- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02977793
Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL
August 17, 2023 updated by: Tomey Corporation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
81
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria-Non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old)
- Male or female subjects from 18 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.
Inclusion Criteria -Pathologic adults (29-80 years old):
- 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
- 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.
Exclusion Criteria - Pathologic adults (29-80 years old)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-pathologic young adults
18-28 years old
|
|
Non-pathologic adults
29-80 years old
|
|
Pathologic adults
29-80 years old
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endothelial cell density measurements
Time Frame: 1 day
|
1 day
|
Coefficient of variation of endothelial cell area
Time Frame: 1 day
|
1 day
|
% Hexagonality
Time Frame: 1 day
|
1 day
|
Central Corneal Thickness
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
November 28, 2016
First Submitted That Met QC Criteria
November 28, 2016
First Posted (Estimated)
November 30, 2016
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 17, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- TOMEY-EM4000-US-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Corneal and Endothelial Cell Measurements
-
Nidek Co. LTD.CompletedCorneal and Endothelial Cell MeasurementsUnited States
-
Assiut UniversityNot yet recruitingEndothelial Cell Loss, Corneal
-
Asociación para Evitar la Ceguera en MéxicoEmmecellRecruiting
-
Prim. Prof. Dr. Oliver Findl, MBACompletedEndothelial Cell Loss, Corneal
-
Centre Hospitalier Régional Metz-ThionvilleCompletedCataract | Endothelial Cell Loss, Corneal | PhacoemulsificationFrance
-
Paracelsus Medical UniversityCompletedGlaucoma | Endothelial Cell Loss, CornealAustria
-
Bausch & Lomb IncorporatedCompletedCorneal Endothelial Cell ChangesUnited States
-
EmmecellRecruitingEndothelial Dysfunction | Corneal Edema | Fuchs Dystrophy | Corneal Endothelial Dystrophy | Bullous Keratopathy | Pseudophakic Bullous Keratopathy | Corneal Endothelial Dysfunction | Fuchs Endothelial Corneal Dystrophy | Moderate Corneal Endothelial DecompensationUnited States
-
Legacy Health SystemDevers Eye Institute; Lions Eye Bank of Oregon Vision Research Laboratory; Fischer...UnknownFuchs' Corneal Endothelial DystrophyUnited States
-
Case Western Reserve UniversityNational Eye Institute (NEI); Jaeb Center for Health ResearchCompletedCornea Preservation Time | Endothelial Keratoplasty | Transplant Success | Endothelial Cell DensityUnited States
Clinical Trials on Tomey EM-4000 Specular Microscope
-
Topcon Medical Systems, Inc.CompletedCorneal Endothelial Cell LossUnited States
-
Topcon Medical Systems, Inc.CompletedCorneal Endothelial Cell LossUnited States
-
Nidek Co. LTD.CompletedCorneal Endothelial Cell LossUnited States
-
Beijing Tsinghua Chang Gung HospitalCompletedCorneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes MellitusDiabetes Mellitus | Cataract
-
Ulucanlar Eye Training and Research HospitalCompletedAge Related Macular Degeneration