|
| Tomey EM-4000 Specular Microscope | Device | Non-pathologic adults, Non-pathologic young adults, Pathologic adults |
| Konan CellChek XL Specular Microscope | Device | Non-pathologic adults, Non-pathologic young adults, Pathologic adults |
Primary outcome
Endothelial cell density measurements
Time frame: 1 day
Coefficient of variation of endothelial cell area
Time frame: 1 day
% Hexagonality
Time frame: 1 day
Central Corneal Thickness
Time frame: 1 day
1 secondary outcome
Adverse Events
Time frame: 1 day
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 21 Aug 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal and Endothelial Cell Measurements, run by Tomey Corporation.
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 19 inclusion and 2 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Endothelial cell density measurements (time frame: 1 day). The study lists 4 primary outcomes in all. 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 21 Aug 2023.