Corneal Endothelial Cell LossNCT02427256
Second Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
An observational study of Corneal Endothelial Cell Loss, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
The primary objective of this clinical study is to collect additional clinical data to support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Endothelial Cell Loss
- What is being tested?
- Topcon Specular Microscope SP-1P and Konan Specular Microscope CELLCHEK XL
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 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
- No healthy volunteers
- Adult, Older adult
Study population: Ophthalmology Practice
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;
- Long term 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;
- Long term 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 quality SP-1P and CELLCHEK PLUS 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 good quality SP-1P and CELLCHEK PLUS in either eye.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: Comparative Study of the Topcon Specular Microscope SP-1P and the Konan Specular Microscope CELLCHEK XL (Predicate Device) for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area, ％ Hexagonality, Central Corneal Thickness
The primary objective of this clinical study is to collect additional clinical data to support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study.
- Conditions
- Corneal Endothelial Cell Loss
- Being tested
- Topcon Specular Microscope SP-1P, Konan Specular Microscope CELLCHEK XL
- Medical subject headings
- Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topcon Specular Microscope SP-1PDevice
Konan Specular Microscope CELLCHEK XLDevice
| Study group | Role | What they receive |
|---|---|---|
| Non-Pathologic Adults age 18-28 yrs | Not described Receives: Device: Topcon Specular Microscope SP-1P; Device: Konan Specular Microscope CELLCHEK XL | |
| Non-Pathologic Adults age 29-80 yrs | Not described Receives: Device: Topcon Specular Microscope SP-1P; Device: Konan Specular Microscope CELLCHEK XL | |
| Pathologic Adults age 29-80 yrs | Not described Receives: Device: Topcon Specular Microscope SP-1P; Device: Konan Specular Microscope CELLCHEK XL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal endothelial cell density
Measured: Single time point - 1 day
Coefficient of variation of endothelial cell area
Measured: Single time point - 1 day
Corneal endothelial cell % hexagonality
Measured: Single time point - 1 day
Central corneal thickness
Measured: Single time point - 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Endothelial Cell LossStudies 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427256
- Sponsor's protocol ID
- TOPCON-SP-1P-US-0002
- Status last verified
- Jun 2022
- First submitted
- 22 Apr 2015
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Topcon Specular Microscope SP-1P and the Konan Specular Microscope CELLCHEK XL (Predicate Device) for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area, ％ Hexagonality, Central Corneal Thickness
- ClinicalTrials.gov ID
- NCT02427256
- Acronym / sponsor ID
- TOPCON-SP-1P-US-0002
- Conditions
- Corneal Endothelial Cell Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 27 Apr 2015 (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 primary objective of this clinical study is to collect additional clinical data to support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Pathologic Adults age 18-28 yrs | – | Device: Topcon Specular Microscope SP-1P, Device: Konan Specular Microscope CELLCHEK XL |
| Non-Pathologic Adults age 29-80 yrs | – | Device: Topcon Specular Microscope SP-1P, Device: Konan Specular Microscope CELLCHEK XL |
| Pathologic Adults age 29-80 yrs | – | Device: Topcon Specular Microscope SP-1P, Device: Konan Specular Microscope CELLCHEK XL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ophthalmology Practice
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:
- History of post-op surgical trauma including Pseudophakic or Aphakic bullous keratopathy;
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 good quality SP-1P and CELLCHEK PLUS 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 |
|---|---|---|
| Topcon Specular Microscope SP-1P | Device | Non-Pathologic Adults age 18-28 yrs, Non-Pathologic Adults age 29-80 yrs, Pathologic Adults age 29-80 yrs |
| Konan Specular Microscope CELLCHEK XL | Device | Non-Pathologic Adults age 18-28 yrs, Non-Pathologic Adults age 29-80 yrs, Pathologic Adults age 29-80 yrs |
Primary outcome
Corneal endothelial cell density
Time frame: Single time point - 1 day
Coefficient of variation of endothelial cell area
Time frame: Single time point - 1 day
Corneal endothelial cell % hexagonality
Time frame: Single time point - 1 day
Central corneal thickness
Time frame: Single time point - 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 8 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Corneal Endothelial Cell Loss, run by Topcon Medical Systems, Inc. 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 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 8 Jun 2022. 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?
Corneal endothelial cell density (time frame: Single time point - 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 8 Jun 2022.