ClinicalTrials.gg
CompletedNCT02977793Updated Aug 21, 2023

Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
81
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Corneal and Endothelial Cell Measurements
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

Eligibility criteria

Inclusion Criteria-Non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old)

  1. Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the is signed;
  2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
  3. Subjects who agree to participate in the study.

Inclusion Criteria -Pathologic adults (29-80 years old):

  1. 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;
  2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
  3. Subjects who agree to participate in the study;
  4. At least one eye with any of the following conditions:

    1. History of post-op surgical trauma including pseudophakic or aphakic bullous keratopathy
    2. History of corneal transplant
    3. Physical injury or trauma to the cornea
    4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
    5. Keratoconus
    6. 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)

  1. History of post-op surgical trauma including bullous keratopathy;
  2. History of corneal transplant;
  3. Evidence of physical injury or trauma to the cornea;
  4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies;
  5. Keratoconus;
  6. Long-term PMMA contact lens use (greater than 3 years);
  7. History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the device;
  8. 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)

  1. 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;
  2. Fixation problems which may prevent obtaining at least poor quality Tomey EM-4000 and Konan CellChek XL images in either eye.
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
81 participants (actual)
Patient registry
No

Groups and cohorts

  • Non-pathologic young adults

    18-28 years old

    Device: Tomey EM-4000 Specular Microscope · Device: Konan CellChek XL Specular Microscope

  • Non-pathologic adults

    29-80 years old

    Device: Tomey EM-4000 Specular Microscope · Device: Konan CellChek XL Specular Microscope

  • Pathologic adults

    29-80 years old

    Device: Tomey EM-4000 Specular Microscope · Device: Konan CellChek XL Specular Microscope

Interventions

  • DeviceTomey EM-4000 Specular Microscope
  • DeviceKonan CellChek XL Specular Microscope
06

What researchers measure

Primary outcomes

  1. Endothelial cell density measurements

    Time frame: 1 day

  2. Coefficient of variation of endothelial cell area

    Time frame: 1 day

  3. % Hexagonality

    Time frame: 1 day

  4. Central Corneal Thickness

    Time frame: 1 day

Secondary outcomes

  1. Adverse Events

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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.

Registered
Nov 28, 2016
First posted
Nov 30, 2016
StartActual
Oct 2016
Primary completionActual
Jan 2017
CompletionActual
Jan 2017
Last update
Aug 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02977793
Lead sponsor
Tomey Corporation
Responsible party
Sponsor
First posted
Nov 30, 2016
Start date
Oct 2016
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Aug 21, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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