An observational study in Corneal and Endothelial Cell Measurements, sponsored by Tomey Corporation. Completed. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Tomey Corporation · Observational
The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.
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.
Tomey Corporation is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria-Non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old)
Inclusion Criteria -Pathologic adults (29-80 years old):
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)
Exclusion Criteria - Pathologic adults (29-80 years old)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
18-28 years old
Device: Tomey EM-4000 Specular Microscope · Device: Konan CellChek XL Specular Microscope
29-80 years old
Device: Tomey EM-4000 Specular Microscope · Device: Konan CellChek XL Specular Microscope
29-80 years old
Device: Tomey EM-4000 Specular Microscope · Device: Konan CellChek XL Specular Microscope
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
Adverse Events
Time frame: 1 day
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2016 to primary completion in Jan 2017, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Tomey Corporation